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

Phase 3TerminatedNCT05074433

Regeneron Pharmaceuticals66 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Immunocompromised

Interventions

casirivimab+imdevimab

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (67)

Central Alabama Research

Birmingham, Alabama, United States

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Regeneron Study Site

Long Beach, California, United States

Regeneron Study Site

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP

Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases during the Efficacy Assessment Period (EAP)