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 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT04445233
Eligibility Criteria:
Inclusion Criteria:
COVID-positive index cases (COV):
* Any patient greater than or equal to18 years of age with a positive qualitative nasopharyngeal or nasal swab for SARS-CoV-2 obtained at UNC Hospitals or an outpatient clinic
* COVID-19 diagnosis by positive NP swab
* Willingness to self-isolate at home for a 14-day period
* Living with at least one household contact who is also willing to consent to study follow-up
* Living within reasonable driving distance (\<1 hour) suitable for home visits by study team
Household contact of COVID-positive index case (COV-HC):
• Household contacts greater than 1 year of age currently living in the same home as the COVID-positive index case without plans to leave to live elsewhere through the end of the 28-day study.
Exclusion Criteria:
COVID-positive index cases (COV): None
Household contact of COVID-positive index case (COV-HC):
• Previously participated in this study (as index case or household contact)
For the extension part of CO-HOST, study participants greater than 65 years of age who tested positive for acute SAR-CoV-2 infection by PCR or seroconversion (antibody status became positive) during their participation in the first month of the study, will be eligible. They will be excluded if they previously received immunologic therapy (i.e., exogenous anti-SARS-CoV-2 monoclonal antibodies) for COVID-19 infection.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT04445233
Study Brief:
Protocol Section:
NCT04445233