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Safety, Tolerability, and Eff...

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

Last Updated: 2023-01-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

2252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-10

Study Completion Date

2021-10-22

Brief Summary

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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

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 1/Phase 2/Phase 3

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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On Low-Flow Oxygen

Cohort 1 (C1): O2 saturation \>93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device

Group Type EXPERIMENTAL

REGN10933+REGN10987 combination therapy

Intervention Type DRUG

Administered intravenously (IV) single dose

Placebo

Intervention Type DRUG

Placebo IV Single Dose

With COVID-19 symptoms but not requiring supplemental O2

Cohort 1A (C1A): With COVID-19 symptoms but not requiring supplemental oxygen

Group Type EXPERIMENTAL

REGN10933+REGN10987 combination therapy

Intervention Type DRUG

Administered intravenously (IV) single dose

Placebo

Intervention Type DRUG

Placebo IV Single Dose

High O2 No Mechanical Ventilation

Cohort 2 (C2): On high-intensity oxygen (O2) therapy but not on mechanical ventilation

Group Type EXPERIMENTAL

REGN10933+REGN10987 combination therapy

Intervention Type DRUG

Administered intravenously (IV) single dose

Placebo

Intervention Type DRUG

Placebo IV Single Dose

On Mechanical Ventilation

Cohort 3 (C3): On mechanical ventilation

Group Type EXPERIMENTAL

REGN10933+REGN10987 combination therapy

Intervention Type DRUG

Administered intravenously (IV) single dose

Placebo

Intervention Type DRUG

Placebo IV Single Dose

Interventions

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REGN10933+REGN10987 combination therapy

Administered intravenously (IV) single dose

Intervention Type DRUG

Placebo

Placebo IV Single Dose

Intervention Type DRUG

Other Intervention Names

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REGN-COV2 REGEN-COV™ Ronapreve™ casirivimab imdevimab

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Study Site

Birmingham, Alabama, United States

Site Status

Regeneron Study Site

Chandler, Arizona, United States

Site Status

Regeneron Study Site

Phoenix, Arizona, United States

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Regeneron Study Site 1

Tucson, Arizona, United States

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Regeneron Study Site

Long Beach, California, United States

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Regeneron Study Site

Mission Hills, California, United States

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Regeneron Study Site

Sacramento, California, United States

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Regeneron Study Site

Santa Monica, California, United States

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Regeneron Study Site

Stanford, California, United States

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Regeneron Study Site

Aurora, Colorado, United States

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Regeneron Study Site

Boca Raton, Florida, United States

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Regeneron Study Site

Ft. Pierce, Florida, United States

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Regeneron Study Site

Gainesville, Florida, United States

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Regeneron Study Site

Orlando, Florida, United States

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Regeneron Study Site

Pensacola, Florida, United States

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Regeneron Study Site

Sarasota, Florida, United States

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Regeneron Study Site

Tampa, Florida, United States

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Regeneron Study Site

Atlanta, Georgia, United States

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Regeneron Study Site

Atlanta, Georgia, United States

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Regeneron Study Site

Augusta, Georgia, United States

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Regeneron Study Site

Marietta, Georgia, United States

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Regeneron Study Site

Chicago, Illinois, United States

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Regeneron Study Site

Chicago, Illinois, United States

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Regeneron Study Site

Glenview, Illinois, United States

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Regeneron Study Site

Urbana, Illinois, United States

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Regeneron Study Site

Indianapolis, Indiana, United States

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Regeneron Study Site

Iowa City, Iowa, United States

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Regeneron Study Site

Louisville, Kentucky, United States

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Regeneron Study Site

Louisville, Kentucky, United States

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Regeneron Study Site

New Orleans, Louisiana, United States

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Regeneron Study Site

New Orleans, Louisiana, United States

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Regeneron Study Site

Baltimore, Maryland, United States

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Regeneron Study Site

Boston, Massachusetts, United States

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Regeneron Study Site

Boston, Massachusetts, United States

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Regeneron Study Site

Boston, Massachusetts, United States

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Regeneron Study Site

Grand Rapids, Michigan, United States

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Regeneron Study Site

Royal Oak, Michigan, United States

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Regeneron Study Site

Rochester, Minnesota, United States

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Regeneron Study Site

Chesterfield, Missouri, United States

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Regeneron Study Site

St Louis, Missouri, United States

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Regeneron Study Site

St Louis, Missouri, United States

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Regeneron Study Site

Omaha, Nebraska, United States

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Regeneron Study Site

Las Vegas, Nevada, United States

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Regeneron Study Site

Englewood, New Jersey, United States

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Regeneron Study Site

Hackensack, New Jersey, United States

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Regeneron Study Site

Morristown, New Jersey, United States

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Regeneron Study Site

Neptune City, New Jersey, United States

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Regeneron Study Site

Pennington, New Jersey, United States

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Regeneron Study Site

Summit, New Jersey, United States

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Regeneron Study Site

Teaneck, New Jersey, United States

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Regeneron Study Site

Albuquerque, New Mexico, United States

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Regeneron Study Site

Brooklyn, New York, United States

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Regeneron Study Site

Buffalo, New York, United States

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Regeneron Study Site 1

Buffalo, New York, United States

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Regeneron Study Site 2

Buffalo, New York, United States

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