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A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients With COVID-19
Objective
The primary objectives are:
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 shedding of SARS-CoV-2
Phase 2
- To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral shedding of SARS-CoV-2
Phase 3
- To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo.
Study Arms
Experimental: REGN10933+REGN10987 low dose
Intervention: Drug: REGN10933+REGN10987 combination therapy
Experimental: REGN10933+REGN10987 high dose
Intervention: Drug: REGN10933+REGN10987 combination therapy
Placebo Comparator: Placebo
Intervention: Drug: Placebo
Eligibility
- 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. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable
- Meets 1 of the following 2 criteria:
- Symptomatic Cohort (All Phases): Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization or
- Asymptomatic Cohort (Phase 2): Meets all of the following:
- Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time <2 months prior to randomization
- Has had no positive SARS-CoV-2 test results from a sample collected >7 days prior to randomization
- Has had no known contact (of any duration) with an individual who has confirmed COVID-19 or confirmed positive SARS-COV-2 test result >14 days prior to randomization.
- Has experienced COVID-19 symptoms for <7 days
- Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤7 days before randomization
NCT ID
NCT04425629
