A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults
Condition: Immunocompromised
MeSH terms: COVID-19
Intervention: casirivimab+imdevimab; Placebo
Intervention description: Co-administered sequentially subcutaneous (SC); Administered SC
Intervention MeSH terms: Casirivimab and imdevimab drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Non-response to COVID-19 vaccination; COVID-19; Immunocompromised, weakened immune system

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
    

Eligibility 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