Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19

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

  • COVID-19

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