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COVID-19 Household Transmission Study

COVID-19 Household Transmission Study

Recruiting
1 years and older
All
Phase N/A

Overview

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.

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.

Eligibility

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)

Study details
    Covid 19

NCT04445233

University of North Carolina, Chapel Hill

5 August 2020

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