<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/NCT04405570</url>
  </required_header>
  <id_info>
    <org_study_id>EIDD-2801-2003</org_study_id>
    <nct_id>NCT04405570</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19</brief_title>
  <official_title>A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of EIDD-2801 to Eliminate SARS-CoV-2RNA Detection in Persons With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ridgeback Biotherapeutics, LP</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ridgeback Biotherapeutics, LP</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare&#xD;
      the safety, tolerability, and antiviral activity of EIDD-2801 (molnupiravir) versus placebo&#xD;
      as measured by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare&#xD;
      the safety, tolerability, and antiviral activity of molnupiravir versus placebo as measured&#xD;
      by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19. The study&#xD;
      was a multicenter trial that was conducted in the United States.&#xD;
&#xD;
      In this study, 204 participants were randomized and 202 received molnupiravir or placebo&#xD;
      orally twice a day (BID) for 5 days. The study enrolled participants in 5 parts with each&#xD;
      part evaluating molnupiravir doses of either 200 mg BID, 400 mg BID, or 800 mg BID. Doses&#xD;
      were chosen based on emerging virology and safety data from this and ongoing studies. New&#xD;
      dose groups were started after the selected dose had been studied for safety in a Phase 1&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">February 21, 2021</completion_date>
  <primary_completion_date type="Actual">February 21, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs</measure>
    <time_frame>28 days</time_frame>
    <description>The number of participants until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test.&#xD;
Non detectable defined as &quot;a viral load below the limit of quantification</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Clearance of SARS-CoV-2 in Nasopharyngeal Swabs</measure>
    <time_frame>28 days</time_frame>
    <description>The distribution of days until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test.&#xD;
Non detectable defined as &quot;a viral load below the limit of quantification</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) Grade 3 or Higher or Leading to Discontinuation of Study Treatment</measure>
    <time_frame>28 days</time_frame>
    <description>1) any AEs leading to early discontinuation of blinded treatment (active or placebo), 2) study drug-related discontinuation of treatment, 3) new grade 3 or higher AEs (not already present at baseline), and 4) study drug-related new grade 3 or higher AEs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Adverse Events (AEs), Grade 2 or Higher</measure>
    <time_frame>28 days</time_frame>
    <description>Measure the safety and tolerability of EIDD-2801 by estimating the occurrence of Grade 2 or higher AE and drug related AEs.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">204</enrollment>
  <condition>SARS-CoV-2 Infection, COVID-19</condition>
  <arm_group>
    <arm_group_label>Molnupiravir 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Molnupiravir 200 mg, twice daily (BID) for 5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Molnupiravir 400 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Molnupiravir 400 mg, twice daily (BID) for 5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Molnupiravir 800 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Molnupiravir 800 mg, twice daily (BID) for 5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (PBO) twice daily (BID) for 5 days</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Molnupiravir 200 mg</intervention_name>
    <description>Oral capsule of molnupiravir</description>
    <arm_group_label>Molnupiravir 200 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Molnupiravir 400 mg</intervention_name>
    <description>Oral capsule of molnupiravir</description>
    <arm_group_label>Molnupiravir 400 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Molnupiravir 800 mg</intervention_name>
    <description>Oral capsule of molnupiravir</description>
    <arm_group_label>Molnupiravir 800 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (PBO)</intervention_name>
    <description>placebo oral capsule</description>
    <arm_group_label>Placebo (PBO) twice daily (BID) for 5 days</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to provide informed consent prior to initiation of any study procedures.&#xD;
&#xD;
          2. ≥18 years of age at Screening.&#xD;
&#xD;
          3. Study treatment is expected to begin within ≤168 hours from first symptom onset.&#xD;
&#xD;
          4. Ability to swallow pills.&#xD;
&#xD;
          5. Documentation of confirmed active SARS-CoV-2 infection, as determined by a molecular&#xD;
             or non-molecular (&quot;rapid&quot;) test conducted at any clinic or laboratory that had a&#xD;
             Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent from&#xD;
             a sample collected ≤96 hours prior to study entry.&#xD;
&#xD;
          6. Was experiencing at least one of the following SARS-CoV-2 infection symptoms at the&#xD;
             time of enrollment: fever (could be subjective including feeling feverish or having&#xD;
             chills) OR signs/symptoms of respiratory illness (including but not limited to upper&#xD;
             respiratory congestion, loss of sense of smell or taste, sore throat OR lower&#xD;
             respiratory illness - cough, shortness of breath).&#xD;
&#xD;
          7. Agreed to not participate in another interventional clinical trial for the treatment&#xD;
             of SARS-CoV-2 during the study period (28 days) unless hospitalized.&#xD;
&#xD;
          8. Agreed to not obtain investigational medications outside of the molnupiravir study.&#xD;
&#xD;
          9. Agreed to the sampling detailed in the schedule of evaluations and to comply with&#xD;
             study requirements including contraception requirements.&#xD;
&#xD;
         10. A female participant was eligible to participate if she was not pregnant or&#xD;
             breastfeeding and at least one of the following conditions applied:&#xD;
&#xD;
               -  Was not a woman of childbearing potential (WOCBP) OR&#xD;
&#xD;
               -  Was a WOCBP and using a contraceptive method that is highly effective (a low user&#xD;
                  dependency method OR a user-dependent method in combination with a barrier&#xD;
                  method), or was abstinent from heterosexual intercourse as their preferred and&#xD;
                  usual lifestyle (abstinent on a long-term and persistent basis), as described in&#xD;
                  Appendix 2 of the study protocol during the intervention period and for at least&#xD;
                  50 days after the last dose of study intervention. The investigator evaluated the&#xD;
                  potential for contraceptive method failure (ie, noncompliance, recently&#xD;
                  initiated) in relationship to the first dose of study intervention.&#xD;
&#xD;
               -  A WOCBP must have had a negative highly sensitive pregnancy test (serum or urine)&#xD;
                  within 24 hours before the first dose of study intervention.&#xD;
&#xD;
               -  Additional requirements for pregnancy testing during and after study intervention&#xD;
                  were provided in the study protocol.&#xD;
&#xD;
               -  The investigator was responsible for review of medical history, menstrual&#xD;
                  history, and recent sexual activity to decrease the risk for inclusion of a woman&#xD;
                  with an early undetected pregnancy.&#xD;
&#xD;
               -  Contraceptive use by women was to be consistent with local regulations regarding&#xD;
                  the methods of contraception for those participating in clinical studies.&#xD;
&#xD;
               -  Given the elevated risk of venous thrombotic events in patients hospitalized with&#xD;
                  COVID-19 (Benson et al, 2020; Spratt et al, 2020), estrogen-containing&#xD;
                  contraceptives could not be started to fulfill the contraceptive requirement of&#xD;
                  this study at any time during participant's participation. If contraceptives were&#xD;
                  interrupted as standard of care management of COVID-19 patients and resumed at a&#xD;
                  later time point, such as at hospital discharge, then abstinence was practiced&#xD;
                  for the defined period of back-up contraception per the contraceptive product&#xD;
                  labeling. After this period, contraceptive use had to adhere to the guidance in&#xD;
                  Appendix 2 of the study protocol.&#xD;
&#xD;
         11. Male participants were eligible to participate if they agreed to the following during&#xD;
             the intervention period and for at least 100 days after the last dose of study&#xD;
             intervention:&#xD;
&#xD;
               -  Refrained from donating sperm&#xD;
&#xD;
        PLUS either:&#xD;
&#xD;
          -  Were abstinent from heterosexual intercourse as their preferred and usual lifestyle&#xD;
             (abstinent on a long term and persistent basis) and agreed to remain abstinent.&#xD;
&#xD;
        OR&#xD;
&#xD;
          -  Had to agree to use contraception unless confirmed to be azoospermic (vasectomized or&#xD;
             secondary to medical cause [Appendix 2 of the study protocol]) as detailed below:&#xD;
&#xD;
               -  Agreed to use a male condom plus partner use of an additional contraceptive&#xD;
                  method when having penile-vaginal intercourse with a WOCBP who was not pregnant.&#xD;
                  Note: Men with a pregnant or breastfeeding partner had to agree to remain&#xD;
                  abstinent from penile-vaginal intercourse or use a male condom during each&#xD;
                  episode of penile-vaginal penetration.&#xD;
&#xD;
               -  Contraceptive use by men was to be consistent with local regulations regarding&#xD;
                  the methods of contraception for those participating in clinical studies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Need for hospitalization or immediate medical attention in the clinical opinion of the&#xD;
             study investigator.&#xD;
&#xD;
          2. Hemoglobin &lt;10 g/dL in men and &lt;9 g/dL in women.&#xD;
&#xD;
          3. Platelet count &lt;100,000/ µL or received a platelet transfusion within 5 days prior to&#xD;
             enrollment.&#xD;
&#xD;
          4. Was on dialysis or has an estimated glomerular filtration rate &lt;30 mL/min/1.73 m^2&#xD;
&#xD;
          5. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) &gt;3x upper limit normal&#xD;
             (ULN).&#xD;
&#xD;
          6. History of or current hospitalization for COVID-19. Note: Individuals hospitalized and&#xD;
             then discharged, even if only hospitalized for 1 day, were excluded.&#xD;
&#xD;
          7. History of kidney disease as evidenced by estimated creatinine clearance value &lt;30&#xD;
             mL/min.&#xD;
&#xD;
          8. History of significant liver disease in the opinion of the site investigator or active&#xD;
             hepatitis B or active hepatitis C. Human immunodeficiency virus (HIV) that is advanced&#xD;
             (CD4&lt;200/mm^3) and/or on treatment with nucleos(t)ide analogues.&#xD;
&#xD;
          9. Use of therapeutic interventions with possible anti-SARS-CoV-2 activity within 30 days&#xD;
             prior to study entry, (e.g., remdesivir, lopinavir/ritonavir fixed dose combination,&#xD;
             ribavirin, chloroquine, hydroxychloroquine, and convalescent plasma), or participation&#xD;
             in a clinical trial involving any of these drugs whether for treatment or prophylaxis.&#xD;
&#xD;
         10. Receipt of a SARS-CoV-2 vaccination prior to study entry.&#xD;
&#xD;
         11. Known allergy/sensitivity or any hypersensitivity to components of molnupiravir, or&#xD;
             its formulation.&#xD;
&#xD;
         12. Active drug or alcohol use or dependence that, in the opinion of the site&#xD;
             investigator, would interfere with adherence to study requirements.&#xD;
&#xD;
         13. History of recent (within the past 3 months) hemorrhagic cerebrovascular accident) or&#xD;
             major bleed.&#xD;
&#xD;
         14. Presence of a condition, that in the opinion of the investigator, would place the&#xD;
             subject at increased risk from study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Valley Clinical Trials, Inc.</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FOMAT Medical Research</name>
      <address>
        <city>Oxnard</city>
        <state>California</state>
        <zip>93030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Emergency Medicine</name>
      <address>
        <city>Yucaipa</city>
        <state>California</state>
        <zip>92399</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indago Research and Health Center, Inc.</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NOLA Research Works, LLC</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina School of Medicine</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care United Research, LLC</name>
      <address>
        <city>Forney</city>
        <state>Texas</state>
        <zip>75126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.46621/UYGR2287</url>
    <description>Benson et al, 2020. Society of Family Planning interim clinical recommendations</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <results_first_submitted>January 18, 2022</results_first_submitted>
  <results_first_submitted_qc>February 14, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 16, 2022</results_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2022</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Molnupiravir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available.</ipd_description>
  </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>November 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT04405570/Prot_003.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>February 18, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT04405570/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Molnupiravir 200 mg</title>
          <description>molnupiravir twice daily (BID) for 5 days</description>
        </group>
        <group group_id="P2">
          <title>Molnupiravir 400 mg</title>
          <description>molnupiravir twice daily (BID) for 5 days</description>
        </group>
        <group group_id="P3">
          <title>Molnupiravir 800 mg</title>
          <description>molnupiravir twice daily (BID) for 5 days</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Placebo twice daily (BID) for 5 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="64"/>
                <participants group_id="P3" count="55"/>
                <participants group_id="P4" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Number of Subjects Randomized Not Dosed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Number of Subjects in the Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="62"/>
                <participants group_id="P3" count="55"/>
                <participants group_id="P4" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Number of Subjects in the mITT Population</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="53"/>
                <participants group_id="P4" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="59"/>
                <participants group_id="P3" count="52"/>
                <participants group_id="P4" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized not dosed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Molnupiravir 200 mg</title>
          <description>molnupiravir twice daily (BID) for 5 days</description>
        </group>
        <group group_id="B2">
          <title>Molnupiravir 400 mg</title>
          <description>molnupiravir twice daily (BID) for 5 days</description>
        </group>
        <group group_id="B3">
          <title>Molnupiravir 800 mg</title>
          <description>molnupiravir twice daily (BID) for 5 days</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Placebo twice daily (BID) for 5 days</description>
        </group>
        <group group_id="B5">
          <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="23"/>
            <count group_id="B2" value="62"/>
            <count group_id="B3" value="55"/>
            <count group_id="B4" value="62"/>
            <count group_id="B5" value="202"/>
          </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="36.5" spread="15.34"/>
                    <measurement group_id="B2" value="42.4" spread="14.88"/>
                    <measurement group_id="B3" value="42.2" spread="14.36"/>
                    <measurement group_id="B4" value="39.7" spread="14.10"/>
                    <measurement group_id="B5" value="40.8" spread="14.57"/>
                  </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="11"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="34"/>
                    <measurement group_id="B5" value="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="98"/>
                  </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="7"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="115"/>
                  </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="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="54"/>
                    <measurement group_id="B5" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs</title>
        <description>The number of participants until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test.&#xD;
Non detectable defined as &quot;a viral load below the limit of quantification</description>
        <time_frame>28 days</time_frame>
        <population>mITT - modified Intent to Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>Molnupiravir 200 mg</title>
            <description>molnupiravir twice daily (BID) for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Molnupiravir 400 mg</title>
            <description>molnupiravir twice daily (BID) for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Molnupiravir 800 mg</title>
            <description>molnupiravir twice daily (BID) for 5 days</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo twice daily (BID) for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs</title>
          <description>The number of participants until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test.&#xD;
Non detectable defined as &quot;a viral load below the limit of quantification</description>
          <population>mITT - modified Intent to Treat Population</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="23"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number (%) with response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="49"/>
                    <measurement group_id="O4" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number (%) censored</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5551</p_value>
            <method>Log Rank</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7270</p_value>
            <method>Log Rank</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0128</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Clearance of SARS-CoV-2 in Nasopharyngeal Swabs</title>
        <description>The distribution of days until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test.&#xD;
Non detectable defined as &quot;a viral load below the limit of quantification</description>
        <time_frame>28 days</time_frame>
        <population>mITT - modified Intent to Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>Molnupiravir 200 mg</title>
            <description>molnupiravir twice daily (BID) for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Molnupiravir 400 mg</title>
            <description>molnupiravir twice daily (BID) for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Molnupiravir 800 mg</title>
            <description>molnupiravir twice daily (BID) for 5 days</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo twice daily (BID) for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Clearance of SARS-CoV-2 in Nasopharyngeal Swabs</title>
          <description>The distribution of days until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test.&#xD;
Non detectable defined as &quot;a viral load below the limit of quantification</description>
          <population>mITT - modified Intent to Treat Population</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="23"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.0" lower_limit="15.0" upper_limit="28.0"/>
                    <measurement group_id="O2" value="27.0" lower_limit="15.0" upper_limit="28.0"/>
                    <measurement group_id="O3" value="14.0" lower_limit="13.0" upper_limit="14.0"/>
                    <measurement group_id="O4" value="15.0" lower_limit="15.0" upper_limit="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events (AEs) Grade 3 or Higher or Leading to Discontinuation of Study Treatment</title>
        <description>1) any AEs leading to early discontinuation of blinded treatment (active or placebo), 2) study drug-related discontinuation of treatment, 3) new grade 3 or higher AEs (not already present at baseline), and 4) study drug-related new grade 3 or higher AEs.</description>
        <time_frame>28 days</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Molnupiravir 200 mg</title>
            <description>molnupiravir twice daily (BID) for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Molnupiravir 400 mg</title>
            <description>molnupiravir twice daily (BID) for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Molnupiravir 800 mg</title>
            <description>molnupiravir twice daily (BID) for 5 days</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo twice daily (BID) for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) Grade 3 or Higher or Leading to Discontinuation of Study Treatment</title>
          <description>1) any AEs leading to early discontinuation of blinded treatment (active or placebo), 2) study drug-related discontinuation of treatment, 3) new grade 3 or higher AEs (not already present at baseline), and 4) study drug-related new grade 3 or higher AEs.</description>
          <population>Safety population</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="23"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs leading to early discontinuation of blinded treatment (active or placebo)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs leading to study drug-related discontinuation of treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>new grade 3 or higher AEs (not already present at baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>study drug-related new grade 3 or higher AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Adverse Events (AEs), Grade 2 or Higher</title>
        <description>Measure the safety and tolerability of EIDD-2801 by estimating the occurrence of Grade 2 or higher AE and drug related AEs.</description>
        <time_frame>28 days</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Molnupiravir 200 mg</title>
            <description>EIDD-2801 twice daily (BID) for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Molnupiravir 400 mg</title>
            <description>EIDD-2801 twice daily (BID) for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Molnupiravir 800 mg</title>
            <description>EIDD-2801 twice daily (BID) for 5 days</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo twice daily (BID) for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Adverse Events (AEs), Grade 2 or Higher</title>
          <description>Measure the safety and tolerability of EIDD-2801 by estimating the occurrence of Grade 2 or higher AE and drug related AEs.</description>
          <population>Safety population</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="23"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Molnupiravir 200 mg</title>
          <description>EIDD-2801 twice daily (BID) for 5 days</description>
        </group>
        <group group_id="E2">
          <title>Molnupiravir 400 mg</title>
          <description>EIDD-2801 twice daily (BID) for 5 days</description>
        </group>
        <group group_id="E3">
          <title>Molnupiravir 800 mg</title>
          <description>EIDD-2801 twice daily (BID) for 5 days</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Placebo twice daily (BID) for 5 days</description>
        </group>
      </group_list>
      <serious_events>
        <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="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="4" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="62"/>
              </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>PI is requested to obtain written consent from the Sponsor before anything relating to the study can be published.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Wendy Painter</name_or_title>
      <organization>Ridgeback Biotherapeutics</organization>
      <phone>786-687-2495</phone>
      <email>EIDD2801@ridgebackbio.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/NCT04405570
org study id: EIDD-2801-2003
nct id: NCT04405570
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare
      the safety, tolerability, and antiviral activity of EIDD-2801 (molnupiravir) versus placebo
      as measured by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19.
This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare
      the safety, tolerability, and antiviral activity of molnupiravir versus placebo as measured
      by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19. The study
      was a multicenter trial that was conducted in the United States.

      In this study, 204 participants were randomized and 202 received molnupiravir or placebo
      orally twice a day (BID) for 5 days. The study enrolled participants in 5 parts with each
      part evaluating molnupiravir doses of either 200 mg BID, 400 mg BID, or 800 mg BID. Doses
      were chosen based on emerging virology and safety data from this and ongoing studies. New
      dose groups were started after the selected dose had been studied for safety in a Phase 1
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs
time frame: 28 days
description: The number of participants until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test.
Non detectable defined as "a viral load below the limit of quantification
measure: Time to Clearance of SARS-CoV-2 in Nasopharyngeal Swabs
time frame: 28 days
description: The distribution of days until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test.
Non detectable defined as "a viral load below the limit of quantification
measure: Number of Participants With Adverse Events (AEs) Grade 3 or Higher or Leading to Discontinuation of Study Treatment
time frame: 28 days
description: 1) any AEs leading to early discontinuation of blinded treatment (active or placebo), 2) study drug-related discontinuation of treatment, 3) new grade 3 or higher AEs (not already present at baseline), and 4) study drug-related new grade 3 or higher AEs.
measure: Number of Participants With Any Adverse Events (AEs), Grade 2 or Higher
time frame: 28 days
description: Measure the safety and tolerability of EIDD-2801 by estimating the occurrence of Grade 2 or higher AE and drug related AEs.
arm group label: Molnupiravir 200 mg
arm group type: Experimental
description: Molnupiravir 200 mg, twice daily (BID) for 5 days
arm group label: Molnupiravir 400 mg
arm group type: Experimental
description: Molnupiravir 400 mg, twice daily (BID) for 5 days
arm group label: Molnupiravir 800 mg
arm group type: Experimental
description: Molnupiravir 800 mg, twice daily (BID) for 5 days
arm group label: Placebo (PBO) twice daily (BID) for 5 days
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Molnupiravir 200 mg
description: Oral capsule of molnupiravir
arm group label: Molnupiravir 200 mg
intervention type: Drug
intervention name: Molnupiravir 400 mg
description: Oral capsule of molnupiravir
arm group label: Molnupiravir 400 mg
intervention type: Drug
intervention name: Molnupiravir 800 mg
description: Oral capsule of molnupiravir
arm group label: Molnupiravir 800 mg
intervention type: Drug
intervention name: Placebo (PBO)
description: placebo oral capsule
arm group label: Placebo (PBO) twice daily (BID) for 5 days
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://doi.org/10.46621/UYGR2287
description: Benson et al, 2020. Society of Family Planning interim clinical recommendations
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Molnupiravir
sharing ipd: No
ipd description: There is not a plan to make IPD available.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 