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Purpose

The primary objectives are: Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) - To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 - To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation Phase 1/2 (Cohort 1) - To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo

Condition

Eligibility

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

Inclusion Criteria

  • 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 and no alternative explanation for current clinical condition. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable. - Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤10 days before randomization - Hospitalized for ≤72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category: 1. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen 2. Cohort 1: Maintains O2 saturation >93% on low-flow oxygen as defined in the protocol 3. Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol 4. Cohort 3: On mechanical ventilation

Exclusion Criteria

  • Phase 1 Only: Patients maintaining O2 saturation >94% on room air - In the opinion of the investigator, unlikely to survive for >48 hours from screening - Receiving extracorporeal membrane oxygenation (ECMO) - Has new-onset stroke or seizure disorder during hospitalization - Initiated on renal replacement therapy due to COVID-19 NOTE: Other protocol defined inclusion / exclusion criteria apply

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Phase 1/Phase 2/Phase 3
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
On Low-Flow Oxygen 		Cohort 1 (C1): O2 saturation >93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device
  • Drug: REGN10933+REGN10987 combination therapy
    Administered intravenously (IV) single dose
    Other names:
    • REGN-COV2
    • REGEN-COV™
    • Ronapreve™
    • casirivimab
    • imdevimab
  • Drug: Placebo
    Placebo IV Single Dose
Experimental
With COVID-19 symptoms but not requiring supplemental O2 		Cohort 1A (C1A): With COVID-19 symptoms but not requiring supplemental oxygen
  • Drug: REGN10933+REGN10987 combination therapy
    Administered intravenously (IV) single dose
    Other names:
    • REGN-COV2
    • REGEN-COV™
    • Ronapreve™
    • casirivimab
    • imdevimab
  • Drug: Placebo
    Placebo IV Single Dose
Experimental
High O2 No Mechanical Ventilation 		Cohort 2 (C2): On high-intensity oxygen (O2) therapy but not on mechanical ventilation
  • Drug: REGN10933+REGN10987 combination therapy
    Administered intravenously (IV) single dose
    Other names:
    • REGN-COV2
    • REGEN-COV™
    • Ronapreve™
    • casirivimab
    • imdevimab
  • Drug: Placebo
    Placebo IV Single Dose
Experimental
On Mechanical Ventilation 		Cohort 3 (C3): On mechanical ventilation
  • Drug: REGN10933+REGN10987 combination therapy
    Administered intravenously (IV) single dose
    Other names:
    • REGN-COV2
    • REGEN-COV™
    • Ronapreve™
    • casirivimab
    • imdevimab
  • Drug: Placebo
    Placebo IV Single Dose

Recruiting Locations

More Details

NCT ID
NCT04426695
Status
Completed
Sponsor
Regeneron Pharmaceuticals

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.