<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/NCT04405739</url>
  </required_header>
  <id_info>
    <org_study_id>EIDD-2801-2004</org_study_id>
    <nct_id>NCT04405739</nct_id>
  </id_info>
  <brief_title>The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID)</brief_title>
  <official_title>The Safety of EIDD-2801 and Its Effect on Viral Shedding of SARS-CoV-2</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>
      Designed as a multi-center, randomized, double-blind, placebo-controlled study to assess the&#xD;
      efficacy and safety of EIDD-2801 on SARS-CoV-2 Virus Shedding in Newly Hospitalized Adults&#xD;
      with polymerase chain reaction (PCR)-Confirmed COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 2a randomized, placebo-controlled, double-blinded clinical trial of EIDD-2801 (also&#xD;
      known as MK 4482) in adult men and women who have tested positive for severe acute&#xD;
      respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection by polymerase chain reaction (PCR)&#xD;
      test within 6 days (144 hours) prior to randomization and are hospitalized with a diagnosis&#xD;
      of COVID-19. Rapid enrollment and treatment will be initiated such that the first dose of&#xD;
      EIDD-2801 or placebo will be administered as soon as possible and within 7 days of onset of&#xD;
      symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Actual">February 21, 2022</completion_date>
  <primary_completion_date type="Actual">February 21, 2022</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 That Achieve Virologic Clearance After Oral Administration of EIDD-2801</measure>
    <time_frame>28 days</time_frame>
    <description>Achievement of undetectable (below the limit of detection of the assay) SARS-CoV-2 RNA by day 5 in NP swabs by quantitative Polymerase Chain Reaction (qPCR) in the Efficacy Analysis Set (EAS). The Efficacy Analysis Set consisted of all participants treated with at least on dose of study drug and with at least 1 post baseline assessment of SARS-CoV-2 RNA in NP swabs by qPCR</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Any Serious Adverse Events(SAEs) as Assessed by DAIDS</measure>
    <time_frame>28 days</time_frame>
    <description>Incidence of Serious Adverse Events in subjects receiving EIDD-2801 as assessed by DAIDS in the Safety Population, defined as all participants treated with at least one dose of study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Any Adverse Events(AEs) as Assessed by DAIDS</measure>
    <time_frame>28 days</time_frame>
    <description>Incidence of Adverse Events in subjects receiving EIDD-2801 as assessed by DAIDS</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>EIDD-2801 twice daily (BID) for 5 days</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EIDD-2801 orally twice daily (BID) for 5 days at Dose A, Dose B, Dose C, Dose D, Dose E, Dose F</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>
    <description>Placebo (PBO) orally twice daily (BID) for 5 days matched for size and appearance to active IP</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EIDD-2801</intervention_name>
    <description>Oral capsule of EIDD-2801</description>
    <arm_group_label>EIDD-2801 twice daily (BID) for 5 days</arm_group_label>
    <other_name>molnupiravir</other_name>
    <other_name>MK-4482</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral placebo capsule</description>
    <arm_group_label>placebo (PBO) twice daily (BID) for 5 days</arm_group_label>
    <other_name>PBO</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Has COVID-19 disease, defined by having one or more of the following new symptoms and&#xD;
             signs (within 7 days):&#xD;
&#xD;
               -  Fevers OR&#xD;
&#xD;
               -  At least one of the following symptoms: cough, shortness of breath, respiratory&#xD;
                  rate ≥ 20, radiographic evidence of pneumonia OR&#xD;
&#xD;
               -  Anosmia OR&#xD;
&#xD;
               -  other clinical symptoms or signs of COVID-19 that are not otherwise explained by&#xD;
                  comorbidities or co-diagnoses&#xD;
&#xD;
          2. PCR+ test for SARS-CoV-2.&#xD;
&#xD;
          3. Has new signs or symptoms of COVID-19 that began ≤7 days of anticipated first dose of&#xD;
             study drug.&#xD;
&#xD;
          4. Persons ≥18 years old.&#xD;
&#xD;
          5. at the time of first dose.&#xD;
&#xD;
        5. ≥18 years old.&#xD;
&#xD;
        6. Is willing and able to comply with all study procedures including providing informed&#xD;
        consent, collection of virology samples, and any safety tests that are not included as part&#xD;
        of standard of care (SOC).&#xD;
&#xD;
        7. Is willing and able to take oral medications, and is anticipated to be able to take the&#xD;
        full course of 5 days of study drug.&#xD;
&#xD;
        Pregnancy and Contraception: In nonclinical developmental and reproductive toxicity&#xD;
        studies, developmental toxicity including malformation was observed in fetuses from&#xD;
        pregnant animals dosed with EIDD-2801 (MK 4482). Therefore, treatment with EIDD-2801 is&#xD;
        contraindicated in women who are pregnant or nursing and in the male partners of women who&#xD;
        are pregnant. Extreme care must be taken to avoid pregnancy during the study and for 4 days&#xD;
        after completion of EIDD 2801 dosing in female participants and for 4 days after completion&#xD;
        of EIDD-2801 dosing in female partners of male participants.&#xD;
&#xD;
        8. A female participant is eligible to participate if she is not pregnant or breastfeeding&#xD;
        and at least one of the following conditions applies:&#xD;
&#xD;
          -  Is not a woman of childbearing potential (WOCBP) OR&#xD;
&#xD;
          -  Is 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 method), or&#xD;
             be abstinent from heterosexual intercourse as their preferred and usual lifestyle&#xD;
             (abstinent on a long-term and persistent basis), as described in Appendix 2 during the&#xD;
             intervention period and for at least 4 days after the last dose of study intervention.&#xD;
             The investigator should evaluate the potential for contraceptive method failure (ie,&#xD;
             noncompliance, recently initiated) in relationship to the first dose of study&#xD;
             intervention.&#xD;
&#xD;
          -  A WOCBP must have a negative highly sensitive pregnancy test (serum test is required)&#xD;
             within 24 hours before the first dose of study intervention.&#xD;
&#xD;
          -  Additional requirements for pregnancy testing during and after study intervention are&#xD;
             located in Section 4.4.&#xD;
&#xD;
          -  The investigator is responsible for review of medical history, menstrual history, and&#xD;
             recent sexual activity to decrease the risk for inclusion of a woman with an early&#xD;
             undetected pregnancy.&#xD;
&#xD;
          -  Contraceptive use by women should be consistent with local regulations regarding the&#xD;
             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 contraceptives&#xD;
             must not be started to fulfill the contraceptive requirement of this study at any time&#xD;
             during participant's hospitalization. If contraceptives are interrupted as standard of&#xD;
             care management of COVID-19 patients and resumed at a later time point, such as at&#xD;
             hospital discharge, then abstinence must be practiced for the defined period of&#xD;
             back-up contraception per the contraceptive product labeling. After this period,&#xD;
             contraceptive use must adhere to Appendix 2.&#xD;
&#xD;
             9. Male participants are eligible to participate if they agree to the following during&#xD;
             the intervention period and for at least 4 days after the last dose of study&#xD;
             intervention:&#xD;
&#xD;
          -  Be abstinent from heterosexual intercourse as their preferred and usual lifestyle&#xD;
             (abstinent on a long term and persistent basis) and agree to remain abstinent OR&#xD;
&#xD;
          -  Must agree to use contraception unless confirmed to be azoospermic (vasectomized or&#xD;
             secondary to medical cause [Appendix 2]) as detailed below:&#xD;
&#xD;
        Agree to use a male condom plus partner use of an additional contraceptive method when&#xD;
        having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men&#xD;
        with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal&#xD;
        intercourse or use a male condom during each episode of penile-vaginal penetration.&#xD;
&#xD;
        • Contraceptive use by men should be consistent with local regulations regarding the&#xD;
        methods of contraception for those participating in clinical studies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Is anticipated to require ICU admission for mechanical ventilation within 24 hours of&#xD;
             enrollment.&#xD;
&#xD;
          2. Requires more than 6 liters/minute of oxygen to maintain O2 saturation above 95%&#xD;
&#xD;
          3. Is not expected to survive longer than 24 hours.&#xD;
&#xD;
          4. Has a platelet count less than 100,000/µL, hemoglobin less than 9 g/dL, or has a&#xD;
             disorder of the hematologic system including anemic disorder or other blood dyscrasia,&#xD;
             cancer of the hematologic system, history of bone marrow transplant, or other&#xD;
             significant hematologic disease.&#xD;
&#xD;
          5. Women who are pregnant or breastfeeding.&#xD;
&#xD;
          6. Is experiencing DAIDS AE grading scale grade 4 baseline medical conditions or&#xD;
             laboratory abnormalities..&#xD;
&#xD;
          7. Has received a vaccine for COVID-19 prior to enrollment, or plans to receive a vaccine&#xD;
             for COVID-19 before the end-of-study visit.&#xD;
&#xD;
          8. Has received an experimental antiviral treatment for COVID-19 prior to enrollment.&#xD;
&#xD;
          9. Has received convalescent plasma or other monoclonal antibodies prior to enrollment..&#xD;
&#xD;
         10. Is participating in another clinical study that involves pharmacologic intervention or&#xD;
             has participated in another study within 30 days of 5 half-lives of the&#xD;
             investigational agent (observational study participation is permitted).&#xD;
&#xD;
         11. In the opinion of the investigator, has end-organ disease as a result of relevant&#xD;
             comorbidities: chronic kidney disease (reduced glomerular filtration rate (GFR) &lt;30&#xD;
             mL/min by the Modification of Diet in Renal Disease (MDRD) study equation prior to&#xD;
             COVID-19 symptom onset), decompensated chronic liver disease or cirrhosis,&#xD;
             decompensated congestive heart failure, active peripheral vascular disease including&#xD;
             active diabetic ulcers, chronic pulmonary disease prior to COVID-19 symptom onset&#xD;
             requiring bilevel positive airway pressure (BiPAP) or &gt;4 L/min supplemental oxygen at&#xD;
             baseline; if using ≤4 L/min supplemental oxygen at baseline, consultation with and&#xD;
             approval of the sponsor is required prior to enrollment.&#xD;
&#xD;
         12. Has a diagnosis of cancer that is not in remission. Noninvasive cancers, such as basal&#xD;
             and squamous cell carcinoma or history of in situ tumors are allowed at the discretion&#xD;
             of the investigator after discussion with the sponsor.&#xD;
&#xD;
         13. Has received an organ transplantation.&#xD;
&#xD;
         14. Has received a bone marrow transplantation.&#xD;
&#xD;
         15. Has been on immunosuppressive medications within one month prior to enrollment.&#xD;
&#xD;
         16. Has any condition that would, in the opinion of the investigator, put the participant&#xD;
             at increased risk for participation in a clinical trial.&#xD;
&#xD;
         17. Has known active hepatitis C (HCV RNA positive), active hepatitis B (hepatitis B&#xD;
             surface antigen positive), or HIV (ELISA and confirmatory Western blotting). New&#xD;
             screening tests not required.&#xD;
&#xD;
         18. Is currently taking nucleos(t)ide analogues for HIV or Hepatitis B, or for their&#xD;
             prevention, within 30 days of study enrollment.&#xD;
&#xD;
         19. Is currently taking systemic corticosteroids other than replacement doses, or for&#xD;
             treatment of COVID-19.&#xD;
&#xD;
         20. Has a Body Mass Index (BMI) &gt;50 kg/m2.&#xD;
&#xD;
         21. Is anticipated to require surgery within 48 hours after hospital admission.&#xD;
&#xD;
         22. Is anticipated to have a nothing per mouth (NPO) order placed within 48 hours after&#xD;
             hospital admission that is expected to last for &gt; 24 hours.&#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>Ashwin Balagopal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ronald Reagan UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095-8358</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cook County Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Christ Medical Center</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Lutheran General Hospital</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner LSU Health Shreveport Academic Medical Center</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Howard County General Hospital</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</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>February 16, 2023</results_first_submitted>
  <results_first_submitted_qc>March 22, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 23, 2023</results_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Molnupiravir</mesh_term>
  </intervention_browse>
  <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>May 18, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT04405739/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>March 24, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT04405739/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="4"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4">Molnupiravir 200-mg arm includes 1 participant randomized to molnupiravir 300 mg under protocol version 2</participants>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="22"/>
                <participants group_id="P4" count="18"/>
              </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="6"/>
              </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="0"/>
                <participants group_id="P4" count="0"/>
              </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="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
              </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="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</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>Transferred to rehab</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pt. refused IP after 1 dose</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </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>molnupiravir 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="4"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="25"/>
            <count group_id="B4" value="24"/>
            <count group_id="B5" value="71"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="24"/>
                    <count group_id="B5" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.3" spread="9.07"/>
                    <measurement group_id="B2" value="52.1" spread="16.37"/>
                    <measurement group_id="B3" value="53.5" spread="15.42"/>
                    <measurement group_id="B4" value="57.1" spread="14.43"/>
                    <measurement group_id="B5" value="54.5" spread="14.93"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="24"/>
                    <count group_id="B5" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="43"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="24"/>
                    <count group_id="B5" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="41"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="24"/>
                    <count group_id="B5" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="24"/>
                    <count group_id="B5" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="24"/>
                    <count group_id="B5" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="24"/>
                    <count group_id="B5" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown/Not reported</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="24"/>
                    <count group_id="B5" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="24"/>
                    <count group_id="B5" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="24"/>
                    <count group_id="B5" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="25"/>
                    <count group_id="B4" value="24"/>
                    <count group_id="B5" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
        </measure>
        <measure>
          <title>SARS-CoV-2 RNA by qPCR in NP Swabs</title>
          <population>Baseline SARS-CoV-2 values were missing for participants for whom the qPCR test value fell below the lower limit of quantification.</population>
          <units>log 10 copies/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="4"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="23"/>
                    <count group_id="B4" value="20"/>
                    <count group_id="B5" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.45" spread="1.655"/>
                    <measurement group_id="B2" value="4.83" spread="1.487"/>
                    <measurement group_id="B3" value="4.77" spread="1.442"/>
                    <measurement group_id="B4" value="5.07" spread="1.553"/>
                    <measurement group_id="B5" value="5.24" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants That Achieve Virologic Clearance After Oral Administration of EIDD-2801</title>
        <description>Achievement of undetectable (below the limit of detection of the assay) SARS-CoV-2 RNA by day 5 in NP swabs by quantitative Polymerase Chain Reaction (qPCR) in the Efficacy Analysis Set (EAS). The Efficacy Analysis Set consisted of all participants treated with at least on dose of study drug and with at least 1 post baseline assessment of SARS-CoV-2 RNA in NP swabs by qPCR</description>
        <time_frame>28 days</time_frame>
        <population>EAS 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 That Achieve Virologic Clearance After Oral Administration of EIDD-2801</title>
          <description>Achievement of undetectable (below the limit of detection of the assay) SARS-CoV-2 RNA by day 5 in NP swabs by quantitative Polymerase Chain Reaction (qPCR) in the Efficacy Analysis Set (EAS). The Efficacy Analysis Set consisted of all participants treated with at least on dose of study drug and with at least 1 post baseline assessment of SARS-CoV-2 RNA in NP swabs by qPCR</description>
          <population>EAS 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="4"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Any Serious Adverse Events(SAEs) as Assessed by DAIDS</title>
        <description>Incidence of Serious Adverse Events in subjects receiving EIDD-2801 as assessed by DAIDS in the Safety Population, defined as all participants treated with at least one dose of study drug.</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 Any Serious Adverse Events(SAEs) as Assessed by DAIDS</title>
          <description>Incidence of Serious Adverse Events in subjects receiving EIDD-2801 as assessed by DAIDS in the Safety Population, defined as all participants treated with at least one dose of study drug.</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="4"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Any Adverse Events(AEs) as Assessed by DAIDS</title>
        <description>Incidence of Adverse Events in subjects receiving EIDD-2801 as assessed by DAIDS</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 Any Adverse Events(AEs) as Assessed by DAIDS</title>
          <description>Incidence of Adverse Events in subjects receiving EIDD-2801 as assessed by DAIDS</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="4"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 days</time_frame>
      <desc>Adverse event is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy/intervention) even if the event is not considered to be related to the study. All AEs experienced by participants will be collected and reported from the first dose of EIDD 2801, throughout the study, and will be followed for 28 days unless related to the investigational agent.</desc>
      <group_list>
        <group group_id="E1">
          <title>Molnupiravir 200 mg</title>
          <description>molnupiravir twice daily (BID) for 5 days</description>
        </group>
        <group group_id="E2">
          <title>Molnupiravir 400 mg</title>
          <description>molnupiravir twice daily (BID) for 5 days</description>
        </group>
        <group group_id="E3">
          <title>Molnupiravir 800 mg</title>
          <description>molnupiravir 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_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Non-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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </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="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypovolemic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Non-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="4"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="18"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ageusia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Alcohol use disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Drug dependence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Nail discoloration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </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>Wendy Painter, MD, MPH</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/NCT04405739
org study id: EIDD-2801-2004
nct id: NCT04405739
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
Designed as a multi-center, randomized, double-blind, placebo-controlled study to assess the
      efficacy and safety of EIDD-2801 on SARS-CoV-2 Virus Shedding in Newly Hospitalized Adults
      with polymerase chain reaction (PCR)-Confirmed COVID-19.
Phase 2a randomized, placebo-controlled, double-blinded clinical trial of EIDD-2801 (also
      known as MK 4482) in adult men and women who have tested positive for severe acute
      respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection by polymerase chain reaction (PCR)
      test within 6 days (144 hours) prior to randomization and are hospitalized with a diagnosis
      of COVID-19. Rapid enrollment and treatment will be initiated such that the first dose of
      EIDD-2801 or placebo will be administered as soon as possible and within 7 days of onset of
      symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants That Achieve Virologic Clearance After Oral Administration of EIDD-2801
time frame: 28 days
description: Achievement of undetectable (below the limit of detection of the assay) SARS-CoV-2 RNA by day 5 in NP swabs by quantitative Polymerase Chain Reaction (qPCR) in the Efficacy Analysis Set (EAS). The Efficacy Analysis Set consisted of all participants treated with at least on dose of study drug and with at least 1 post baseline assessment of SARS-CoV-2 RNA in NP swabs by qPCR
measure: Number of Participants With Any Serious Adverse Events(SAEs) as Assessed by DAIDS
time frame: 28 days
description: Incidence of Serious Adverse Events in subjects receiving EIDD-2801 as assessed by DAIDS in the Safety Population, defined as all participants treated with at least one dose of study drug.
measure: Number of Participants With Any Adverse Events(AEs) as Assessed by DAIDS
time frame: 28 days
description: Incidence of Adverse Events in subjects receiving EIDD-2801 as assessed by DAIDS
arm group label: EIDD-2801 twice daily (BID) for 5 days
arm group type: Experimental
description: EIDD-2801 orally twice daily (BID) for 5 days at Dose A, Dose B, Dose C, Dose D, Dose E, Dose F
arm group label: placebo (PBO) twice daily (BID) for 5 days
arm group type: Placebo Comparator
description: Placebo (PBO) orally twice daily (BID) for 5 days matched for size and appearance to active IP
intervention type: Drug
intervention name: EIDD-2801
description: Oral capsule of EIDD-2801
arm group label: EIDD-2801 twice daily (BID) for 5 days
other name: molnupiravir
other name: MK-4482
intervention type: Drug
intervention name: Placebo
description: Oral placebo capsule
arm group label: placebo (PBO) twice daily (BID) for 5 days
other name: PBO
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ashwin Balagopal, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Molnupiravir
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 