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

Regeneron Pharmaceuticals1,149 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,149

Conditions

COVID-19

Interventions

REGN10933+REGN10987 combination therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (57)

Regeneron Study Site

Mesa, Arizona, United States

Regeneron Study Site

Tucson, Arizona, United States

Regeneron Study Site

Canoga Park, California, United States

Regeneron Study Site

Long Beach, California, United States

Regeneron Study Site

Los Angeles, California, United States

Regeneron Study Site

Outcomes

Primary Outcomes

Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples

Time-weighted average daily change from Day 1 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

Time frame: Day 1 to Day 7

Secondary Outcomes

Time-Weighted Average Daily Change From Day 1 in Viral Load

Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

Time frame: Day 1 to Day 5

Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline

Time frame: Day 1 to Day 7

Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline

Time frame: Day 1 to Day 5

Number of Participants With High Viral Load

Number of participants with viral load greater than 10,000 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

Time frame: Day 1, Day 3, Day 5, Day 7, Day 15, Day 22

Number of Participants With Viral Loads Below the Limit of Detection

Number of participants with viral load less than 299 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

Time frame: Day 1, Day 3, Day 5, Day 7, Day 15, Day 22

Number of Participants With Viral Loads Below the Lower Limit of Quantification

Number of participants with viral load less than 714 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

Time frame: Day 1, Day 3, Day 5, Day 7, Day 15, Day 22

Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples

Change from Day 1 in Viral Load (log10 copies/mL) as Measured by Quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) Swab Samples

Time frame: Day 3, Day 5, Day 7, Day 15, Day 22

Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

Time frame: Through day 29

Number of Participants With Infusion-Related Reactions Grade 2 or Above

Time frame: Through day 4

Number of Participants With Injection-Site Reactions Grade 3 or Above

Time frame: Through day 4

Number of Participants With Hypersensitivity Reactions Grade 2 or Above

Time frame: Through day 29

Concentration of REGN10933 in Serum

Time frame: Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose

Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933

Time frame: Through day 120

Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933

Time frame: Through day 120

Concentration of REGN10987 in Serum

Time frame: Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose

Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987

Time frame: Through day 120

Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987

Time frame: Through day 120