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
Condition: COVID-19
MeSH terms: COVID-19
Intervention: casirivimab+imdevimab combination therapy
Intervention description: Administered intravenously (IV) single dose
Intervention MeSH terms: Casirivimab and imdevimab drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Phase 1/Phase 2/Phase 3
Masking: None (Open Label)
Enrollment: 10078.0
Sex: All
Healthy volunteers: No
Keywords: Coronavirus disease 2019 (COVID-19); Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2); coronavirus

Summary:

      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
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Has SARS-CoV-2-positive diagnostic test (from a sample collected ≤72 hours prior to
             randomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular
             diagnostic assay, and an appropriate sample such as nasopharyngeal [NP], nasal,
             oropharyngeal [OP], or saliva)

          -  Has symptoms consistent with COVID-19, as determined by the investigator, with onset
             ≤7 days before randomization

          -  Maintains O2 saturation ≥93% on room air

          -  Is able to understand and complete study-related questionnaires (patients aged ≥12
             years only)

        Key Exclusion Criteria:

          -  Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized
             (inpatient) for any reason at randomization

          -  Has participated, or is participating, in a clinical research study evaluating
             COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), or
             intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the
             investigational product (whichever is longer) prior to the screening visit

          -  Prior, current, or planned future use of any of the following treatments: COVID-19
             convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), IVIG (any
             indication), systemic corticosteroids (any indication), or COVID-19 treatments
             (authorized, approved, or investigational)

          -  Prior use (prior to randomization), current use (at randomization) or planned use
             (within 90 days of study drug administration or per current CDC recommendations, as
             applicable) of any authorized or approved vaccine for COVID-19

          -  Has participated, is participating or plans to participate in a clinical research
             study evaluation any authorized, approved or investigational vaccine for COVID-19

        NOTE: Other Protocol defined Inclusion/Exclusion criteria apply