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

• Status: Completed
• Trial end date: 2021-06-04
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives are:

Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)

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

• To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation

Phase 1/2 (Cohort 1)

• To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals

Criteria

Key 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

Key Exclusion Criteria:

• Phase 1 Only: Patients maintaining O2 saturation >94% on room air

• In the opinion of the investigator, unlikely to survive for >48 hours from screening

• Receiving extracorporeal membrane oxygenation (ECMO)

• Has new-onset stroke or seizure disorder during hospitalization

• Initiated on renal replacement therapy due to COVID-19

NOTE: Other protocol defined inclusion / exclusion criteria apply