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

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Immunocompromised

Treatments: Drug: casirivimab+imdevimab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05074433

2021-005222-14 (EudraCT Number)

R10933-10987-COV-2176

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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66 participants in 4 patient groups, including a placebo group

casirivimab+imdevimab Initial + Q4W

Experimental group

Description:

Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)

Treatment:

Drug: casirivimab+imdevimab

casirivimab+imdevimab Q4W

Experimental group

Description:

SC dose Q4W

Treatment:

Drug: casirivimab+imdevimab

casirivimab+imdevimab Q12W

Experimental group

Description:

SC dose every 12 weeks (Q12W)

Treatment:

Drug: casirivimab+imdevimab

Placebo

Placebo Comparator group

Description:

SC dose Q4W

Treatment:

Drug: Placebo