COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection
NCT ID: NCT04666441
Last Updated: 2022-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1149 participants
INTERVENTIONAL
2020-12-15
2021-09-21
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IV Dose 1
Combination therapy intravenous (IV) single dose
REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
IV Dose 2
Combination therapy IV single dose
REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
IV Dose 3
Combination therapy IV single dose
REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
IV Dose 4
Combination therapy IV single dose
REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Placebo IV Dose
Matching placebo IV single dose
Placebo
Administered IV or SC single dose to match
SC Dose 1
Combination therapy subcutaneous (SC) single dose
REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
SC Dose 2
Combination therapy SC single dose
REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Placebo SC Dose
Matching placebo SC single dose
Placebo
Administered IV or SC single dose to match
Interventions
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REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Placebo
Administered IV or SC single dose to match
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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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
Rolling Hills Estates, California, United States
Regeneron Study Site
San Francisco, California, United States
Regeneron Study Site
Santa Monica, California, United States
Regeneron Study Site
Stanford, California, United States
Regeneron Study Site
Colorado Springs, Colorado, United States
Regeneron Study Site
Washington D.C., District of Columbia, United States
Regeneron Study Site
DeLand, Florida, United States
Regeneron Study Site
Ft. Pierce, Florida, United States
Regeneron Study Site
Hialeah, Florida, United States
Regeneron Study Site
Hialeah, Florida, United States
Regeneron Study Site
Maitland, Florida, United States
Regeneron Study Site
Miami, Florida, United States
Regeneron Study Site
Miami, Florida, United States
Regeneron Study Site
St. Petersburg, Florida, United States
Regeneron Study Site
Tampa, Florida, United States
Regeneron Study Site
West Palm Beach, Florida, United States
Regeneron Study Site
Winter Haven, Florida, United States
Regeneron Study Site
Winter Park, Florida, United States
Regeneron Study Site
Atlanta, Georgia, United States
Regeneron Study Site
Columbus, Georgia, United States
Regeneron Study Site
Downers Grove, Illinois, United States
Regeneron Study Site
Ames, Iowa, United States
Regeneron Study Site
Iowa City, Iowa, United States
Regeneron Study Site
Lake Charles, Louisiana, United States
Regeneron Study Site
Marrero, Louisiana, United States
Regeneron Study Site
Shreveport, Louisiana, United States
Regeneron Study Site
Baltimore, Maryland, United States
Regeneron Study Site
Las Vegas, Nevada, United States
Regeneron Study Site
Teaneck, New Jersey, United States
Regeneron Study Site
New York, New York, United States
Regeneron Study Site
The Bronx, New York, United States
Regeneron Study Site
Charlotte, North Carolina, United States
Regeneron Study Site
Durham, North Carolina, United States
Regeneron Study Site
Wilmington, North Carolina, United States
Regeneron Study Site
Columbus, Ohio, United States
Regeneron Study Site
Dayton, Ohio, United States
Regeneron Study Site
Dayton, Ohio, United States
Regeneron Study Site
Philadelphia, Pennsylvania, United States
Regeneron Study Site
Charleston, South Carolina, United States
Regeneron Study Site
Clinton, South Carolina, United States
Regeneron Study Site
Amarillo, Texas, United States
Regeneron Study Site
Corpus Christi, Texas, United States
Regeneron Study Site
Houston, Texas, United States
Regeneron Study Site
Houston, Texas, United States
Regeneron Study Site
Houston, Texas, United States
Regeneron Study Site
Houston, Texas, United States
Regeneron Study Site
Pearland, Texas, United States
Regeneron Study Site
Red Oak, Texas, United States
Regeneron Study Site
San Antonio, Texas, United States
Regeneron Study Site
Splendora, Texas, United States
Regeneron Study Site
Tyler, Texas, United States
Regeneron Study Site
Falls Church, Virginia, United States
Countries
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References
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Portal-Celhay C, Forleo-Neto E, Eagan W, Musser BJ, Davis JD, Turner KC, Norton T, Hooper AT, Hamilton JD, Pan C, Mahmood A, Baum A, Kyratsous CA, Kim Y, Parrino J, Kampman W, Roque-Guerrero L, Stoici R, Fatakia A, Soo Y, Geba GP, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman GA, Yancopoulos GD, Weinreich DM; COVID-19 Phase 2 Dose-Ranging Study Team. Virologic Efficacy of Casirivimab and Imdevimab COVID-19 Antibody Combination in Outpatients With SARS-CoV-2 Infection: A Phase 2 Dose-Ranging Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225411. doi: 10.1001/jamanetworkopen.2022.25411.
Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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R10933-10987-COV-20145
Identifier Type: -
Identifier Source: org_study_id
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