Valley wants our patients and community to be on the alert against medical billing scams. Learn how to protect yourself and your personal information from scammers posing as hospital representatives.
Read MoreA 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