A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prev… (NCT05074433) | Clinical Trial Compass
TerminatedPhase 3
A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults
Stopped: Emerging SARS-CoV2 variants impacting susceptibility to study drug
United States66 participantsStarted 2021-10-25
Plain-language 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
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Meets ≥1 of the following criteria:
✓. 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
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
What they're measuring
1
Cumulative Incidence of Symptomatic (Broad Term), RT-PCR-confirmed SARS-CoV-2 Infection Cases During the EAP
Timeframe: The EAP was defined as the day from first dose of study drug to day 169 +/- 7 days
✕. 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