COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection
Condition: COVID-19
MeSH terms: COVID-19
Intervention: REGN10933+REGN10987 combination therapy; Placebo
Intervention description: Administered IV or SC single dose; Administered IV or SC single dose to match
Intervention MeSH terms: Casirivimab and imdevimab drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronavirus disease 2019 (COVID-19); Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) coronavirus; Non-hospitalized

Summary:

      The primary objective of the study is to assess the virologic efficacy of REGN10933+REGN10987
      across different intravenous and subcutaneous doses compared to placebo.

      The secondary objectives of the study are:

        -  To evaluate additional indicators of virologic efficacy of REGN10933+REGN10987 compared
           to placebo

        -  To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo

        -  To assess the concentrations of REGN10933 and REGN10987 in serum over time

        -  To assess the immunogenicity of REGN10933 and REGN10987
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Has SARS-CoV-2-positive diagnostic test from a sample collected ≤72 hours prior to
             randomization, as defined by the protocol

          -  Low-risk symptomatic patient: Has symptoms consistent with COVID-19 (as determined by
             the investigator) with onset ≤7 days before randomization, and meets all of the
             following 8 criteria:

               1. Age ≤50

               2. No obesity, with obesity defined as BMI ≥30 kg/m2

               3. Does not have cardiovascular disease or hypertension

               4. Does not have chronic lung disease or asthma

               5. Does not have type 1 or type 2 diabetes mellitus

               6. Does not have chronic kidney disease, with or without dialysis

               7. Does not have chronic liver disease

               8. Is not pregnant or

          -  Asymptomatic patient: Has had no symptoms consistent with COVID-19 (as determined by
             the investigator) occurring at any time <2 months prior to randomization

          -  Maintains O2 saturation ≥93% on room air

        Key Exclusion Criteria:

          -  Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized
             (inpatient) for any reason at randomization

          -  Has a known positive SARS-CoV-2 serologic test

          -  Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected
             >72 hours prior to randomization

          -  Is immunosuppressed, based on investigator's assessment

          -  Has participated, or is participating, in a clinical research study evaluating
             COVID-19 convalescent plasma, mAbs against SARS-CoV-2, 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 time period given per CDC guidance but no sooner than 22 days of study drug
             administration) of any authorized or approved vaccine for COVID-19

          -  Has known active infection with influenza or other non-SARS-CoV-2 respiratory
             pathogen, confirmed by a diagnostic test

          -  Has participated, is participating, or plans to participate in a clinical research
             study evaluating any authorized, approved, or investigational vaccine for COVID-19

        NOTE: Other protocol defined inclusion/exclusion criteria apply