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COVID-19 Household Transmission Study (CO-HOST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445233
Recruitment Status : Active, not recruiting
First Posted : June 24, 2020
Last Update Posted : December 7, 2020
Sponsor:
Collaborator:
North Carolina Translational and Clinical Sciences Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.


Condition or disease
COVID-19

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 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.

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Study Type : Observational
Actual Enrollment : 315 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
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



Primary Outcome Measures :
  1. Number of Households with New SARS-CoV-2 Infection by Day 28 [ Time Frame: 28 days ]
    Secondary household infection rate

  2. Risk Factors Associated with Secondary Household Transmission [ Time Frame: 28 days ]
    Secondary household infection rate risk factors


Secondary Outcome Measures :
  1. 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
nasopharyngeal swabs, nasal swabs, nasal strips, blood samples, saliva samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
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)


Information from the National Library of Medicine

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


Locations
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United States, North Carolina
University of North Carolina Health Care
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
North Carolina Translational and Clinical Sciences Institute
Investigators
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Principal Investigator: Jessica Lin, MD, MSCR UNC-Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04445233    
Other Study ID Numbers: 20-0982
550KR242023 ( Other Grant/Funding Number: NIH )
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Household
COVID-19
Coronavirus
Infection
Transmission
SARS-CoV-2
Nasopharyngeal
Nasal Swabs