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

NCT04666441 | Completed Phase 2 Results FDA Drug

• 1 other identifier: R10933-10987-COV-20145
• Study Type: interventional
• Target: 1,149
• Locations: 1 country
• Sites: 57

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

Conditions

COVID-19

Keywords

Coronavirus disease 2019 (COVID-19); Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) coronavirus; Non-hospitalized

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 to Day 7

Secondary Outcomes (17)

• 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 in Participants With High Viral Load at Baseline

  Day 1 to Day 7

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

  Day 1 to Day 5

• Number of Participants With High Viral Load

  Day 1, Day 3, Day 5, Day 7, Day 15, Day 22

• Number of Participants With Viral Loads Below the Limit of Detection

  Day 1, Day 3, Day 5, Day 7, Day 15, Day 22

Study Arms (8)

IV Dose 1

EXPERIMENTAL

Combination therapy intravenous (IV) single dose

Drug: REGN10933+REGN10987 combination therapy

IV Dose 2

EXPERIMENTAL

Combination therapy IV single dose

Drug: REGN10933+REGN10987 combination therapy

IV Dose 3

EXPERIMENTAL

Combination therapy IV single dose

Drug: REGN10933+REGN10987 combination therapy

IV Dose 4

EXPERIMENTAL

Combination therapy IV single dose

Drug: REGN10933+REGN10987 combination therapy

Placebo IV Dose

EXPERIMENTAL

Matching placebo IV single dose

Drug: Placebo

SC Dose 1

EXPERIMENTAL

Combination therapy subcutaneous (SC) single dose

Drug: REGN10933+REGN10987 combination therapy

SC Dose 2

EXPERIMENTAL

Combination therapy SC single dose

Drug: REGN10933+REGN10987 combination therapy

Placebo SC Dose

EXPERIMENTAL

Matching placebo SC single dose

Drug: Placebo

Interventions

REGN10933+REGN10987 combination therapy DRUG

Administered IV or SC single dose

Also known as: REGN-COV2, REGEN-COV™, Ronapreve™, casirivimab, imdevimab

IV Dose 1; IV Dose 2; IV Dose 3; IV Dose 4; SC Dose 1; SC Dose 2

Placebo DRUG

Administered IV or SC single dose to match

Placebo IV Dose; Placebo SC Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (57)

Regeneron Study Site

Mesa, Arizona, 85210, United States

Location

Regeneron Study Site

Tucson, Arizona, 85712, United States

Location

Regeneron Study Site

Canoga Park, California, 91303, United States

Location

Regeneron Study Site

Long Beach, California, 90806, United States

Location

Regeneron Study Site

Los Angeles, California, 90036, United States

Location

Regeneron Study Site

Rolling Hills Estates, California, 90274, United States

Location

Regeneron Study Site

San Francisco, California, 94127, United States

Location

Regeneron Study Site

Santa Monica, California, 90404, United States

Location

Regeneron Study Site

Stanford, California, 94305, United States

Location

Regeneron Study Site

Colorado Springs, Colorado, 80907, United States

Location

Regeneron Study Site

Washington D.C., District of Columbia, 20037, United States

Location

Regeneron Study Site

DeLand, Florida, 32720, United States

Location

Regeneron Study Site

Ft. Pierce, Florida, 34982, United States

Location

Regeneron Study Site

Hialeah, Florida, 33010, United States

Location

Regeneron Study Site

Hialeah, Florida, 33012, United States

Location

Regeneron Study Site

Maitland, Florida, 32751, United States

Location

Regeneron Study Site

Miami, Florida, 33126, United States

Location

Regeneron Study Site

Miami, Florida, 33184, United States

Location

Regeneron Study Site

St. Petersburg, Florida, 33705, United States

Location

Regeneron Study Site

Tampa, Florida, 33606, United States

Location

Regeneron Study Site

West Palm Beach, Florida, 33407, United States

Location

Regeneron Study Site

Winter Haven, Florida, 33880, United States

Location

Regeneron Study Site

Winter Park, Florida, 32789, United States

Location

Regeneron Study Site

Atlanta, Georgia, 30322, United States

Location

Regeneron Study Site

Columbus, Georgia, 31904, United States

Location

Regeneron Study Site

Downers Grove, Illinois, 60515, United States

Location

Regeneron Study Site

Ames, Iowa, 50010-3014, United States

Location

Regeneron Study Site

Iowa City, Iowa, 52242, United States

Location

Regeneron Study Site

Lake Charles, Louisiana, 70601, United States

Location

Regeneron Study Site

Marrero, Louisiana, 70072, United States

Location

Regeneron Study Site

Shreveport, Louisiana, 71118, United States

Location

Regeneron Study Site

Baltimore, Maryland, 21201, United States

Location

Regeneron Study Site

Las Vegas, Nevada, 89109, United States

Location

Regeneron Study Site

Teaneck, New Jersey, 07666, United States

Location

Regeneron Study Site

New York, New York, 10037, United States

Location

Regeneron Study Site

The Bronx, New York, 10451, United States

Location

Regeneron Study Site

Charlotte, North Carolina, 28209, United States

Location

Regeneron Study Site

Durham, North Carolina, 27705, United States

Location

Regeneron Study Site

Wilmington, North Carolina, 28401, United States

Location

Regeneron Study Site

Columbus, Ohio, 43215, United States

Location

Regeneron Study Site

Dayton, Ohio, 45409, United States

Location

Regeneron Study Site

Dayton, Ohio, 45432, United States

Location

Regeneron Study Site

Philadelphia, Pennsylvania, 19140, United States

Location

Regeneron Study Site

Charleston, South Carolina, 29425, United States

Location

Regeneron Study Site

Clinton, South Carolina, 29325, United States

Location

Regeneron Study Site

Amarillo, Texas, 79109, United States

Location

Regeneron Study Site

Corpus Christi, Texas, 78413, United States

Location

Regeneron Study Site

Houston, Texas, 77008, United States

Location

Regeneron Study Site

Houston, Texas, 77030, United States

Location

Regeneron Study Site

Houston, Texas, 77057, United States

Location

Regeneron Study Site

Houston, Texas, 77093, United States

Location

Regeneron Study Site

Pearland, Texas, 77584, United States

Location

Regeneron Study Site

Red Oak, Texas, 75154, United States

Location

Regeneron Study Site

San Antonio, Texas, 78249, United States

Location

Regeneron Study Site

Splendora, Texas, 77372, United States

Location

Regeneron Study Site

Tyler, Texas, 75701, United States

Location

Regeneron Study Site

Falls Church, Virginia, 22042, United States

Location

Related Publications (3)

• 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.

  PMID: 35969402 DERIVED

• 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.

  PMID: 35713300 DERIVED

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

casirivimab and imdevimab drug combination; casirivimab; imdevimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 14, 2020
• Study Start: December 15, 2020
• Primary Completion: March 4, 2021
• Study Completion: September 21, 2021
• Last Updated: April 8, 2022
• Results First Posted: April 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

US (57)