Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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 load of SARS-CoV-2
Phase 2
• To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing
viral load of SARS-CoV-2
Phase 3
- Cohort 1 (≥18 Years Old, Not Pregnant at Randomization)
• To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo as
measured by COVID-19-related hospitalizations or all-cause death
- Cohort 2 (<18 Years Old, Not Pregnant at Randomization)
- To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
- To further characterize the concentrations of REGN10933 and REGN10987 in serum over
time
- Cohort 3 (Pregnant at Randomization) • To evaluate the safety and tolerability of
REGN10933+REGN10987
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Key Inclusion Criteria:
- Has SARS-CoV-2-positive diagnostic test (from a sample collected ≤72 hours prior to
randomization, using a validated SARS-CoV-2 antigen, RT-PCR, or other molecular
diagnostic assay, and an appropriate sample such as nasopharyngeal [NP], nasal,
oropharyngeal [OP], or saliva)
- Has symptoms consistent with COVID-19, as determined by the investigator, with onset
≤7 days before randomization
- Maintains O2 saturation ≥93% on room air
- Is able to understand and complete study-related questionnaires (patients aged ≥12
years only)
Key Exclusion Criteria:
- Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized
(inpatient) for any reason at randomization
- Has participated, or is participating, in a clinical research study evaluating
COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), or
intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the
investigational product (whichever is longer) prior to the screening visit
- Prior, current, or planned future use of any of the following treatments: COVID-19
convalescent plasma, mAbs against SARS-CoV-2 (eg, bamlanivimab), IVIG (any
indication), systemic corticosteroids (any indication), or COVID-19 treatments
(authorized, approved, or investigational)
- Prior use (prior to randomization), current use (at randomization) or planned use
(within 90 days of study drug administration or per current CDC recommendations, as
applicable) of any authorized or approved vaccine for COVID-19
- Has participated, is participating or plans to participate in a clinical research
study evaluation any authorized, approved or investigational vaccine for COVID-19
NOTE: Other Protocol defined Inclusion/Exclusion criteria apply