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

Phase 3

Terminated

Conditions: Immunocompromised

Interventions: Drug: casirivimab+imdevimab
Drug: Placebo

Registration Number: NCT05074433

Lead Sponsor: Regeneron Pharmaceuticals

Brief 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

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 66

Inclusion Criteria

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
Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive full course of vaccine
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
Tested negative for the COVID-19 virus within 72 hours prior to randomization

Key

Exclusion Criteria

Weighs <40 kg (only applies to participants ≥12 to <18 years of age)
Has any signs or symptoms consistent with COVID-19
Past COVID-19 infection within 90 days prior to randomization
Planned use of any investigational, authorized, or approved vaccine for COVID-19 within 90 days of the last dose of study drug
Prior, current, or planned use of any of COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 or any COVID-19 treatment
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
Has any known active acute respiratory infection
Has persistent (refractory to treatment for ≥14 days) bacterial or fungal infection
Has known allergy or hypersensitivity to components of the study drugs

NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
casirivimab+imdevimab Q4W	casirivimab+imdevimab	SC dose Q4W
casirivimab+imdevimab Initial + Q4W	casirivimab+imdevimab	Initial subcutaneous (SC) dose, then SC dose every 4 weeks (Q4W)
casirivimab+imdevimab Q12W	casirivimab+imdevimab	SC dose every 12 weeks (Q12W)
Placebo	Placebo	SC dose Q4W

Primary Outcome Measures

Name	Time	Method
Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP	The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days	Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases during the Efficacy Assessment Period (EAP)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the Follow-Up Period	End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Concentration of Casirivimab Over Time	Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Number of Participants With Grade ≥3 Treatment-emergent Adverse Events (TEAEs) During the EAP	The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Concentration of Imdevimab Over Time	Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Incidence of Neutralizing Antibodies (NAb) to Each mAb Over Time	Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the Follow-Up Period	End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the EAP	The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Follow-Up Period	End of EAP to the end of the Follow-Up Period (Day 169 to 205, approximately ~1 months)
Number of Participants With TEAEs Leading to Study Drug Discontinuation During the EAP	The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Incidence of Adverse Events of Special Interest (AESIs) During the EAP	The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
Incidence of Anti-drug Antibodies (ADA) Over Time	Up to 28 days postdose for the Q4W groups and 84 days postdose for the Q12 group

Trial Locations

Locations (53): Central Alabama Research
🇺🇸
Birmingham, Alabama, United States
Baptist Health Center for Clinical Research
🇺🇸
Little Rock, Arkansas, United States
Regeneron Study Site
🇲🇽
Cuauhtémoc, Mexico City, Mexico
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Stanford University
🇺🇸
Palo Alto, California, United States
University of California
🇺🇸
Sacramento, California, United States
James R Berenson MD Inc.
🇺🇸
West Hollywood, California, United States
University Of Colorado
🇺🇸
Aurora, Colorado, United States
Georgetown University
🇺🇸
Washington D.C., District of Columbia, United States
Arthritis and Rheumatic Disease Specialties
🇺🇸
Aventura, Florida, United States
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Central Alabama Research
🇺🇸Birmingham, Alabama, United States