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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Drug: REGN10933+REGN10987 combination therapy; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04426695

2020-002537-15 (EudraCT Number)

R10933-10987-COV-2066

Details and patient eligibility

About

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

Enrollment: 2,252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,252 participants in 4 patient groups

On Low-Flow Oxygen

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: REGN10933+REGN10987 combination therapy

With COVID-19 symptoms but not requiring supplemental O2

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: REGN10933+REGN10987 combination therapy

High O2 No Mechanical Ventilation

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: REGN10933+REGN10987 combination therapy

On Mechanical Ventilation

Experimental group

Description:

Cohort 3 (C3): On mechanical ventilation

Treatment:

Drug: Placebo

Drug: REGN10933+REGN10987 combination therapy