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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT04582903
Eligibility Criteria:
* INCLUSION CRITERIA:
Participants enrolled onto this protocol must meet all of the following criteria:
1. Aged 0-99 years (including viable neonates).
2. Meets one of the following criteria:
1. Patient with a known or suspected diagnosis of SARS-CoV-2 infection (past or current), typically but not always supported by a positive PCR test for viral RNA;
2. Individual who has remained uninfected with negative SARS-CoV-2 serologies despite heavy or extensive COVID-19 exposure in the workplace or home environment; or
3. Biological relative of a participant being studied under this protocol. Relatives may be biological mother, father, siblings, children, grandparents, aunts, uncles, or first cousins.
3. For individuals considered for enrollment as uninfected individuals and biological relatives, able to provide informed consent.
4. Willing to allow genetic testing.
5. Willing to allow storage of samples and data for future research.
EXCLUSION CRITERIA:
Individuals meeting any of the following criteria will be excluded from study participation:
1\. Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Since patients can be concurrently infected with multiple respiratory viruses, positive testing for other viruses such as rhinovirus, influenza virus, etc., does not exclude an individual from study participation where there remains a high clinical suspicion of COVID-19 infection despite negative testing for SARS-CoV-2.
Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
99 Years
Study:
NCT04582903
Study Brief:
Protocol Section:
NCT04582903