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 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT04582266
Eligibility Criteria:
Inclusion Criteria: Arm 1 (Pregnant Women)
* Of legal age or otherwise able to provide independent informed consent or is unable to provide informed consent (e.g., impaired capacity) and a Legally Authorized Representative (LAR) is willing and able to provide written informed consent on behalf of the participant
* At study entry, viable intra-uterine pregnancy of any gestational age, based on medical records.
* At study entry, hospitalized AND has confirmed or suspected COVID-19, based on medical records.
* At study entry, receiving or expected to receive RDV for COVID-19 clinical care, as prescribed by the clinical care provider and documented in medical records.
Inclusion Criteria - Arm 2 (Non-Pregnant Women)
* Of legal age or otherwise able to provide independent informed consent or is unable to provide informed consent (e.g., impaired capacity) and a Legally Authorized Representative (LAR) is willing and able to provide written informed consent on behalf of the participant
* At study entry, between 18 and 45 years of age, based on medical records and participant report.
* Assigned female at birth and at study entry not taking cross-sex hormone therapy.
* At study entry, not suspected to be pregnant, based on participant report and/or investigator or designee determination.
* At study entry, hospitalized AND has confirmed or suspected COVID-19, based on medical records.
* At study entry, receiving or expected to receive RDV for COVID-19 clinical care, as prescribed by the clinical care provider and documented in medical records.
Exclusion Criteria:
* At study entry, has started or received the 4th RDV infusion.
* At study entry, evidence of post-menopausal status (medical or surgical), based on medical records and/or participant report.
* At study entry, any contraindications to RDV treatment for COVID-19, based on investigator or designee determination.
* Received or administered any disallowed medications within 48 hours prior to study entry.
* At study entry, has any other condition, that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT04582266
Study Brief:
Protocol Section:
NCT04582266