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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05074433
Recruitment Status : Terminated (Emerging SARS-CoV2 variants impacting susceptibility to study drug)
First Posted : October 12, 2021
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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
Immunocompromised Drug: casirivimab+imdevimab Drug: Placebo Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
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 : October 25, 2021
Actual Primary Completion Date : May 18, 2022
Actual Study Completion Date : May 18, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases [ Time Frame: Up to 169 Days ]
    Efficacy Assessment Period (EAP)


Secondary Outcome Measures :
  1. Proportion of participants with grade ≥3 treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 253 Days ]
    EAP and follow-up period

  2. Proportion of participants with TEAEs leading to study drug discontinuation [ Time Frame: Up to 253 Days ]
    EAP and follow-up period

  3. Proportion of participants with treatment-emergent serious adverse events (SAEs) [ Time Frame: Up to 253 Days ]
    EAP and follow-up period

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

  5. Concentration of each mAb over time [ Time Frame: Up to 253 Days ]
    As applicable to the treatment arm

  6. Incidence and titer of anti-drug antibodies (ADA) over time [ Time Frame: Up to 253 Days ]
    As applicable to the treatment arm

  7. Incidence of neutralizing antibodies (NAb) to each mAb over time [ Time Frame: Up to 253 Days ]
    As applicable to the treatment arm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


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): NCT05074433


Locations
Show Show 67 study locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05074433    
Other Study ID Numbers: R10933-10987-COV-2176
2021-005222-14 ( EudraCT Number )
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022
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:
Non-response to COVID-19 vaccination
COVID-19
Immunocompromised, weakened immune system
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases