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

Key Inclusion Criteria:

• Has SARS-CoV-2-positive diagnostic test (from a sample collected ≤72 hours prior torandomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other moleculardiagnostic 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 ≥12years 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 evaluatingCOVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), orintravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of theinvestigational product (whichever is longer) prior to the screening visit
• Prior, current, or planned future use of any of the following treatments: COVID-19convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), IVIG (anyindication), 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, asapplicable) of any authorized or approved vaccine for COVID-19
• Has participated, is participating or plans to participate in a clinical researchstudy evaluation any authorized, approved or investigational vaccine for COVID-19 NOTE: Other Protocol defined Inclusion/Exclusion criteria apply