COVID-19 Household Transmission Study (CO-HOST)
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|ClinicalTrials.gov Identifier: NCT04445233|
Recruitment Status : Active, not recruiting
First Posted : June 24, 2020
Last Update Posted : December 7, 2020
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.
|Condition or disease|
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 and female, ≥ 1 year of age.
This study will test and follow persons quarantined at home after testing positive for SARS-CoV-2 (COV) and their household members.
The CO-HOST mobile nurse initiates a home visit to the home of the COVID-19 index case after they and their household members (COV-HC) verbally express interest in the study and provide consent or assent as appropriate. At the first visit, nasopharyngeal (NP) swabs and blood are collected from COV and all members of the household (COV-HC) to determine infection status. Additional samples (nasal swabs, saliva, nasal strips), both nurse-collected and self-collected, may also be collected from COV and COV-HC. The nurse will provide specific instructions and training on how to perform self-collected swabs.
Every week, thereafter, COV-HC are tested during the 28 days of the study. If home visits are not possible, then participants will perform self-collected swabs for testing. If COV-HC develops symptoms, they will be referred per standard of care (SOC).
If COV or COV-HC are hospitalized, they will remain in the study for outcome assessment, but without further sample collections.
|Study Type :||Observational|
|Actual Enrollment :||315 participants|
|Official Title:||The COVID-19 Household Transmission Study (CO-HOST) - Epidemiology of SARS-CoV-2 Transmission Within the Household|
|Actual Study Start Date :||April 29, 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
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
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
- Number of Households with New SARS-CoV-2 Infection by Day 28 [ Time Frame: 28 days ]Secondary household infection rate
- Risk Factors Associated with Secondary Household Transmission [ Time Frame: 28 days ]Secondary household infection rate risk factors
- Number of Self-Swab Tests vs. NP Swabs at Day 1 with Detectable Viral Load [ Time Frame: 1 day ]Sensitivity of self-collected nasal swabs
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445233
|United States, North Carolina|
|University of North Carolina Health Care|
|Chapel Hill, North Carolina, United States, 27514|
|Principal Investigator:||Jessica Lin, MD, MSCR||UNC-Chapel Hill|