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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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT05074433
Collaborator
(none)
66
Enrollment
67
Locations
4
Arms
6.7
Actual Duration (Months)
1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Oct 25, 2021
Actual Primary Completion Date :
May 18, 2022
Actual Study Completion Date :
May 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: casirivimab+imdevimab Initial + Q4W

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

Drug: casirivimab+imdevimab
Co-administered sequentially subcutaneous (SC)
Other Names:
  • REGN-COV2
  • REGN10933
  • REGN10987
  • REGEN-COV™
  • Ronapreve™

    		•
    Experimental: casirivimab+imdevimab Q4W

    SC dose Q4W

    Drug: casirivimab+imdevimab
    Co-administered sequentially subcutaneous (SC)
    Other Names:
  • REGN-COV2
  • REGN10933
  • REGN10987
  • REGEN-COV™
  • Ronapreve™

    		•
    Experimental: casirivimab+imdevimab Q12W

    SC dose every 12 weeks (Q12W)

    Drug: casirivimab+imdevimab
    Co-administered sequentially subcutaneous (SC)
    Other Names:
  • REGN-COV2
  • REGN10933
  • REGN10987
  • REGEN-COV™
  • Ronapreve™

    		•
    Placebo Comparator: Placebo

    SC dose Q4W

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases [Up to 169 Days]

      Efficacy Assessment Period (EAP)

    Secondary Outcome Measures

    1. Proportion of participants with grade ≥3 treatment-emergent adverse events (TEAEs) [Up to 253 Days]

      EAP and follow-up period

    2. Proportion of participants with TEAEs leading to study drug discontinuation [Up to 253 Days]

      EAP and follow-up period

    3. Proportion of participants with treatment-emergent serious adverse events (SAEs) [Up to 253 Days]

      EAP and follow-up period

    4. Incidence of adverse events of special interest (AESIs) [Up to 169 Days]

      EAP

    5. Concentration of each mAb over time [Up to 253 Days]

      As applicable to the treatment arm

    6. Incidence and titer of anti-drug antibodies (ADA) over time [Up to 253 Days]

      As applicable to the treatment arm

    7. Incidence of neutralizing antibodies (NAb) to each mAb over time [Up to 253 Days]

      As applicable to the treatment arm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine

    2. 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

    3. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Central Alabama Research Birmingham Alabama United States 35205
    2 Baptist Health Center for Clinical Research Little Rock Arkansas United States 72205
    3 Regeneron Study Site Long Beach California United States 90806
    4 Regeneron Study Site Los Angeles California United States 90033
    5 Cedars-Sinai Medical Center Los Angeles California United States 90048
    6 Stanford University Palo Alto California United States 94304
    7 University of California Sacramento California United States 95817
    8 Regeneron Study Site Stanford California United States 94305
    9 James R Berenson MD Inc. West Hollywood California United States 90069
    10 University Of Colorado Aurora Colorado United States 80045
    11 Regeneron Study Site North Haven Connecticut United States 06473-2195
    12 Georgetown University Washington District of Columbia United States 20007
    13 Arthritis and Rheumatic Disease Specialties Aventura Florida United States 33180
    14 Innovative Research of West Florida, Inc. Clearwater Florida United States 33756
    15 Midway Immunology and Research Center Fort Pierce Florida United States 34982
    16 Elixia COVID-19 Hollywood Florida United States 33024
    17 AppleMed Research Group, LLC Miami Florida United States 33126
    18 De La Cruz Research Center, LLC Miami Florida United States 33184
    19 University of South Florida Tampa Florida United States 33606
    20 Florida Medical Clinic, LLC Zephyrhills Florida United States 33542
    21 Regeneron Study Site Atlanta Georgia United States 30322
    22 Regeneron Study Site Marietta Georgia United States 30060
    23 Great Lakes Clinical Trials - Ravenswood Chicago Illinois United States 60625
    24 University of Iowa Iowa City Iowa United States 52242
    25 Tulane University New Orleans Louisiana United States 70112
    26 Institute of Human Virology Baltimore Maryland United States 21201
    27 Johns Hopkins Hospital Baltimore Maryland United States 21287
    28 Laboratory of Clinical Immunology and Microbiology, NIAID Bethesda Maryland United States 20892
    29 Tufts Medical Center Boston Massachusetts United States 02111
    30 Regeneron Study Site Boston Massachusetts United States 02115
    31 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    32 University of Michigan Ann Arbor Michigan United States 48109
    33 Spectrum Health Grand Rapids Michigan United States 49503
    34 Mayo Clinic Rochester Minnesota United States 55905
    35 University of Nebraska Medical Center Omaha Nebraska United States 68198
    36 Jersey Shore University Medical Center Neptune New Jersey United States 07753
    37 Holy Name Teaneck New Jersey United States 07666
    38 Montefiore Medical Center Bronx New York United States 10467
    39 Maimonides Cancer Center Brooklyn New York United States 11220
    40 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    41 Regeneron Study Site New York New York United States 10032-3729
    42 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    43 Regeneron Study Site 2 New York New York United States 10065
    44 Regeneron Study Site Rochester New York United States 14642
    45 Regeneron Study Site Syracuse New York United States 13210
    46 SUNY Upstate Medical University Syracuse New York United States 13215
    47 Burke Primary Care Morganton North Carolina United States 28655
    48 Gabrail Cancer Center Research Canton Ohio United States 44718
    49 Regeneron Study Site Cleveland Ohio United States 44195
    50 Miami Valley Hospital Dayton Ohio United States 45409
    51 Altoona Center for Clinical Research Duncansville Pennsylvania United States 16635
    52 Penn Prevention Clinical Research Site Philadelphia Pennsylvania United States 19104
    53 Temple University Philadelphia Pennsylvania United States 19140
    54 Regeneron Study Site Providence Rhode Island United States 02903
    55 West Tennessee Research Institute Jackson Tennessee United States 38305
    56 PharmaTex Research, LLC Amarillo Texas United States 79109
    57 Central Texas Clinical Research Austin Texas United States 78705
    58 Therapeutic Concepts, PA Houston Texas United States 77004
    59 Houston Methodist Hospital Houston Texas United States 77030
    60 MD Anderson Cancer Center Houston Texas United States 77030
    61 Synergy Group Medical,LLC Houston Texas United States 77087
    62 Regeneron Study Site Richmond Virginia United States 23219
    63 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    64 Regeneron Study Site Seattle Washington United States 98109
    65 Swedish Medical Center- First Hill Seattle Washington United States 98122
    66 University of Wisconsin - Madison Madison Wisconsin United States 53792
    67 Regeneron Study Site Cuauhtemoc Distrito Federal Mexico 6700

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05074433
    Other Study ID Numbers:
    • R10933-10987-COV-2176
    • 2021-005222-14
    First Posted:
    Oct 12, 2021
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Regeneron Pharmaceuticals
    Non-response to COVID-19 vaccination
    COVID-19
    Immunocompromised, weakened immune system
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jul 29, 2022