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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: COVID-19

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04666441

R10933-10987-COV-20145

Details and patient eligibility

About

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

Enrollment: 1,149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,149 participants in 8 patient groups

IV Dose 1

Experimental group

Description:

Combination therapy intravenous (IV) single dose

Treatment:

Drug: REGN10933+REGN10987 combination therapy

IV Dose 2

Experimental group

Description:

Combination therapy IV single dose

Treatment:

Drug: REGN10933+REGN10987 combination therapy

IV Dose 3

Experimental group

Description:

Combination therapy IV single dose

Treatment:

Drug: REGN10933+REGN10987 combination therapy

IV Dose 4

Experimental group

Description:

Combination therapy IV single dose

Treatment:

Drug: REGN10933+REGN10987 combination therapy

Placebo IV Dose

Experimental group

Description:

Matching placebo IV single dose

Treatment:

Drug: Placebo

SC Dose 1

Experimental group

Description:

Combination therapy subcutaneous (SC) single dose

Treatment:

Drug: REGN10933+REGN10987 combination therapy

SC Dose 2

Experimental group

Description:

Combination therapy SC single dose

Treatment:

Drug: REGN10933+REGN10987 combination therapy

Placebo SC Dose

Experimental group

Description:

Matching placebo SC single dose

Treatment:

Drug: Placebo