Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT05074433
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05074433
Study Brief:
Protocol Section:
NCT05074433