Status:
COMPLETED
COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to assess the virologic efficacy of REGN10933+REGN10987 across different intravenous and subcutaneous doses compared to placebo. The secondary objectives of the ...
Eligibility Criteria
Inclusion
- Key
- Has SARS-CoV-2-positive diagnostic test from a sample collected ≤72 hours prior to randomization, as defined by the protocol
- Low-risk symptomatic patient: Has symptoms consistent with COVID-19 (as determined by the investigator) with onset ≤7 days before randomization, and meets all of the following 8 criteria:
- Age ≤50
- No obesity, with obesity defined as BMI ≥30 kg/m2
- Does not have cardiovascular disease or hypertension
- Does not have chronic lung disease or asthma
- Does not have type 1 or type 2 diabetes mellitus
- Does not have chronic kidney disease, with or without dialysis
- Does not have chronic liver disease
- Is not pregnant or
- Asymptomatic patient: Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time \<2 months prior to randomization
- Maintains O2 saturation ≥93% on room air
- Key
Exclusion
- Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
- Has a known positive SARS-CoV-2 serologic test
- Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected \>72 hours prior to randomization
- Is immunosuppressed, based on investigator's assessment
- Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, 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 time period given per CDC guidance but no sooner than 22 days of study drug administration) of any authorized or approved vaccine for COVID-19
- Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test
- Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational vaccine for COVID-19
- NOTE: Other protocol defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2021
Estimated Enrollment :
1149 Patients enrolled
Trial Details
Trial ID
NCT04666441
Start Date
December 15 2020
End Date
September 21 2021
Last Update
April 8 2022
Active Locations (57)
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1
Regeneron Study Site
Mesa, Arizona, United States, 85210
2
Regeneron Study Site
Tucson, Arizona, United States, 85712
3
Regeneron Study Site
Canoga Park, California, United States, 91303
4
Regeneron Study Site
Long Beach, California, United States, 90806