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

ID#: NCT05074433

Age: 12 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: October 25, 2021

End Date: June 26, 2023

Contact Information:
Clinical Trials Administrator
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: 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 collected ≤72 hours prior to randomization

4. Tested negative for the COVID-19 virus 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 (within 30 days), 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