COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection

Purpose

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 study are: - To evaluate additional indicators of virologic efficacy of REGN10933+REGN10987 compared to placebo - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo - To assess the concentrations of REGN10933 and REGN10987 in serum over time - To assess the immunogenicity of REGN10933 and REGN10987

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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: 1. Age ≤50 2. No obesity, with obesity defined as BMI ≥30 kg/m2 3. Does not have cardiovascular disease or hypertension 4. Does not have chronic lung disease or asthma 5. Does not have type 1 or type 2 diabetes mellitus 6. Does not have chronic kidney disease, with or without dialysis 7. Does not have chronic liver disease 8. 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

Exclusion Criteria

  • 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IV Dose 1 		Combination therapy intravenous (IV) single dose
  • Drug: REGN10933+REGN10987 combination therapy
    Administered IV or SC single dose
    Other names:
    • REGN-COV2
    • REGEN-COV™
    • Ronapreve™
    • casirivimab
    • imdevimab
Experimental
IV Dose 2 		Combination therapy IV single dose
  • Drug: REGN10933+REGN10987 combination therapy
    Administered IV or SC single dose
    Other names:
    • REGN-COV2
    • REGEN-COV™
    • Ronapreve™
    • casirivimab
    • imdevimab
Experimental
IV Dose 3 		Combination therapy IV single dose
  • Drug: REGN10933+REGN10987 combination therapy
    Administered IV or SC single dose
    Other names:
    • REGN-COV2
    • REGEN-COV™
    • Ronapreve™
    • casirivimab
    • imdevimab
Experimental
IV Dose 4 		Combination therapy IV single dose
  • Drug: REGN10933+REGN10987 combination therapy
    Administered IV or SC single dose
    Other names:
    • REGN-COV2
    • REGEN-COV™
    • Ronapreve™
    • casirivimab
    • imdevimab
Experimental
Placebo IV Dose 		Matching placebo IV single dose
  • Drug: Placebo
    Administered IV or SC single dose to match
Experimental
SC Dose 1 		Combination therapy subcutaneous (SC) single dose
  • Drug: REGN10933+REGN10987 combination therapy
    Administered IV or SC single dose
    Other names:
    • REGN-COV2
    • REGEN-COV™
    • Ronapreve™
    • casirivimab
    • imdevimab
Experimental
SC Dose 2 		Combination therapy SC single dose
  • Drug: REGN10933+REGN10987 combination therapy
    Administered IV or SC single dose
    Other names:
    • REGN-COV2
    • REGEN-COV™
    • Ronapreve™
    • casirivimab
    • imdevimab
Experimental
Placebo SC Dose 		Matching placebo SC single dose
  • Drug: Placebo
    Administered IV or SC single dose to match

Recruiting Locations

More Details

NCT ID
NCT04666441
Status
Completed
Sponsor
Regeneron Pharmaceuticals