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Purpose

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

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT05074433
Status
Terminated
Sponsor
Regeneron Pharmaceuticals

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.