Status:
COMPLETED
COVID-19 Household Transmission Study
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
North Carolina Translational and Clinical Sciences Institute
Conditions:
COVID-19
Eligibility:
All Genders
1+ years
Brief Summary
This study will test and follow persons quarantined at home after testing positive for SARS-CoV-2 (COV) aged 18 years and older and their household members aged 1 year and older. The purpose of this ...
Detailed Description
This study will enroll approximately 200 men and women ≥ 18 years of age who are SARS-CoV-2 PCR positive undergoing home quarantine \& approximately 200-1500 immediate household contacts, both male an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT04445233
Start Date
April 29 2020
End Date
September 1 2021
Last Update
April 27 2022
Active Locations (1)
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1
University of North Carolina Health Care
Chapel Hill, North Carolina, United States, 27514