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:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT05013632
Eligibility Criteria:
Inclusion Criteria:
* Pregnant or recently pregnant (up to 30 days after the end of pregnancy) at time of enrollment
* Age ≥18 years at time of enrollment
* With mild to severe COVID-19 during pregnancy
* Either
* Treated for COVID-19 with at least one of the medications included in Table 1 during pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP or
* Hospitalized and did not receive any pharmacological treatment specifically indicated for mild, moderate, or severe COVID-19 during pregnancy
* Resident of a country where a Central Institutional Review Board (IRB) or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study
* Signed the informed consent form and submitted the baseline module "COVID-19 Medications During This Pregnancy"
Exclusion Criteria:
● \<18 years of age
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05013632
Study Brief:
Protocol Section:
NCT05013632