Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19

Inclusion Criteria

• •Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal \[OP\], or saliva) ≤72 hours prior to randomization and no alternative explanation for current clinical condition. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable.
• •Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤10 days before randomization
• •Hospitalized for ≤72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category:
• •1. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen
• •2. Cohort 1: Maintains O2 saturation \>93% on low-flow oxygen as defined in the protocol
• •3. Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol
• •4. Cohort 3: On mechanical ventilation