COVID-19YMHNCT05589376
You and Me Healthy
An observational study of COVID-19, run by Duke University at 3 sites in United States.
Trial summary
The You and Me Healthy Registry provides a resource for collecting information on people currently living in the United States. The overall goal of the Registry is to create and engage a community of people who may be eligible for participation in future research studies aiming to answer research questions about… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 20,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Sep 2022to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The You and Me Healthy Registry will include children and adults currently living across the United States.
Who may be able to join
- Currently residing in the United States
- Age ≥ 2 (for minors, parents/legal guardian will be the primary point of contact)
- Able to speak and read in the language used in the surveys/assessments available
Who cannot join
- There are no specific exclusion criteria for this registry
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Hamilton County
Chattanooga, Tennessee, 37341
Greenville Pitt County
Greenville, North Carolina, 27705
Merced County
Merced, California, 95340
About this study
Official title: You and Me Healthy Registry Study
The You and Me Healthy Registry provides a resource for collecting information on people currently living in the United States. The overall goal of the Registry is to create and engage a community of people who may be eligible for participation in future research studies aiming to answer research questions about COVID-19 and other conditions.
Read the detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus responsible for the COVID-19 pandemic. In the United States (US) up until January 2022, > 60 million people have been infected with the SARS-CoV-2 virus and >800,000 died, with infections and deaths disproportionally affecting populations that have been historically marginalized1. Wide disparities also persist by race/ethnicity and age with COVID-19 testing and vaccine uptake related to social and structural factors, resulting in adverse health consequences.
As public health measures have scaled up, mitigation strategies are increasingly being considered to reduce community spread of infection. These measures include rapid-result at-home tests, protective measures (masking, social distancing, increased hygiene), treatments, and contact-tracing and isolation. As the pandemic evolves, new discoveries, technologies, and strategies to combat COVID-19 are being implemented with limited backing of research data. To address this continued unmet public health need, the You and Me Healthy registry is being created to engage community members and serve as a way to provide and collect information from all people who are interested in engaging in upcoming research studies, including those related to COVID-19.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants enrolled in the Virtual Community
Create a virtual community of people in the United States interested in engaging in upcoming research studies, including those related to COVID-19; By asking them to sign -up and join the registry- they provide their email address and through that they will receive information on upcoming research and information on health issues occurring in their community.
Measured: Through study completion; 5 years
Number of participants included in the Dataset
Create a dataset of health-related measurements, risk factors, and outcomes for future; analysis and in support of upcoming research studies; through collecting survey responses via questioners.
Measured: Through study completion; 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start8 Sep 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 20,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Hornik, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589376
- Sponsor's protocol ID
- Pro00110716
- Acronym
- YMH
- Status last verified
- Nov 2025
- First submitted
- 28 Sep 2022
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Agostino EM, Granados I, Abbott-Grimes P, Brown-Lowery C, Damman A, Fadika T, Ward M, Cooper M, Sato J, Kasper J, Vizcaino T, Gray W, Swart A, Sparling A, Corchado CG, Hornik CP. Community partnership lessons learned from the You & Me: Test and Treat study. BMC Public Health. 2025 Jun 6;25(1):2115. doi: 10.1186/s12889-025-23216-y.
PubMed 40481451
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- You and Me Healthy Registry Study
- ClinicalTrials.gov ID
- NCT05589376
- Acronym / sponsor ID
- YMH / Pro00110716
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Oct 2022 (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.
The You and Me Healthy Registry provides a resource for collecting information on people currently living in the United States. The overall goal of the Registry is to create and engage a community of people who may be eligible for participation in future research studies aiming to answer research questions about COVID-19 and other conditions.
Detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus responsible for the COVID-19 pandemic. In the United States (US) up until January 2022, > 60 million people have been infected with the SARS-CoV-2 virus and >800,000 died, with infections and deaths disproportionally affecting populations that have been historically marginalized1. Wide disparities also persist by race/ethnicity and age with COVID-19 testing and vaccine uptake related to social and structural factors, resulting in adverse health consequences.
As public health measures have scaled up, mitigation strategies are increasingly being considered to reduce community spread of infection. These measures include rapid-result at-home tests, protective measures (masking, social distancing, increased hygiene), treatments, and contact-tracing and isolation. As the pandemic evolves, new discoveries, technologies, and strategies to combat COVID-19 are being implemented with limited backing of research data. To address this continued unmet public health need, the You and Me Healthy registry is being created to engage community members and serve as a way to provide and collect information from all people who are interested in engaging in upcoming research studies, including those related to COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The You and Me Healthy Registry will include children and adults currently living across the United States.
Key inclusion criteria (3 listed)
- Currently residing in the United States
- Age ≥ 2 (for minors, parents/legal guardian will be the primary point of contact)
- Able to speak and read in the language used in the surveys/assessments available
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants enrolled in the Virtual Community
Time frame: Through study completion; 5 years
Create a virtual community of people in the United States interested in engaging in upcoming research studies, including those related to COVID-19; By asking them to sign -up and join the registry- they provide their email address and through that they will receive information on upcoming research and information on health issues occurring in their community.
Number of participants included in the Dataset
Time frame: Through study completion; 5 years
Create a dataset of health-related measurements, risk factors, and outcomes for future; analysis and in support of upcoming research studies; through collecting survey responses via questioners.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Derived from this study: PubMed 40481451D'Agostino EM, Granados I, Abbott-Grimes P, Brown-Lowery C, Damman A, Fadika T, Ward M, Cooper M, Sato J, Kasper J, Vizcaino T, Gray W, Swart A, Sparling A, Corchado CG, Hornik CP. Community partnership lessons learned from the You & Me: Test and Treat study. BMC Public Health. 2025 Jun 6;25(1):2115. doi: 10.1186/s12889-025-23216-y.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)
COVID-19, SARS-CoV-2 Infection, RSV
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.
Christoph Hornik principal investigator
Duke University
3 sites 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 Duke University at 3 sites 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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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 participants enrolled in the Virtual Community (time frame: Through study completion; 5 years). 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 NCT05589376, 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 26 Nov 2025.