ANTI-SPIKE

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