COVID-19CO-HOSTNCT04445233
COVID-19 Household Transmission Study
An observational study of COVID-19, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID-19 IgM-IgG Rapid Test
- Type of treatment
- Medical device
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2020to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Health Care
Chapel Hill, North Carolina, 27514
About this study
Official title: The COVID-19 Household Transmission Study (CO-HOST) - Epidemiology of SARS-CoV-2 Transmission Within the Household
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.
Read the 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.
As part of the extension to the study, the study team will come back to previous enrolled participants' houses for a single visit at about 6 months from when they enrolled in this study. If these participants prefer, they could come to UNC for this visit instead. At this visit, the study team will collect these participants' blood sample and draw up to 10 tsp of blood. The study team will also perform a COVID-19 rapid antibody test, which uses two-three drops of blood from a finger prick. These participants will also be asked to complete a short (5-minute) online questionnaire.
After this visit, if these participants have not already been vaccinated, then the study team will give them the option to participate in one more visit at their house or at UNC within 1-3 months after they receive the COVID vaccine to collect a blood sample (up to 10 tsp). The study team will also repeat the rapid antibody test with another finger prick.
- Conditions
- COVID-19
- Being tested
- COVID-19 IgM-IgG Rapid Test
- Keywords
- Household, COVID-19, Coronavirus, Infection, Transmission, SARS-CoV-2, Nasopharyngeal, Nasal Swabs
- Medical subject headings
- COVID-19, Coronavirus Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 IgM-IgG Rapid TestDevice
Used to detect the IgG and IgM antibodies of the novel coronavirus in human whole blood (capillary or venous), serum, or plasma.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: COVID-19 IgM-IgG Rapid Test | |
| 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 Receives: Device: COVID-19 IgM-IgG Rapid Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Households with New SARS-CoV-2 Infection by Day 28
Secondary household infection rate
Measured: 28 days
Risk Factors Associated with Secondary Household Transmission
Secondary household infection rate risk factors
Measured: 28 days
Secondary outcomes (1)
Number of Self-Swab Tests vs. NP Swabs at Day 1 with Detectable Viral Load
Sensitivity of self-collected nasal swabs
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start29 Apr 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Jessica Lin, MD, MSCR, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445233
- Sponsor's protocol ID
- 20-0982
- Other IDs
- 550KR242023
- Acronym
- CO-HOST
- Status last verified
- Apr 2022
- First submitted
- 22 Jun 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
Churiwal M, Tompkins K, Streeter G, Litel C, Mason S, Lin K, Muller M, Chhetri S, Belvin T, Lin FC, Basham C, Whittelsey M, Rapp T, Premkumar L, Cerami C, Lin JT. Symptom burden, viral load, and antibody response to ancestral SARS-CoV-2 strain [D614G] in an outpatient household cohort. PLoS One. 2026 Feb 5;21(2):e0313467. doi: 10.1371/journal.pone.0313467. eCollection 2026.
PubMed 41642857
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COVID-19 Household Transmission Study (CO-HOST) - Epidemiology of SARS-CoV-2 Transmission Within the Household
- ClinicalTrials.gov ID
- NCT04445233
- Acronym / sponsor ID
- CO-HOST / 20-0982
- Conditions
- COVID-19
- Keywords
- Household, COVID-19, Coronavirus, Infection, Transmission, SARS-CoV-2, Nasopharyngeal, Nasal Swabs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
As part of the extension to the study, the study team will come back to previous enrolled participants' houses for a single visit at about 6 months from when they enrolled in this study. If these participants prefer, they could come to UNC for this visit instead. At this visit, the study team will collect these participants' blood sample and draw up to 10 tsp of blood. The study team will also perform a COVID-19 rapid antibody test, which uses two-three drops of blood from a finger prick. These participants will also be asked to complete a short (5-minute) online questionnaire.
After this visit, if these participants have not already been vaccinated, then the study team will give them the option to participate in one more visit at their house or at UNC within 1-3 months after they receive the COVID vaccine to collect a blood sample (up to 10 tsp). The study team will also repeat the rapid antibody test with another finger prick.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COV Participants | – | Device: COVID-19 IgM-IgG Rapid TestCOVID-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 | – | Device: COVID-19 IgM-IgG Rapid TestHousehold 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 |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- COVID-positive index cases (COV): None
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 IgM-IgG Rapid TestUsed to detect the IgG and IgM antibodies of the novel coronavirus in human whole blood (capillary or venous), serum, or plasma. | Device | COV Participants, COV-HC Participants |
Primary outcome
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
1 secondary outcome
Number of Self-Swab Tests vs. NP Swabs at Day 1 with Detectable Viral Load
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 41642857Churiwal M, Tompkins K, Streeter G, Litel C, Mason S, Lin K, Muller M, Chhetri S, Belvin T, Lin FC, Basham C, Whittelsey M, Rapp T, Premkumar L, Cerami C, Lin JT. Symptom burden, viral load, and antibody response to ancestral SARS-CoV-2 strain [D614G] in an outpatient household cohort. PLoS One. 2026 Feb 5;21(2):e0313467. doi: 10.1371/journal.pone.0313467. eCollection 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Lin, MD, MSCR principal investigator
UNC-Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Households with New SARS-CoV-2 Infection by Day 28 (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04445233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.