<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04439071</url>
  </required_header>
  <id_info>
    <org_study_id>PTC299-VIR-015-COV19</org_study_id>
    <secondary_id>2020-001872-13</secondary_id>
    <nct_id>NCT04439071</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Efficacy and Safety of PTC299 (Emvododstat) in Hospitalized Participants With Coronavirus (COVID-19)</brief_title>
  <acronym>FITE19</acronym>
  <official_title>Evaluation of the Efficacy and Safety of PTC299 in Hospitalized Subjects With COVID-19 (FITE19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PTC Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PTC Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, multicenter, 28-day study of adult&#xD;
      participants hospitalized with COVID-19, with a safety follow-up telephone call at Day 60.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Actual">July 20, 2022</completion_date>
  <primary_completion_date type="Actual">July 20, 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time From Randomization to Respiratory Improvement</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Respiratory improvement was defined as sustained peripheral oxygen saturation (SpO2) ≥94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Requiring Invasive Ventilation</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Number of participants requiring invasive ventilation at any time during the study were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Requiring Supplemental Oxygen or Non-Invasive Ventilation in Participants Who Did Not Require Supplemental Oxygen at Baseline</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Number of participants requiring supplemental oxygen or non-invasive ventilation at any point during the study in participants who did not require supplemental oxygen at baseline were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Randomization to Defervescence in Participants Presenting With Fever at Enrollment (Temperature of ≥37.6℃ Axilla, ≥38.0℃ Oral, or ≥38.6°C Tympanic or Rectal)</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Defervescence was defined as body temperature of &lt;37.6° C axilla, &lt;38.0° C oral, or &lt;38.6° C tympanic or rectal without taking any antipyretic treatment and sustained until discharge or Day 28. Median time to defervescence was estimated via the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Randomization to Respiratory Rate ≤ 24 Breaths Per Minute on Room Air</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Median time to respiratory rate in participants who had abnormal respiratory rate at baseline was estimated via the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Randomization to Cough Reported as Mild or Absent</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Cough was rated on a scale of severe, moderate, mild, absent, in those with cough at enrollment rated severe or moderate. Median time to cough reported as mild or absent was estimated via the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Randomization to Dyspnea Reported as Mild or Absent</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Dyspnea was rated on a scale of severe, moderate, mild, absent, in those with dyspnea at enrollment rated as severe or moderate. Median time to dyspnea reported as mild or absent was estimated via the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Cytokine Levels at Day 28</measure>
    <time_frame>Baseline, Day 28</time_frame>
    <description>Cytokines included Granulocyte Colony Stimulating factor; Interleukin 10, 17, 2, 6, 7; Macrophage Inflammatory Protein 1 Alpha; Monocyte Chemotactic Protein 1; and Tumor Necrosis Factor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Level of Acute Phase Protein (C Reactive Protein) at Day 28</measure>
    <time_frame>Baseline, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Level of Acute Phase Protein (D-Dimer) at Day 28</measure>
    <time_frame>Baseline, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Level of Acute Phase Protein (Ferritin) at Day 28</measure>
    <time_frame>Baseline, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Level of Acute Phase Proteins (Troponin I and Troponin T) at Day 28</measure>
    <time_frame>Baseline, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Normalization of Complete Blood Count (CBC) Who Had CBC Out of Range at Baseline</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Number of participants who returned to normal range CBC were reported. CBC included red blood cell (RBC), hemoglobin (HGB), white blood cell (WBC), and Platelets.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Viral Load at Day 28: SARS-CoV-2 Immunoglobulin A (IgA) Antibody Ratio and SARS-CoV-2 Immunoglobulin G (IgG) Antibody Ratio</measure>
    <time_frame>Baseline, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Viral Load at Day 28: SARS-CoV-2 IgM Antibody Absorbance</measure>
    <time_frame>Baseline, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Viral Load at Day 28: SARS-CoV2 v2, SARS-CoV2 v2 Nasopharyngeal Swab (NPsw), and Severe Acute Resp Syndrome Coronavirus 2</measure>
    <time_frame>Baseline, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Hospitalization</measure>
    <time_frame>up to Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Mortalities at Day 28</measure>
    <time_frame>Day 28</time_frame>
    <description>Mortality was defined as a death event occurring at anytime before the specific date, after the first dose has been received.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>up to Day 60</time_frame>
    <description>An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. TEAEs were defined as any AEs that occurred on or after the first study treatment through 30 days after the last dose, or any AEs occurring before the first study treatment but worsening during the treatment through 30 days after the last dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time From Randomization to Respiratory Improvement Where Symptom Onset Occurred ≤5 Days</measure>
    <time_frame>up to Day 28</time_frame>
    <description>Respiratory improvement was defined as SpO2 ≥94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">189</enrollment>
  <condition>Pneumonia</condition>
  <condition>COVID-19</condition>
  <condition>Coronavirus</condition>
  <arm_group>
    <arm_group_label>PTC299 + Standard of Care (SOC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive PTC299 at 200 milligrams (mg), administered orally, twice daily (BID) on Days 1 to 7, then at 50 mg administered orally, once daily (QD) on Days 8 to 14.&#xD;
SOC will also be administered according to local, written policies or guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + SOC</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.&#xD;
SOC will also be administered according to local, written policies or guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PTC299</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>PTC299 + Standard of Care (SOC)</arm_group_label>
    <other_name>Emvododstat</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SOC</intervention_name>
    <description>As defined per local written policies or guidelines.</description>
    <arm_group_label>PTC299 + Standard of Care (SOC)</arm_group_label>
    <arm_group_label>Placebo + SOC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Placebo + SOC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated informed consent document(s).&#xD;
&#xD;
          -  Agrees to the collection of nasopharyngeal swabs and venous blood and all other&#xD;
             protocol-specified procedures.&#xD;
&#xD;
          -  Male or non-pregnant female adult ≥18 years of age at time of enrollment.&#xD;
&#xD;
          -  Hospitalized and has laboratory-confirmed infection with severe acute respiratory&#xD;
             syndrome coronavirus 2 (SARS-CoV-2).&#xD;
&#xD;
          -  Symptom onset was ≤10 days prior to screening.&#xD;
&#xD;
          -  Has oxygen saturation SpO2 &lt;94% on room air.&#xD;
&#xD;
          -  Has at least one of a respiratory rate &gt;24 breaths/minute or cough.&#xD;
&#xD;
          -  Lung involvement as confirmed by radiographic infiltrates observed on imaging (chest&#xD;
             X-ray, computed tomography (CT) scan, or an equivalent test).&#xD;
&#xD;
          -  Women of childbearing potential (as defined in [CTFG 2014]) must have a negative&#xD;
             pregnancy test at screening and agree to abstinence or the use at least one of the&#xD;
             following highly effective forms of contraception (with a failure rate of &lt;1% per year&#xD;
             when used consistently and correctly). Contraception or abstinence must be continued&#xD;
             for the duration of the study following discharge from the hospital, and for up to 50&#xD;
             days after the last dose of study drug:&#xD;
&#xD;
             i) combined (estrogen and progestogen containing) hormonal contraception associated&#xD;
             with inhibition of ovulation: oral, intravaginal, and transdermal ii) progestogen-only&#xD;
             hormonal contraception associated with inhibition of ovulation: oral, injectable, and&#xD;
             implantable iii) intrauterine device iv) intrauterine hormone-releasing system v)&#xD;
             vasectomized partner with confirmed azoospermia All females will be considered of&#xD;
             childbearing potential unless they are postmenopausal (at least 12 months consecutive&#xD;
             amenorrhea in the appropriate age group without other known or suspected cause) or&#xD;
             have been sterilized surgically (for example, bilateral tubal ligation, hysterectomy,&#xD;
             bilateral oophorectomy).&#xD;
&#xD;
          -  Men sexually active with women of childbearing potential who have not had a vasectomy&#xD;
             must agree to use a barrier method of birth control during the study following&#xD;
             discharge from the hospital and for up to 50 days after the last dose of study drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requires mechanical ventilation.&#xD;
&#xD;
          -  Current participation in any other interventional study.&#xD;
&#xD;
          -  Alanine transaminase/aspartate transaminase levels ≥3 times the upper limit of normal&#xD;
             (×ULN) or total bilirubin (Tbili) ≥2×ULN.&#xD;
&#xD;
          -  Lymphocyte count &lt;500 lymphocytes/microliter (μL) or hemoglobin &lt;11 grams/deciliter&#xD;
             (g/dL).&#xD;
&#xD;
          -  Stage 4 severe chronic kidney disease or requiring dialysis (that is, estimated&#xD;
             glomerular filtration rate &lt;30).&#xD;
&#xD;
          -  Any other condition, that in the opinion of the Investigator, may be cause to exclude&#xD;
             the participant from the study.&#xD;
&#xD;
          -  Use of steroids (except dexamethasone), sensitive CYP2D6 substrates, CYP2C inducers,&#xD;
             IL-6 neutralizing antibodies, IL-6 receptor inhibitors, or any investigational&#xD;
             therapy.&#xD;
&#xD;
          -  Pregnancy or breast feeding.&#xD;
&#xD;
          -  Anticipated transfer to another hospital which is not a study site within 72 hours.&#xD;
&#xD;
          -  Known allergy to PTC299 or excipients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Quintus Ngumah, OD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>PTC Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Memorial Health Care</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ralph H. Johnson VA Medical Center</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>02145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunshine Hospital</name>
      <address>
        <city>St. Albans</city>
        <state>Victoria</state>
        <zip>03021</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Pierre University Hospital</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint Pierre</name>
      <address>
        <city>Ottignies</city>
        <zip>B-1340</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vera Cruz</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30190-130</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Moinhos de Vento</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Unimed (CHU) - Joinville</name>
      <address>
        <city>Joinville</city>
        <state>SC</state>
        <zip>89204-061</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Guilherme Alvaro</name>
      <address>
        <city>Santos</city>
        <state>SP</state>
        <zip>11045-904</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Casa de Misecórdia de Sorocoba</name>
      <address>
        <city>Sorocaba</city>
        <state>SP</state>
        <zip>18013-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alemao Oswaldo Cruz</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>01508-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Escola Paulista de Medicina (UNIFESP)</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>04023-062</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundação Faculdade Regional de Medicina de São José do Rio Preto</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Santa Fe de Bogotá</name>
      <address>
        <city>Bogotá</city>
        <zip>110311</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Cardiovascular Somer Incare</name>
      <address>
        <city>Rionegro</city>
        <zip>054040</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalario MAC</name>
      <address>
        <city>Irapuato</city>
        <state>Guanajuato</state>
        <zip>36520</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr. José Eleuterio Gonzalez</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integra RGH Centro de Investigación/ Hospital MAC Puebla</name>
      <address>
        <city>Puebla</city>
        <zip>72410</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SOMECO - Sociedad de Metabolismo y Corazón S.C.</name>
      <address>
        <city>Veracruz</city>
        <zip>91910</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Clinic Hospital of the MSWiA in Warsaw</name>
      <address>
        <city>Warsaw</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário de Lisboa Norte (CHULN), E.P.E - Hospital de Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Entre o Douro e Vouga, EPE (CHEDV)</name>
      <address>
        <city>Santa Maria da Feira</city>
        <zip>4520-211</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE (CHVNG/E)</name>
      <address>
        <city>Vila Nova de Gaia</city>
        <zip>4434-502</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Worthwhile Clinical Trials</name>
      <address>
        <city>Benoni</city>
        <zip>1500</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TREAD Research</name>
      <address>
        <city>Cape Town</city>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tiervlei Trial Centre</name>
      <address>
        <city>Cape Town</city>
        <zip>7530</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ahmed Al-Kadi Private Hospital</name>
      <address>
        <city>Durban</city>
        <zip>4058</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Clinical Trials</name>
      <address>
        <city>Pretoria</city>
        <zip>0001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Infanta Leonor</name>
      <address>
        <city>Madrid</city>
        <zip>28031</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Infanta Sofía</name>
      <address>
        <city>San Sebastián de los Reyes</city>
        <zip>28702</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Colombia</country>
    <country>France</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217411&amp;amp;parentIdentifier=PTC299-VIR-015-COV19&amp;amp;attachmentIdentifier=642c87e2-eb4d-4a5c-85e5-1df1ccd361ef&amp;amp;fileName=Global_PTC299-VIR-015-COV19_Clinical_Protocol_V7.0_-_02JUN2021_final_redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>FINAL REDACTED PROTOCOL</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <results_first_submitted>May 30, 2023</results_first_submitted>
  <results_first_submitted_qc>May 30, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 26, 2023</results_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 2, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT04439071/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 19, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT04439071/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PTC299</title>
          <description>Participants received PTC299 at 200 milligrams (mg), administered orally, twice daily (BID) on Days 1 to 7, then at 50 mg administered orally, once daily (QD) on Days 8 to 14.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="94"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but not treated</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included all randomized participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>PTC299</title>
          <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="92"/>
            <count group_id="B2" value="95"/>
            <count group_id="B3" value="187"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.0" spread="12.44"/>
                    <measurement group_id="B2" value="52.7" spread="12.48"/>
                    <measurement group_id="B3" value="52.3" spread="12.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time From Randomization to Respiratory Improvement</title>
        <description>Respiratory improvement was defined as sustained peripheral oxygen saturation (SpO2) ≥94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.</description>
        <time_frame>up to Day 28</time_frame>
        <population>Intent-to-treat (ITT) population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomization to Respiratory Improvement</title>
          <description>Respiratory improvement was defined as sustained peripheral oxygen saturation (SpO2) ≥94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.</description>
          <population>Intent-to-treat (ITT) population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="6.0" upper_limit="15.0"/>
                    <measurement group_id="O2" value="10.0" lower_limit="8.0" upper_limit="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Time to respiratory improvement was compared between treatment groups using stratified log-rank test.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.949</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Requiring Invasive Ventilation</title>
        <description>Number of participants requiring invasive ventilation at any time during the study were reported.</description>
        <time_frame>up to Day 28</time_frame>
        <population>ITT population included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring Invasive Ventilation</title>
          <description>Number of participants requiring invasive ventilation at any time during the study were reported.</description>
          <population>ITT population included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Requiring Supplemental Oxygen or Non-Invasive Ventilation in Participants Who Did Not Require Supplemental Oxygen at Baseline</title>
        <description>Number of participants requiring supplemental oxygen or non-invasive ventilation at any point during the study in participants who did not require supplemental oxygen at baseline were reported.</description>
        <time_frame>up to Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring Supplemental Oxygen or Non-Invasive Ventilation in Participants Who Did Not Require Supplemental Oxygen at Baseline</title>
          <description>Number of participants requiring supplemental oxygen or non-invasive ventilation at any point during the study in participants who did not require supplemental oxygen at baseline were reported.</description>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Randomization to Defervescence in Participants Presenting With Fever at Enrollment (Temperature of ≥37.6℃ Axilla, ≥38.0℃ Oral, or ≥38.6°C Tympanic or Rectal)</title>
        <description>Defervescence was defined as body temperature of &lt;37.6° C axilla, &lt;38.0° C oral, or &lt;38.6° C tympanic or rectal without taking any antipyretic treatment and sustained until discharge or Day 28. Median time to defervescence was estimated via the Kaplan-Meier method.</description>
        <time_frame>up to Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomization to Defervescence in Participants Presenting With Fever at Enrollment (Temperature of ≥37.6℃ Axilla, ≥38.0℃ Oral, or ≥38.6°C Tympanic or Rectal)</title>
          <description>Defervescence was defined as body temperature of &lt;37.6° C axilla, &lt;38.0° C oral, or &lt;38.6° C tympanic or rectal without taking any antipyretic treatment and sustained until discharge or Day 28. Median time to defervescence was estimated via the Kaplan-Meier method.</description>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="5.0" upper_limit="28.0"/>
                    <measurement group_id="O2" value="18.0" lower_limit="4.0" upper_limit="NA">Due to smaller number of participants with an event, upper limit of 95% confidence interval (CI) could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Randomization to Respiratory Rate ≤ 24 Breaths Per Minute on Room Air</title>
        <description>Median time to respiratory rate in participants who had abnormal respiratory rate at baseline was estimated via the Kaplan-Meier method.</description>
        <time_frame>up to Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomization to Respiratory Rate ≤ 24 Breaths Per Minute on Room Air</title>
          <description>Median time to respiratory rate in participants who had abnormal respiratory rate at baseline was estimated via the Kaplan-Meier method.</description>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="5.0" upper_limit="11.0"/>
                    <measurement group_id="O2" value="8.0" lower_limit="6.0" upper_limit="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Randomization to Cough Reported as Mild or Absent</title>
        <description>Cough was rated on a scale of severe, moderate, mild, absent, in those with cough at enrollment rated severe or moderate. Median time to cough reported as mild or absent was estimated via the Kaplan-Meier method.</description>
        <time_frame>up to Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomization to Cough Reported as Mild or Absent</title>
          <description>Cough was rated on a scale of severe, moderate, mild, absent, in those with cough at enrollment rated severe or moderate. Median time to cough reported as mild or absent was estimated via the Kaplan-Meier method.</description>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="3.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="5.0" lower_limit="3.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Randomization to Dyspnea Reported as Mild or Absent</title>
        <description>Dyspnea was rated on a scale of severe, moderate, mild, absent, in those with dyspnea at enrollment rated as severe or moderate. Median time to dyspnea reported as mild or absent was estimated via the Kaplan-Meier method.</description>
        <time_frame>up to Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomization to Dyspnea Reported as Mild or Absent</title>
          <description>Dyspnea was rated on a scale of severe, moderate, mild, absent, in those with dyspnea at enrollment rated as severe or moderate. Median time to dyspnea reported as mild or absent was estimated via the Kaplan-Meier method.</description>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="3.0" upper_limit="9.0"/>
                    <measurement group_id="O2" value="5.0" lower_limit="4.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Cytokine Levels at Day 28</title>
        <description>Cytokines included Granulocyte Colony Stimulating factor; Interleukin 10, 17, 2, 6, 7; Macrophage Inflammatory Protein 1 Alpha; Monocyte Chemotactic Protein 1; and Tumor Necrosis Factor.</description>
        <time_frame>Baseline, Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Cytokine Levels at Day 28</title>
          <description>Cytokines included Granulocyte Colony Stimulating factor; Interleukin 10, 17, 2, 6, 7; Macrophage Inflammatory Protein 1 Alpha; Monocyte Chemotactic Protein 1; and Tumor Necrosis Factor.</description>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>nanograms (ng)/liter (L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Granulocyte Colony Stimulating Factor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.423" spread="0.4431"/>
                    <measurement group_id="O2" value="-0.467" spread="0.4750"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interleukin 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.367" spread="0.4655"/>
                    <measurement group_id="O2" value="-0.491" spread="0.4003"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interleukin 17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.018" spread="0.1447"/>
                    <measurement group_id="O2" value="0.002" spread="0.1425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interleukin 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.021" spread="0.0868"/>
                    <measurement group_id="O2" value="0.022" spread="0.1448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interleukin 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.375" spread="0.5274"/>
                    <measurement group_id="O2" value="-0.442" spread="0.5062"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interleukin 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.025" spread="0.1233"/>
                    <measurement group_id="O2" value="-0.035" spread="0.1556"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Macrophage Inflammatory Protein 1 Alpha</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.072" spread="0.2459"/>
                    <measurement group_id="O2" value="0.044" spread="0.1888"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocyte Chemotactic Protein 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.011" spread="0.4077"/>
                    <measurement group_id="O2" value="0.018" spread="0.3804"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tumor Necrosis Factor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.015" spread="0.1509"/>
                    <measurement group_id="O2" value="-0.027" spread="0.1666"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Level of Acute Phase Protein (C Reactive Protein) at Day 28</title>
        <time_frame>Baseline, Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Level of Acute Phase Protein (C Reactive Protein) at Day 28</title>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.027" spread="0.5966"/>
                    <measurement group_id="O2" value="-1.111" spread="0.5633"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Level of Acute Phase Protein (D-Dimer) at Day 28</title>
        <time_frame>Baseline, Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Level of Acute Phase Protein (D-Dimer) at Day 28</title>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>micrograms (µg)/L D-dimer units (DDU)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.029" spread="0.9278"/>
                    <measurement group_id="O2" value="-0.121" spread="0.9392"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Level of Acute Phase Protein (Ferritin) at Day 28</title>
        <time_frame>Baseline, Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Level of Acute Phase Protein (Ferritin) at Day 28</title>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>picomoles (pmol)/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.410" spread="0.3096"/>
                    <measurement group_id="O2" value="-0.497" spread="0.3162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Level of Acute Phase Proteins (Troponin I and Troponin T) at Day 28</title>
        <time_frame>Baseline, Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Level of Acute Phase Proteins (Troponin I and Troponin T) at Day 28</title>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.</population>
          <units>µg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Troponin I</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.080" spread="1.5879"/>
                    <measurement group_id="O2" value="-0.036" spread="0.2128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Troponin T</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.001" spread="0.0015"/>
                    <measurement group_id="O2" value="0.061" spread="0.1638"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Normalization of Complete Blood Count (CBC) Who Had CBC Out of Range at Baseline</title>
        <description>Number of participants who returned to normal range CBC were reported. CBC included red blood cell (RBC), hemoglobin (HGB), white blood cell (WBC), and Platelets.</description>
        <time_frame>up to Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Normalization of Complete Blood Count (CBC) Who Had CBC Out of Range at Baseline</title>
          <description>Number of participants who returned to normal range CBC were reported. CBC included red blood cell (RBC), hemoglobin (HGB), white blood cell (WBC), and Platelets.</description>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>RBC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HGB</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Viral Load at Day 28: SARS-CoV-2 Immunoglobulin A (IgA) Antibody Ratio and SARS-CoV-2 Immunoglobulin G (IgG) Antibody Ratio</title>
        <time_frame>Baseline, Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Viral Load at Day 28: SARS-CoV-2 Immunoglobulin A (IgA) Antibody Ratio and SARS-CoV-2 Immunoglobulin G (IgG) Antibody Ratio</title>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SARS-CoV-2 IgA Antibody Ratio</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.003" spread="0.6387"/>
                    <measurement group_id="O2" value="0.165" spread="0.5122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SARS-CoV-2 IgG Antibody Ratio</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.890" spread="0.6846"/>
                    <measurement group_id="O2" value="0.874" spread="0.7604"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Viral Load at Day 28: SARS-CoV-2 IgM Antibody Absorbance</title>
        <time_frame>Baseline, Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Viral Load at Day 28: SARS-CoV-2 IgM Antibody Absorbance</title>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>absorbance (Abs)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="0.4691"/>
                    <measurement group_id="O2" value="0.127" spread="0.4218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Viral Load at Day 28: SARS-CoV2 v2, SARS-CoV2 v2 Nasopharyngeal Swab (NPsw), and Severe Acute Resp Syndrome Coronavirus 2</title>
        <time_frame>Baseline, Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Viral Load at Day 28: SARS-CoV2 v2, SARS-CoV2 v2 Nasopharyngeal Swab (NPsw), and Severe Acute Resp Syndrome Coronavirus 2</title>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.</population>
          <units>copies/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SARS-CoV2 v2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.345" spread="0.2235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SARS-CoV2 v2 NPsw</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.201" spread="0.7503"/>
                    <measurement group_id="O2" value="1.532"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Acute Resp Syndrome Coronavirus 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Hospitalization</title>
        <time_frame>up to Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Hospitalization</title>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="4.87"/>
                    <measurement group_id="O2" value="9.3" spread="5.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Mortalities at Day 28</title>
        <description>Mortality was defined as a death event occurring at anytime before the specific date, after the first dose has been received.</description>
        <time_frame>Day 28</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Mortalities at Day 28</title>
          <description>Mortality was defined as a death event occurring at anytime before the specific date, after the first dose has been received.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. TEAEs were defined as any AEs that occurred on or after the first study treatment through 30 days after the last dose, or any AEs occurring before the first study treatment but worsening during the treatment through 30 days after the last dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.</description>
        <time_frame>up to Day 60</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. TEAEs were defined as any AEs that occurred on or after the first study treatment through 30 days after the last dose, or any AEs occurring before the first study treatment but worsening during the treatment through 30 days after the last dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time From Randomization to Respiratory Improvement Where Symptom Onset Occurred ≤5 Days</title>
        <description>Respiratory improvement was defined as SpO2 ≥94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.</description>
        <time_frame>up to Day 28</time_frame>
        <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PTC299</title>
            <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomization to Respiratory Improvement Where Symptom Onset Occurred ≤5 Days</title>
          <description>Respiratory improvement was defined as SpO2 ≥94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.</description>
          <population>ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="4.0" upper_limit="28.0"/>
                    <measurement group_id="O2" value="28.0" lower_limit="7.0" upper_limit="NA">Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Time to respiratory improvement was compared between treatment groups using stratified log-rank test.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.033</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to Day 60</time_frame>
      <desc>Safety population included all randomized participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>PTC299</title>
          <description>Participants received PTC299 at 200 mg, administered orally, BID on Days 1 to 7, then at 50 mg administered orally, QD on Days 8 to 14.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants received PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 25.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Right ventricular dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pneumonia acinetobacter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Dengue fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Organising pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 25.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="63" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Condition aggravated</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Sponsor can review results and/or communications prior to public release and can embargo communications regarding trial results for a period that is up to 180 days from the time submitted to the sponsor for review. The sponsor may consult with the PI to require changes to the communication or extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Patient Advocacy</name_or_title>
      <organization>PTC Therapeutics, Inc.</organization>
      <phone>1-866-562-4620</phone>
      <email>medinfo@ptcbio.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04439071
org study id: PTC299-VIR-015-COV19
secondary id: 2020-001872-13
nct id: NCT04439071
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, placebo-controlled, multicenter, 28-day study of adult
      participants hospitalized with COVID-19, with a safety follow-up telephone call at Day 60.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time From Randomization to Respiratory Improvement
time frame: up to Day 28
description: Respiratory improvement was defined as sustained peripheral oxygen saturation (SpO2) ≥94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.
measure: Number of Participants Requiring Invasive Ventilation
time frame: up to Day 28
description: Number of participants requiring invasive ventilation at any time during the study were reported.
measure: Number of Participants Requiring Supplemental Oxygen or Non-Invasive Ventilation in Participants Who Did Not Require Supplemental Oxygen at Baseline
time frame: up to Day 28
description: Number of participants requiring supplemental oxygen or non-invasive ventilation at any point during the study in participants who did not require supplemental oxygen at baseline were reported.
measure: Time From Randomization to Defervescence in Participants Presenting With Fever at Enrollment (Temperature of ≥37.6℃ Axilla, ≥38.0℃ Oral, or ≥38.6°C Tympanic or Rectal)
time frame: up to Day 28
description: Defervescence was defined as body temperature of <37.6° C axilla, <38.0° C oral, or <38.6° C tympanic or rectal without taking any antipyretic treatment and sustained until discharge or Day 28. Median time to defervescence was estimated via the Kaplan-Meier method.
measure: Time From Randomization to Respiratory Rate ≤ 24 Breaths Per Minute on Room Air
time frame: up to Day 28
description: Median time to respiratory rate in participants who had abnormal respiratory rate at baseline was estimated via the Kaplan-Meier method.
measure: Time From Randomization to Cough Reported as Mild or Absent
time frame: up to Day 28
description: Cough was rated on a scale of severe, moderate, mild, absent, in those with cough at enrollment rated severe or moderate. Median time to cough reported as mild or absent was estimated via the Kaplan-Meier method.
measure: Time From Randomization to Dyspnea Reported as Mild or Absent
time frame: up to Day 28
description: Dyspnea was rated on a scale of severe, moderate, mild, absent, in those with dyspnea at enrollment rated as severe or moderate. Median time to dyspnea reported as mild or absent was estimated via the Kaplan-Meier method.
measure: Change From Baseline in Cytokine Levels at Day 28
time frame: Baseline, Day 28
description: Cytokines included Granulocyte Colony Stimulating factor; Interleukin 10, 17, 2, 6, 7; Macrophage Inflammatory Protein 1 Alpha; Monocyte Chemotactic Protein 1; and Tumor Necrosis Factor.
measure: Change From Baseline in Level of Acute Phase Protein (C Reactive Protein) at Day 28
time frame: Baseline, Day 28
measure: Change From Baseline in Level of Acute Phase Protein (D-Dimer) at Day 28
time frame: Baseline, Day 28
measure: Change From Baseline in Level of Acute Phase Protein (Ferritin) at Day 28
time frame: Baseline, Day 28
measure: Change From Baseline in Level of Acute Phase Proteins (Troponin I and Troponin T) at Day 28
time frame: Baseline, Day 28
measure: Number of Participants With Normalization of Complete Blood Count (CBC) Who Had CBC Out of Range at Baseline
time frame: up to Day 28
description: Number of participants who returned to normal range CBC were reported. CBC included red blood cell (RBC), hemoglobin (HGB), white blood cell (WBC), and Platelets.
measure: Change From Baseline in Viral Load at Day 28: SARS-CoV-2 Immunoglobulin A (IgA) Antibody Ratio and SARS-CoV-2 Immunoglobulin G (IgG) Antibody Ratio
time frame: Baseline, Day 28
measure: Change From Baseline in Viral Load at Day 28: SARS-CoV-2 IgM Antibody Absorbance
time frame: Baseline, Day 28
measure: Change From Baseline in Viral Load at Day 28: SARS-CoV2 v2, SARS-CoV2 v2 Nasopharyngeal Swab (NPsw), and Severe Acute Resp Syndrome Coronavirus 2
time frame: Baseline, Day 28
measure: Duration of Hospitalization
time frame: up to Day 28
measure: Number of Mortalities at Day 28
time frame: Day 28
description: Mortality was defined as a death event occurring at anytime before the specific date, after the first dose has been received.
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
time frame: up to Day 60
description: An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. TEAEs were defined as any AEs that occurred on or after the first study treatment through 30 days after the last dose, or any AEs occurring before the first study treatment but worsening during the treatment through 30 days after the last dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
measure: Time From Randomization to Respiratory Improvement Where Symptom Onset Occurred ≤5 Days
time frame: up to Day 28
description: Respiratory improvement was defined as SpO2 ≥94% on room air. Median time to respiratory improvement was estimated via the Kaplan-Meier product limit method.
arm group label: PTC299 + Standard of Care (SOC)
arm group type: Experimental
description: Participants will receive PTC299 at 200 milligrams (mg), administered orally, twice daily (BID) on Days 1 to 7, then at 50 mg administered orally, once daily (QD) on Days 8 to 14.
SOC will also be administered according to local, written policies or guidelines.
arm group label: Placebo + SOC
arm group type: Placebo Comparator
description: Participants will receive PTC299-matching placebo administered orally, BID on Days 1 to 7, then administered orally, QD on Days 8 to 14.
SOC will also be administered according to local, written policies or guidelines.
intervention type: Drug
intervention name: PTC299
description: Oral tablets
arm group label: PTC299 + Standard of Care (SOC)
other name: Emvododstat
intervention type: Other
intervention name: SOC
description: As defined per local written policies or guidelines.
arm group label: PTC299 + Standard of Care (SOC)
arm group label: Placebo + SOC
intervention type: Drug
intervention name: Placebo
description: Oral tablets
arm group label: Placebo + SOC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Quintus Ngumah, OD, PhD
role: Study Director
affiliation: PTC Therapeutics
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country: Australia
country: Belgium
country: Brazil
country: Colombia
country: France
country: Mexico
country: Poland
country: Portugal
country: South Africa
country: Spain
country: United States
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217411&amp;parentIdentifier=PTC299-VIR-015-COV19&amp;attachmentIdentifier=642c87e2-eb4d-4a5c-85e5-1df1ccd361ef&amp;fileName=Global_PTC299-VIR-015-COV19_Clinical_Protocol_V7.0_-_02JUN2021_final_redacted.pdf&amp;versionIdentifier=
description: FINAL REDACTED PROTOCOL
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: Undecided
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 