<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/NCT04425629</url>
  </required_header>
  <id_info>
    <org_study_id>R10933-10987-COV-2067</org_study_id>
    <secondary_id>2020-003690-21</secondary_id>
    <nct_id>NCT04425629</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19</brief_title>
  <official_title>A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Regeneron Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase 1&#xD;
&#xD;
        -  To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo&#xD;
&#xD;
        -  To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in&#xD;
           reducing viral load of SARS-CoV-2&#xD;
&#xD;
      Phase 2&#xD;
&#xD;
      • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing&#xD;
      viral load of SARS-CoV-2&#xD;
&#xD;
      Phase 3&#xD;
&#xD;
        -  Cohort 1 (≥18 Years Old, Not Pregnant at Randomization)&#xD;
&#xD;
           • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as&#xD;
           measured by COVID-19-related hospitalizations or all-cause death&#xD;
&#xD;
        -  Cohort 2 (&lt;18 Years Old, Not Pregnant at Randomization)&#xD;
&#xD;
             -  To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo&#xD;
&#xD;
             -  To further characterize the concentrations of REGN10933 and REGN10987 in serum over&#xD;
                time&#xD;
&#xD;
        -  Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of&#xD;
           REGN10933+REGN10987&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Emerging SARS-CoV-2 variants impacting susceptibility to study drug&#xD;
  </why_stopped>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Actual">June 9, 2022</completion_date>
  <primary_completion_date type="Actual">January 21, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Phase 1/Phase 2/Phase 3</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with treatment-emergent serious adverse events (SAEs)</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Primary:&#xD;
Phase 1, Phase 3 (Cohort 2 and Cohort 3)&#xD;
Secondary:&#xD;
Phase 2, Phase 3 (Cohort 1)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients with infusion-related reactions</measure>
    <time_frame>Through Day 4</time_frame>
    <description>Primary:&#xD;
Phase 1, Phase 3 (Cohort 2 and Cohort 3)&#xD;
Secondary:&#xD;
Phase 2, Phase 3 (Cohort 1)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients with hypersensitivity reactions</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Primary:&#xD;
Phase 1, Phase 3 (Cohort 2 and Cohort 3)&#xD;
Secondary:&#xD;
Phase 2, Phase 3 (Cohort 1)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by quantitative reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples</measure>
    <time_frame>Baseline up to Day 7</time_frame>
    <description>Primary:&#xD;
Phase 1, Phase 2&#xD;
Secondary:&#xD;
Phase 3 (Cohort 1, for patients enrolled prior to protocol amendment 6 only), Phase 3 (Cohort 2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients with at least one (≥1) COVID-19-related hospitalization or all-cause death</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Primary:&#xD;
Phase 3 (Cohort 1)&#xD;
Secondary:&#xD;
Phase 3 (Cohort 2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of REGN10933 in serum over time</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Primary:&#xD;
Phase 3 (Cohort 2)&#xD;
Secondary:&#xD;
Phase 1, Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of REGN10987 in serum over time</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Primary:&#xD;
Phase 3 (Cohort 2)&#xD;
Secondary:&#xD;
Phase 1, Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in saliva samples</measure>
    <time_frame>Baseline up to Day 22</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in nasal swab samples</measure>
    <time_frame>Baseline up to Day 22</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to negative RT-qPCR in nasopharyngeal swabs with no subsequent positive RT-qPCR</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 2 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in viral load at each visit, as measured by RT-qPCR in nasopharyngeal swabs</measure>
    <time_frame>Baseline up to Day 29</time_frame>
    <description>Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in viral load at each visit, as measured by RT-qPCR in saliva samples</measure>
    <time_frame>Baseline up to Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in viral load at each visit, as measured by RT-qPCR in nasal swabs</measure>
    <time_frame>Baseline up to Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of RT-qPCR results over time between different sample types (NP, nasal, and saliva)</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance of RT-qPCR results over time between different sample types (NP, nasal, and saliva)</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-weighted average change from baseline in viral load (log10 copies/mL) from day 1 to post-baseline study days</measure>
    <time_frame>Day 1 to Day 29</time_frame>
    <description>Phase 1, Phase 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with ≥1 COVID-19-related medically-attended visit</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1, Phase 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with ≥2 COVID-19-related medically-attended visit</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of COVID-19-related medically-attended visits</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants admitted to a hospital due to COVID-19</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1, Phase 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with ≥1 outpatient or telemedicine visit due to COVID-19</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1, Phase 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10933</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10987</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of PK parameter: Time to Cmax (tmax) for REGN10933</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of PK parameter: Time to Cmax (tmax) for REGN10987</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of PK parameter: Area Under the Curve (AUC) computed from time zero to the time of the last positive concentration (AUClast) for REGN10933</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as measured by anti-drug (ADA) to REGN10933</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1, Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as measured by ADA to REGN10987</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 1, Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as measured by neutralizing antibodies (NAbs) to REGN10933</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as measured by NAbs to REGN10987</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with high viral load at each visit</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 2 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with viral loads below the limit of detection at each visit</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 2 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with viral loads below the lower limit of quantitation at each visit</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 2 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 2, Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants requiring mechanical ventilation due to COVID-19</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 2, Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days of hospitalization due to COVID-19</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 2, Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with all-cause mortality</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 2 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first onset of symptoms consistent with COVID-19 (asymptomatic cohort only)</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Phase 2 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of symptoms consistent with COVID-19</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Phase 2 Only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with ≥1 COVID-19-related hospitalization or all-cause death</measure>
    <time_frame>From Day 4 Through Day 29</time_frame>
    <description>Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to COVID-19 symptoms resolution</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 3 (Cohort 1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with ≥1 COVID-19-related hospitalization, emergency room visit, or all-cause death</measure>
    <time_frame>Through day 29</time_frame>
    <description>Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with (≥1) COVID-19-related medically-attended visit or all-cause death</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with ≥1 COVID-19-related medically-attended visit by type of visit</measure>
    <time_frame>Through day 29</time_frame>
    <description>Phase 3 (Cohort 1 and Cohort 2)&#xD;
Type of visit defined as hospitalization, emergency room, urgent care, and/or physician's office/telemedicine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of patients with ≥1 COVID-19-related hospitalization or all-cause death</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of patients with ≥1 COVID-19-related hospitalization, emergency room visit, or all-cause death</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of patients with ≥1 COVID-19-related medically-attended visit or all-cause death</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants requiring supplemental oxygen due to COVID-19</measure>
    <time_frame>Through Day 29</time_frame>
    <description>Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to all-cause death</measure>
    <time_frame>Through Day 169</time_frame>
    <description>Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death</measure>
    <time_frame>By Day 29, Day 120, and Day 169</time_frame>
    <description>Phase 3 (Cohort 1 and Cohort 2)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10078</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>casirivimab+imdevimab low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose or body-weight equivalent for those under 18 years of age.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>casirivimab+imdevimab combination therapy</intervention_name>
    <description>Administered intravenously (IV) single dose</description>
    <arm_group_label>casirivimab+imdevimab low dose</arm_group_label>
    <other_name>REGN-COV2</other_name>
    <other_name>REGN10933</other_name>
    <other_name>REGN10987</other_name>
    <other_name>REGEN-COV™</other_name>
    <other_name>Ronapreve™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Has SARS-CoV-2-positive diagnostic test (from a sample collected ≤72 hours prior to&#xD;
             randomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular&#xD;
             diagnostic assay, and an appropriate sample such as nasopharyngeal [NP], nasal,&#xD;
             oropharyngeal [OP], or saliva)&#xD;
&#xD;
          -  Has symptoms consistent with COVID-19, as determined by the investigator, with onset&#xD;
             ≤7 days before randomization&#xD;
&#xD;
          -  Maintains O2 saturation ≥93% on room air&#xD;
&#xD;
          -  Is able to understand and complete study-related questionnaires (patients aged ≥12&#xD;
             years only)&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized&#xD;
             (inpatient) for any reason at randomization&#xD;
&#xD;
          -  Has participated, or is participating, in a clinical research study evaluating&#xD;
             COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), or&#xD;
             intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the&#xD;
             investigational product (whichever is longer) prior to the screening visit&#xD;
&#xD;
          -  Prior, current, or planned future use of any of the following treatments: COVID-19&#xD;
             convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), IVIG (any&#xD;
             indication), systemic corticosteroids (any indication), or COVID-19 treatments&#xD;
             (authorized, approved, or investigational)&#xD;
&#xD;
          -  Prior use (prior to randomization), current use (at randomization) or planned use&#xD;
             (within 90 days of study drug administration or per current CDC recommendations, as&#xD;
             applicable) of any authorized or approved vaccine for COVID-19&#xD;
&#xD;
          -  Has participated, is participating or plans to participate in a clinical research&#xD;
             study evaluation any authorized, approved or investigational vaccine for COVID-19&#xD;
&#xD;
        NOTE: Other Protocol defined Inclusion/Exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Canoga Park</city>
        <state>California</state>
        <zip>91303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>La Palma</city>
        <state>California</state>
        <zip>90623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 2</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 3</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Montclair</city>
        <state>California</state>
        <zip>91763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Rolling Hills Estates</city>
        <state>California</state>
        <zip>90274</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33487</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Fort Pierce</city>
        <state>Florida</state>
        <zip>34982</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33010</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Loxahatchee Groves</city>
        <state>Florida</state>
        <zip>33470</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
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        <state>Florida</state>
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        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 2</name>
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        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33130</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33184</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33705</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Marietta</city>
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        <zip>30060</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 1</name>
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        <zip>60515</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site 2</name>
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        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>60515</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>50010-3014</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Louisiana</state>
        <zip>70114</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Louisiana</state>
        <zip>71118</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>21201</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>89109</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>07450</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>07666</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>87505</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>10451</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>New York</state>
        <zip>11432</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10025</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10037</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>28209</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>27710</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>28401</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>43215</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>45409</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>45432</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>19140</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>02903</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>29425</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>29325</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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  <location>
    <facility>
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        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>79109</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>78413</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>75246</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>75390</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>77004</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Texas</state>
        <zip>77008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Texas</state>
        <zip>77055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Texas</state>
        <zip>77057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Texas</state>
        <zip>77584</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Texas</state>
        <zip>75154</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>78215</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Texas</state>
        <zip>78217</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Texas</state>
        <zip>78249</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Texas</state>
        <zip>75708</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
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        <zip>98201</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44280</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44340</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Zapopan</city>
        <state>Jalisco</state>
        <zip>45070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64718</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>64710</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Merida</city>
        <state>Yucatan</state>
        <zip>97070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Chihuahua</city>
        <zip>31238</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Ciudad de Mexico</city>
        <zip>3100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Durango</city>
        <zip>34000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Mérida</city>
        <zip>97000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Veracruz</city>
        <zip>91900</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regeneron Study Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>021105</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
    <country>Romania</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Chile</country>
  </removed_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 26, 2022</last_update_submitted>
  <last_update_submitted_qc>July 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus disease 2019 (COVID-19)</keyword>
  <keyword>Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)</keyword>
  <keyword>coronavirus</keyword>
  <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>Casirivimab and imdevimab drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT04425629/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>January 20, 2023</submitted>
    <returned>February 17, 2023</returned>
    <submitted>March 14, 2023</submitted>
    <returned>April 10, 2023</returned>
    <submitted>May 3, 2023</submitted>
    <returned>June 1, 2023</returned>
    <submitted>June 26, 2023</submitted>
    <returned>July 21, 2023</returned>
    <submitted>August 14, 2023</submitted>
    <returned>September 7, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04425629
org study id: R10933-10987-COV-2067
secondary id: 2020-003690-21
nct id: NCT04425629
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Phase 1

        -  To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo

        -  To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in
           reducing viral load of SARS-CoV-2

      Phase 2

      • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing
      viral load of SARS-CoV-2

      Phase 3

        -  Cohort 1 (≥18 Years Old, Not Pregnant at Randomization)

           • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as
           measured by COVID-19-related hospitalizations or all-cause death

        -  Cohort 2 (<18 Years Old, Not Pregnant at Randomization)

             -  To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo

             -  To further characterize the concentrations of REGN10933 and REGN10987 in serum over
                time

        -  Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of
           REGN10933+REGN10987
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Phase 1/Phase 2/Phase 3
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients with treatment-emergent serious adverse events (SAEs)
time frame: Through Day 29
description: Primary:
Phase 1, Phase 3 (Cohort 2 and Cohort 3)
Secondary:
Phase 2, Phase 3 (Cohort 1)
measure: Proportion of patients with infusion-related reactions
time frame: Through Day 4
description: Primary:
Phase 1, Phase 3 (Cohort 2 and Cohort 3)
Secondary:
Phase 2, Phase 3 (Cohort 1)
measure: Proportion of patients with hypersensitivity reactions
time frame: Through Day 29
description: Primary:
Phase 1, Phase 3 (Cohort 2 and Cohort 3)
Secondary:
Phase 2, Phase 3 (Cohort 1)
measure: Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by quantitative reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples
time frame: Baseline up to Day 7
description: Primary:
Phase 1, Phase 2
Secondary:
Phase 3 (Cohort 1, for patients enrolled prior to protocol amendment 6 only), Phase 3 (Cohort 2)
measure: Proportion of patients with at least one (≥1) COVID-19-related hospitalization or all-cause death
time frame: Through Day 29
description: Primary:
Phase 3 (Cohort 1)
Secondary:
Phase 3 (Cohort 2)
measure: Concentration of REGN10933 in serum over time
time frame: Through Day 29
description: Primary:
Phase 3 (Cohort 2)
Secondary:
Phase 1, Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)
measure: Concentration of REGN10987 in serum over time
time frame: Through Day 29
description: Primary:
Phase 3 (Cohort 2)
Secondary:
Phase 1, Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)
measure: Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in saliva samples
time frame: Baseline up to Day 22
description: Phase 1 Only
measure: Time-weighted average change from baseline in viral load (log10 copies/mL), as measured by RT-qPCR in nasal swab samples
time frame: Baseline up to Day 22
description: Phase 1 Only
measure: Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples
time frame: Through Day 29
description: Phase 1 Only
measure: Time to negative RT-qPCR in nasopharyngeal swabs with no subsequent positive RT-qPCR
time frame: Through Day 29
description: Phase 2 Only
measure: Change from baseline in viral load at each visit, as measured by RT-qPCR in nasopharyngeal swabs
time frame: Baseline up to Day 29
description: Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 2)
measure: Change from baseline in viral load at each visit, as measured by RT-qPCR in saliva samples
time frame: Baseline up to Day 29
description: Phase 1 Only
measure: Change from baseline in viral load at each visit, as measured by RT-qPCR in nasal swabs
time frame: Baseline up to Day 29
description: Phase 1 Only
measure: Correlation of RT-qPCR results over time between different sample types (NP, nasal, and saliva)
time frame: Up to Day 29
description: Phase 1 Only
measure: Concordance of RT-qPCR results over time between different sample types (NP, nasal, and saliva)
time frame: Up to Day 29
description: Phase 1 Only
measure: Time-weighted average change from baseline in viral load (log10 copies/mL) from day 1 to post-baseline study days
time frame: Day 1 to Day 29
description: Phase 1, Phase 2
measure: Proportion of participants with ≥1 COVID-19-related medically-attended visit
time frame: Through Day 29
description: Phase 1, Phase 2
measure: Proportion of participants with ≥2 COVID-19-related medically-attended visit
time frame: Through Day 29
description: Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 2)
measure: Total number of COVID-19-related medically-attended visits
time frame: Through Day 29
description: Phase 1, Phase 2, Phase 3 (Cohort 1 and Cohort 2)
measure: Proportion of participants admitted to a hospital due to COVID-19
time frame: Through Day 29
description: Phase 1, Phase 2
measure: Proportion of participants with ≥1 outpatient or telemedicine visit due to COVID-19
time frame: Through Day 29
description: Phase 1, Phase 2
measure: Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of REGN10933
time frame: Through Day 29
description: Phase 1 Only
measure: Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10987
time frame: Through Day 29
description: Phase 1 Only
measure: Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10933
time frame: Through Day 29
description: Phase 1 Only
measure: Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10987
time frame: Through Day 29
description: Phase 1 Only
measure: Assessment of PK parameter: Time to Cmax (tmax) for REGN10933
time frame: Through Day 29
description: Phase 1 Only
measure: Assessment of PK parameter: Time to Cmax (tmax) for REGN10987
time frame: Through Day 29
description: Phase 1 Only
measure: Assessment of PK parameter: Area Under the Curve (AUC) computed from time zero to the time of the last positive concentration (AUClast) for REGN10933
time frame: Through Day 29
description: Phase 1 Only
measure: Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10987
time frame: Through Day 29
description: Phase 1 Only
measure: Immunogenicity as measured by anti-drug (ADA) to REGN10933
time frame: Through Day 29
description: Phase 1, Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)
measure: Immunogenicity as measured by ADA to REGN10987
time frame: Through Day 29
description: Phase 1, Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)
measure: Immunogenicity as measured by neutralizing antibodies (NAbs) to REGN10933
time frame: Through Day 29
description: Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)
measure: Immunogenicity as measured by NAbs to REGN10987
time frame: Through Day 29
description: Phase 2, Phase 3 (Cohort 1, Cohort 2 and Cohort 3)
measure: Proportion of participants with high viral load at each visit
time frame: Through Day 29
description: Phase 2 Only
measure: Proportion of participants with viral loads below the limit of detection at each visit
time frame: Through Day 29
description: Phase 2 Only
measure: Proportion of participants with viral loads below the lower limit of quantitation at each visit
time frame: Through Day 29
description: Phase 2 Only
measure: Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19
time frame: Through Day 29
description: Phase 2, Phase 3 (Cohort 1 and Cohort 2)
measure: Proportion of participants requiring mechanical ventilation due to COVID-19
time frame: Through Day 29
description: Phase 2, Phase 3 (Cohort 1 and Cohort 2)
measure: Number of days of hospitalization due to COVID-19
time frame: Through Day 29
description: Phase 2, Phase 3 (Cohort 1 and Cohort 2)
measure: Proportion of participants with all-cause mortality
time frame: Through Day 29
description: Phase 2 Only
measure: Time to first onset of symptoms consistent with COVID-19 (asymptomatic cohort only)
time frame: Up to Day 29
description: Phase 2 Only
measure: Duration of symptoms consistent with COVID-19
time frame: Up to Day 29
description: Phase 2 Only
measure: Proportion of participants with ≥1 COVID-19-related hospitalization or all-cause death
time frame: From Day 4 Through Day 29
description: Phase 3 (Cohort 1 and Cohort 2)
measure: Time to COVID-19 symptoms resolution
time frame: Through Day 29
description: Phase 3 (Cohort 1)
measure: Proportion of participants with ≥1 COVID-19-related hospitalization, emergency room visit, or all-cause death
time frame: Through day 29
description: Phase 3 (Cohort 1 and Cohort 2)
measure: Proportion of patients with (≥1) COVID-19-related medically-attended visit or all-cause death
time frame: Through Day 29
description: Phase 3 (Cohort 1 and Cohort 2)
measure: Proportion of participants with ≥1 COVID-19-related medically-attended visit by type of visit
time frame: Through day 29
description: Phase 3 (Cohort 1 and Cohort 2)
Type of visit defined as hospitalization, emergency room, urgent care, and/or physician's office/telemedicine
measure: Cumulative incidence of patients with ≥1 COVID-19-related hospitalization or all-cause death
time frame: Through Day 29
description: Phase 3 (Cohort 1 and Cohort 2)
measure: Cumulative incidence of patients with ≥1 COVID-19-related hospitalization, emergency room visit, or all-cause death
time frame: Through Day 29
description: Phase 3 (Cohort 1 and Cohort 2)
measure: Cumulative incidence of patients with ≥1 COVID-19-related medically-attended visit or all-cause death
time frame: Through Day 29
description: Phase 3 (Cohort 1 and Cohort 2)
measure: Proportion of participants requiring supplemental oxygen due to COVID-19
time frame: Through Day 29
description: Phase 3 (Cohort 1 and Cohort 2)
measure: Time to all-cause death
time frame: Through Day 169
description: Phase 3 (Cohort 1 and Cohort 2)
measure: All-cause death
time frame: By Day 29, Day 120, and Day 169
description: Phase 3 (Cohort 1 and Cohort 2)
arm group label: casirivimab+imdevimab low dose
arm group type: Experimental
description: Low dose or body-weight equivalent for those under 18 years of age.
intervention type: Drug
intervention name: casirivimab+imdevimab combination therapy
description: Administered intravenously (IV) single dose
arm group label: casirivimab+imdevimab low dose
other name: REGN-COV2
other name: REGN10933
other name: REGN10987
other name: REGEN-COV™
other name: Ronapreve™
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
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country: Mexico
country: Romania
country: United States
country: Chile
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Casirivimab and imdevimab drug combination
sharing ipd: Yes
ipd description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification
ipd access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
ipd url: https://vivli.org/
provided document: 
submitted: January 20, 2023
returned: February 17, 2023
submitted: March 14, 2023
returned: April 10, 2023
submitted: May 3, 2023
returned: June 1, 2023
submitted: June 26, 2023
returned: July 21, 2023
submitted: August 14, 2023
returned: September 7, 2023