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A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults

Primary Purpose

Immunocompromised

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
casirivimab+imdevimab
Placebo
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immunocompromised focused on measuring Non-response to COVID-19 vaccination, COVID-19, Immunocompromised, weakened immune system

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Meets ≥1 of the following criteria:

    • Is immunocompromised, including people with transplant, who have cancer, primary immunodeficiencies, HIV, rheumatological disease, autoimmune disease, multiple sclerosis OR
    • Currently taking immunosuppressant drugs
  2. Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine
  3. Has documented negative serology/antibody response in an anti-SARS-CoV-2 spike protein IgG clinical test or ≤50 U/mL on the Elecsys® SARS-CoV-2 S Total Ig test
  4. Tested negative for the COVID-19 virus within 72 hours prior to randomization

Key Exclusion Criteria:

  1. Weighs <40 kg (only applies to participants ≥12 to <18 years of age)
  2. Has any signs or symptoms consistent with COVID-19
  3. Past COVID-19 infection within 90 days prior to randomization
  4. Planned use of any investigational, authorized, or approved vaccine for COVID-19 within 90 days of the last dose of study drug
  5. Prior, current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any COVID-19 treatment
  6. Is planned to begin immunoglobulin (IVIG) or immunoglobulin (SCIG) therapy, is planned to have a change to existing IVIG or SCIG, or has been on a chronic stable dose of their IVIG or SCIG regimen for less than 90 days prior to screening
  7. Has any known active acute respiratory infection
  8. Has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection
  9. Has known allergy or hypersensitivity to components of the study drugs

NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Sites / Locations

  • Central Alabama Research
  • Baptist Health Center for Clinical Research
  • Regeneron Study Site
  • Regeneron Study Site
  • Cedars-Sinai Medical Center
  • Stanford University
  • University of California
  • Regeneron Study Site
  • James R Berenson MD Inc.
  • University Of Colorado
  • Regeneron Study Site
  • Georgetown University
  • Arthritis and Rheumatic Disease Specialties
  • Innovative Research of West Florida, Inc.
  • Midway Immunology and Research Center
  • Elixia COVID-19
  • AppleMed Research Group, LLC
  • De La Cruz Research Center, LLC
  • University of South Florida
  • Florida Medical Clinic, LLC
  • Regeneron Study Site
  • Regeneron Study Site
  • Great Lakes Clinical Trials - Ravenswood
  • University of Iowa
  • Tulane University
  • Institute of Human Virology
  • Johns Hopkins Hospital
  • Laboratory of Clinical Immunology and Microbiology, NIAID
  • Tufts Medical Center
  • Regeneron Study Site
  • Beth Israel Deaconess Medical Center
  • University of Michigan
  • Spectrum Health
  • Mayo Clinic
  • University of Nebraska Medical Center
  • Jersey Shore University Medical Center
  • Holy Name
  • Montefiore Medical Center
  • Maimonides Cancer Center
  • Icahn School of Medicine at Mount Sinai
  • Regeneron Study Site
  • Memorial Sloan Kettering Cancer Center
  • Regeneron Study Site 2
  • Regeneron Study Site
  • Regeneron Study Site
  • SUNY Upstate Medical University
  • Burke Primary Care
  • Gabrail Cancer Center Research
  • Regeneron Study Site
  • Miami Valley Hospital
  • Altoona Center for Clinical Research
  • Penn Prevention Clinical Research Site
  • Temple University
  • Regeneron Study Site
  • West Tennessee Research Institute
  • PharmaTex Research, LLC
  • Central Texas Clinical Research
  • Therapeutic Concepts, PA
  • Houston Methodist Hospital
  • MD Anderson Cancer Center
  • Synergy Group Medical,LLC
  • Regeneron Study Site
  • Fred Hutchinson Cancer Research Center
  • Regeneron Study Site
  • Swedish Medical Center- First Hill
  • University of Wisconsin - Madison
  • Regeneron Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

casirivimab+imdevimab Initial + Q4W

casirivimab+imdevimab Q4W

casirivimab+imdevimab Q12W

Placebo

Arm Description

Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)

SC dose Q4W

SC dose every 12 weeks (Q12W)

SC dose Q4W

Outcomes

Primary Outcome Measures

Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP
Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases during the Efficacy Assessment Period (EAP)

Secondary Outcome Measures

Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the EAP
Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the Follow-Up Period
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the EAP
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the Follow-Up Period
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the EAP
Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Follow-Up Period
Incidence of Adverse Events of Special Interest (AESIs) During the EAP
Concentration of Casirivimab Over Time
Concentration of Imdevimab Over Time
Incidence of Anti-drug Antibodies (ADA) Over Time
Incidence of Neutralizing Antibodies (NAb) to Each mAb Over Time

Full Information

First Posted
October 8, 2021
Last Updated
June 28, 2023
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05074433
Brief Title
A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies as Pre-Exposure Prophylaxis to Prevent COVID-19 in Immunocompromised Participants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Emerging SARS-CoV2 variants impacting susceptibility to study drug
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
May 18, 2022 (Actual)
Study Completion Date
May 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the study is to evaluate the effect of casirivimab+imdevimab, compared with placebo, in preventing symptomatic SARS-CoV-2 infection in immunocompromised participants. The secondary objectives of the study are: To evaluate the safety and tolerability of repeated SC injections of casirivimab+imdevimab in the study population To characterize concentrations of casirivimab and imdevimab in serum over time To assess the immunogenicity of casirivimab and imdevimab

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunocompromised
Keywords
Non-response to COVID-19 vaccination, COVID-19, Immunocompromised, weakened immune system

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
casirivimab+imdevimab Initial + Q4W
Arm Type
Experimental
Arm Description
Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
Arm Title
casirivimab+imdevimab Q4W
Arm Type
Experimental
Arm Description
SC dose Q4W
Arm Title
casirivimab+imdevimab Q12W
Arm Type
Experimental
Arm Description
SC dose every 12 weeks (Q12W)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
SC dose Q4W
Intervention Type
Drug
Intervention Name(s)
casirivimab+imdevimab
Other Intervention Name(s)
REGN-COV2, REGN10933, REGN10987, REGEN-COV™, Ronapreve™
Intervention Description
Co-administered sequentially subcutaneous (SC)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP
Description
Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases during the Efficacy Assessment Period (EAP)
Time Frame
The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Secondary Outcome Measure Information:
Title
Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the EAP
Time Frame
The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Title
Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the Follow-Up Period
Time Frame
End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Title
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the EAP
Time Frame
The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Title
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the Follow-Up Period
Time Frame
End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Title
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the EAP
Time Frame
The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Title
Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Follow-Up Period
Time Frame
End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Title
Incidence of Adverse Events of Special Interest (AESIs) During the EAP
Time Frame
The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Title
Concentration of Casirivimab Over Time
Time Frame
Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Title
Concentration of Imdevimab Over Time
Time Frame
Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Title
Incidence of Anti-drug Antibodies (ADA) Over Time
Time Frame
Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Title
Incidence of Neutralizing Antibodies (NAb) to Each mAb Over Time
Time Frame
Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Meets ≥1 of the following criteria: Is immunocompromised, including people with transplant, who have cancer, primary immunodeficiencies, HIV, rheumatological disease, autoimmune disease, multiple sclerosis OR Currently taking immunosuppressant drugs Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine Has documented negative serology/antibody response in an anti-SARS-CoV-2 spike protein IgG clinical test or ≤50 U/mL on the Elecsys® SARS-CoV-2 S Total Ig test Tested negative for the COVID-19 virus within 72 hours prior to randomization Key Exclusion Criteria: Weighs <40 kg (only applies to participants ≥12 to <18 years of age) Has any signs or symptoms consistent with COVID-19 Past COVID-19 infection within 90 days prior to randomization Planned use of any investigational, authorized, or approved vaccine for COVID-19 within 90 days of the last dose of study drug Prior, current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any COVID-19 treatment Is planned to begin immunoglobulin (IVIG) or immunoglobulin (SCIG) therapy, is planned to have a change to existing IVIG or SCIG, or has been on a chronic stable dose of their IVIG or SCIG regimen for less than 90 days prior to screening Has any known active acute respiratory infection Has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection Has known allergy or hypersensitivity to components of the study drugs NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Central Alabama Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Regeneron Study Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Regeneron Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Regeneron Study Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
James R Berenson MD Inc.
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
University Of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Regeneron Study Site
City
North Haven
State/Province
Connecticut
ZIP/Postal Code
06473-2195
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Arthritis and Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Innovative Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Midway Immunology and Research Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Elixia COVID-19
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
AppleMed Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
De La Cruz Research Center, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Florida Medical Clinic, LLC
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Regeneron Study Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Regeneron Study Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Great Lakes Clinical Trials - Ravenswood
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Institute of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Laboratory of Clinical Immunology and Microbiology, NIAID
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Regeneron Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Holy Name
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Maimonides Cancer Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Regeneron Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Regeneron Study Site 2
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Regeneron Study Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Regeneron Study Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13215
Country
United States
Facility Name
Burke Primary Care
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Regeneron Study Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Penn Prevention Clinical Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Regeneron Study Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
PharmaTex Research, LLC
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Therapeutic Concepts, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Synergy Group Medical,LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77087
Country
United States
Facility Name
Regeneron Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Regeneron Study Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Swedish Medical Center- First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Regeneron Study Site
City
Cuauhtemoc
State/Province
Distrito Federal
ZIP/Postal Code
6700
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing 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.
IPD Sharing 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
IPD Sharing URL
https://vivli.org/

Learn more about this trial

A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults

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