COVID-19 Household Transmission Study
CO-HOST
The COVID-19 Household Transmission Study (CO-HOST) - Epidemiology of SARS-CoV-2 Transmission Within the Household
2 other identifiers
observational
315
1 country
1
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 research study is to understand how often COVID-19 (Coronavirus Disease 2019) spreads in the household when someone who tests positive for the virus self-isolates at home. The purpose of the extension part of the study is to help us understand long-term immunity to COVID-19. We are interested in how our immune system might still protect us from COVID-19 even after antibody levels decrease or are no longer detected. We are also interested in how immunity to COVID-19 is different in kids vs. adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2020
CompletedFirst Submitted
Initial submission to the registry
June 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedApril 27, 2022
April 1, 2022
1.3 years
June 22, 2020
April 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Households with New SARS-CoV-2 Infection by Day 28
Secondary household infection rate
28 days
Risk Factors Associated with Secondary Household Transmission
Secondary household infection rate risk factors
28 days
Secondary Outcomes (1)
Number of Self-Swab Tests vs. NP Swabs at Day 1 with Detectable Viral Load
1 day
Study Arms (2)
COV Participants
COVID-positive index cases (COV): Participants who are greater than or equal to 18 years of age who test positive for COVID-19 by positive NP swab
COV-HC Participants
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
Interventions
Used to detect the IgG and IgM antibodies of the novel coronavirus in human whole blood (capillary or venous), serum, or plasma.
Eligibility Criteria
Men and women ≥ 18 years of age who are SARS-CoV-2 PCR positive undergoing home quarantine \& immediate household contacts, both male and female, ≥ 1 year of age will all be asked to participate in the study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina Health Care
Chapel Hill, North Carolina, 27514, United States
Biospecimen
nasopharyngeal swabs, nasal swabs, nasal strips, blood samples, saliva samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Lin, MD, MSCR
UNC-Chapel Hill
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2020
First Posted
June 24, 2020
Study Start
April 29, 2020
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
April 27, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 12-24 months after publication
- Access Criteria
- Investigators/researchers who propose to use study data will need to have IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC.
De-identified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator/researcher who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.