COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection
- Conditions
- COVID-19
- Interventions
- Drug: Placebo
- Registration Number
- NCT04666441
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1149
-
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:
- Age ≤50
- No obesity, with obesity defined as BMI ≥30 kg/m2
- Does not have cardiovascular disease or hypertension
- Does not have chronic lung disease or asthma
- Does not have type 1 or type 2 diabetes mellitus
- Does not have chronic kidney disease, with or without dialysis
- Does not have chronic liver disease
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SC Dose 1 REGN10933+REGN10987 combination therapy Combination therapy subcutaneous (SC) single dose SC Dose 2 REGN10933+REGN10987 combination therapy Combination therapy SC single dose Placebo SC Dose Placebo Matching placebo SC single dose IV Dose 1 REGN10933+REGN10987 combination therapy Combination therapy intravenous (IV) single dose IV Dose 2 REGN10933+REGN10987 combination therapy Combination therapy IV single dose IV Dose 3 REGN10933+REGN10987 combination therapy Combination therapy IV single dose IV Dose 4 REGN10933+REGN10987 combination therapy Combination therapy IV single dose Placebo IV Dose Placebo Matching placebo IV single dose
- Primary Outcome Measures
Name Time Method Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples Day 1 to Day 7 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.
- Secondary Outcome Measures
Name Time Method Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 Through day 120 Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) Through day 29 Number of Participants With Hypersensitivity Reactions Grade 2 or Above Through day 29 Concentration of REGN10933 in Serum Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose Time-Weighted Average Daily Change From Day 1 in Viral Load Day 1 to Day 5 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-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline Day 1 to Day 5 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. in any participant with a viral load greater than 10,000 copies/mL at baseline.
Number of Participants With High Viral Load Day 1, Day 3, Day 5, Day 7, Day 15, Day 22 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.
Number of Participants With Viral Loads Below the Limit of Detection Day 1, Day 3, Day 5, Day 7, Day 15, Day 22 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.
Number of Participants With Viral Loads Below the Lower Limit of Quantification Day 1, Day 3, Day 5, Day 7, Day 15, Day 22 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.
Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples Day 3, Day 5, Day 7, Day 15, Day 22 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
Number of Participants With Infusion-Related Reactions Grade 2 or Above Through day 4 Number of Participants With Injection-Site Reactions Grade 3 or Above Through day 4 Concentration of REGN10987 in Serum 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 Through day 120 Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 Through day 120 Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 Through day 120
Trial Locations
- Locations (1)
Regeneron Study Site
🇺🇸Falls Church, Virginia, United States