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

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ClinicalTrials.gov Identifier: NCT04666441
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: REGN10933+REGN10987 combination therapy Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Assess the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Outpatients With SARS-CoV-2 Infection
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : April 24, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IV Dose 1
Combination therapy intravenous (IV) single dose
 Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
  • REGN-COV2
  • casirivimab
  • imdevimab
Experimental: IV Dose 2
Combination therapy IV single dose
 Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
  • REGN-COV2
  • casirivimab
  • imdevimab
Experimental: IV Dose 3
Combination therapy IV single dose
 Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
  • REGN-COV2
  • casirivimab
  • imdevimab
Experimental: IV Dose 4
Combination therapy IV single dose
 Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
  • REGN-COV2
  • casirivimab
  • imdevimab
Experimental: Placebo IV Dose
Matching placebo IV single dose
 Drug: Placebo
Administered IV or SC single dose to match
Experimental: SC Dose 1
Combination therapy subcutaneous (SC) single dose
 Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
  • REGN-COV2
  • casirivimab
  • imdevimab
Experimental: SC Dose 2
Combination therapy SC single dose
 Drug: REGN10933+REGN10987 combination therapy
Administered IV or SC single dose
Other Names:
  • REGN-COV2
  • casirivimab
  • imdevimab
Experimental: Placebo SC Dose
Matching placebo SC single dose
 Drug: Placebo
Administered IV or SC single dose to match


Outcome Measures
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Primary Outcome Measures :
  1. Time-weighted average daily change from baseline in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples [ Time Frame: Baseline to day 7 ]
    Measured in patients who have a central-lab determined RT-qPCR positive test and are seronegative at baseline


Secondary Outcome Measures :
  1. Time-weighted average daily change from baseline in viral load (log10 copies/mL) [ Time Frame: Baseline to day 5 ]
  2. Time-weighted average daily change from baseline in viral load (log10 copies/mL) in patients with high viral load [ Time Frame: Baseline to day 7 ]
  3. Time-weighted average daily change from baseline in viral load (log10 copies/mL) in patients with high viral load [ Time Frame: Baseline to day 5 ]
  4. Proportion of patients with high viral load [ Time Frame: At each visit, through day 22 ]
  5. Proportion of patients with viral loads below the limit of detection [ Time Frame: At each visit, through day 22 ]
  6. Proportion of patients with viral loads below the lower limit of quantitation [ Time Frame: At each visit, through day 22 ]
  7. Time-weighted average daily change from baseline in cycle threshold (Ct) as measured by RT-qPCR in NP samples [ Time Frame: Baseline to day 7 ]
  8. Time-weighted average daily change from baseline in Ct from day 1 to day 5, as measured by RT-qPCR in NP samples [ Time Frame: Baseline to day 5 ]
  9. Change from baseline in Ct as measured by RT-qPCR in NP samples [ Time Frame: At each visit, Baseline through day 22 ]
  10. Change from baseline in viral load as measured by RT-qPCR in NP samples [ Time Frame: At each visit, Baseline through day 22 ]
  11. Proportion of patients with treatment-emergent serious adverse events (SAEs) [ Time Frame: Through day 29 ]
  12. Proportion of patients with infusion-related reactions (grade ≥2) [ Time Frame: Through day 4 ]
  13. Proportion of patients with injection-site reactions (grade ≥2) [ Time Frame: Through day 4 ]
  14. Proportion of patients with hypersensitivity reactions (grade ≥2) [ Time Frame: Through day 29 ]
  15. Concentrations of REGN10933 in serum [ Time Frame: Through day 22 ]
  16. Concentrations of REGN10987 in serum [ Time Frame: Through day 22 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Has SARS-CoV-2-positive antigen or molecular diagnostic test ≤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, IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational)
  • Prior, current, or planned use during the study period of any authorized, approved, or investigational vaccine for COVID-19
  • Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test

NOTE: Other protocol defined inclusion/exclusion criteria apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04666441


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, Arizona
Regeneron Study Site Recruiting
Mesa, Arizona, United States, 85210
Regeneron Study Site Recruiting
Tucson, Arizona, United States, 85712
United States, California
Regeneron Study Site Recruiting
Canoga Park, California, United States, 91303
Regeneron Study Site Recruiting
Long Beach, California, United States, 90806
Regeneron Study Site Recruiting
Los Angeles, California, United States, 90036
Regeneron Study Site Recruiting
San Francisco, California, United States, 94127
Regeneron Study Site Recruiting
Santa Monica, California, United States, 90404
United States, Colorado
Regeneron Study Site Recruiting
Colorado Springs, Colorado, United States, 80907
United States, Florida
Regeneron Study Site Recruiting
DeLand, Florida, United States, 32720
Regeneron Study Site Recruiting
Fort Pierce, Florida, United States, 34982
Regeneron Study Site Recruiting
Hialeah, Florida, United States, 33010
Regeneron Study Site Recruiting
Hialeah, Florida, United States, 33012
Regeneron Study Site Recruiting
Maitland, Florida, United States, 32751
Regeneron Study Site Recruiting
Miami, Florida, United States, 33126
Regeneron Study Site Recruiting
Miami, Florida, United States, 33184
Regeneron Study Site Recruiting
Saint Petersburg, Florida, United States, 33705
Regeneron Study Site Recruiting
Tampa, Florida, United States, 33606
Regeneron Study Site Recruiting
West Palm Beach, Florida, United States, 33407
Regeneron Study Site Recruiting
Winter Haven, Florida, United States, 33880
Regeneron Study Site Recruiting
Winter Park, Florida, United States, 32789
United States, Georgia
Regeneron Study Site Recruiting
Columbus, Georgia, United States, 31904
United States, Illinois
Regeneron Study Site Recruiting
Downers Grove, Illinois, United States, 60515
United States, Iowa
Regeneron Study Site Recruiting
Ames, Iowa, United States, 50010-3014
United States, Louisiana
Regeneron Study Site Recruiting
Lake Charles, Louisiana, United States, 70601
Regeneron Study Site Recruiting
Marrero, Louisiana, United States, 70072
Regeneron Study Site Recruiting
Shreveport, Louisiana, United States, 71118
United States, Maryland
Regeneron Study Site Recruiting
Baltimore, Maryland, United States, 21201
United States, Nevada
Regeneron Study Site Recruiting
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Regeneron Study Site Recruiting
Teaneck, New Jersey, United States, 07666
United States, New York
Regeneron Study Site Recruiting
Bronx, New York, United States, 10451
United States, North Carolina
Regeneron Study Site Recruiting
Wilmington, North Carolina, United States, 28401
United States, Ohio
Regeneron Study Site Recruiting
Columbus, Ohio, United States, 43215
Regeneron Study Site Recruiting
Dayton, Ohio, United States, 45409
Regeneron Study Site Recruiting
Dayton, Ohio, United States, 45432
United States, South Carolina
Regeneron Study Site Recruiting
Charleston, South Carolina, United States, 29425
Regeneron Study Site Recruiting
Clinton, South Carolina, United States, 29325
United States, Texas
Regeneron Study Site Recruiting
Amarillo, Texas, United States, 79109
Regeneron Study Site Recruiting
Corpus Christi, Texas, United States, 78413
Regeneron Study Site Recruiting
Houston, Texas, United States, 77008
Regeneron Study Site Recruiting
Houston, Texas, United States, 77030
Regeneron Study Site Recruiting
Houston, Texas, United States, 77057
Regeneron Study Site Recruiting
Houston, Texas, United States, 77093
Regeneron Study Site Recruiting
Pearland, Texas, United States, 77584
Regeneron Study Site Recruiting
Red Oak, Texas, United States, 75154
Regeneron Study Site Recruiting
San Antonio, Texas, United States, 78249
United States, Virginia
Regeneron Study Site Recruiting
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04666441    
Other Study ID Numbers: R10933-10987-COV-20145
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) coronavirus
Non-hospitalized
Additional relevant MeSH terms:
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Infection