COVID-19NCT04368234
Duke COVID-19 Shared Data and Specimen Repository
An observational study of COVID-19, run by Duke University at 1 site in United States.
Trial summary
The purpose of this data repository is to provide a secure and centralized storage location and resource for the collection of essential data and medical specimens, across COVID-19 related protocols at Duke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2020to 30 Apr 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any Duke patient that is receiving treatment for COVID-19.
Subjects will be included in this data repository if they meet the enrollment criteria of any linked/participating IRB-approved protocol, or if they are not enrolled in another COVID-related study but meet one of the following inclusion criteria:
- Suspected novel Coronavirus (nCoV) infection (Person Under Investigation) and/or
- Laboratory proven acute novel Coronavirus (nCoV) infection and/or
- Primary admitting diagnosis of nCoV infection
Studies will include:
- Any COVID-19 clinical research studies recruiting Duke patients
- Excludes: protocols sharing non-consented EHR data with national/international repositories and studies that are recruiting community participants
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Duke Shared Data and Specimen Repository Regarding COVID-19 Patients
The purpose of this data repository is to provide a secure and centralized storage location and resource for the collection of essential data and medical specimens, across COVID-19 related protocols at Duke.
Read the detailed description
The aim of this data repository is to provide a secure and centralized storage location and resource for the collection of core variables of interest, as well as the retaining of relevant patient samples, across COVID-19 related protocols at Duke. The core data variables were in-part selected to specifically match those agreed upon by Academic Medical Centers across the U.S., with the intention of aiding the efficiency and effectiveness of de-identified data reuse for population-level research. An additional benefit is that centralized, shared data storage of demographic and longitudinal variables will reduce subject burden, as many questions will now only need to be asked once, rather than each time a given subject joins another COVID-19 related study at Duke.
This shared data and bio-repository project will house all the core data for all patients with COVID-19 (or suspected cases), as well as individual participants ICFs for all other participating COVID-19 studies enrolling Duke patients. Each participating study will have its own separate IRB approved protocol. Samples may be either collected specifically by the protocol, or include left-over clinical samples from the testing and treatment of patients with COVID-19 at Duke.
- Conditions
- COVID-19
- Keywords
- Data Specimen Repository
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Patients | Any Duke patient that is being treated for COVID-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of data repository to provide a secure, centralized storage location for COVID-19 related specimens
This shared data and bio-repository project will house all the core data for all patients with COVID-19 (or suspected cases), as well as individual participant's Informed Consent Forms for all other participating COVID-19 studies enrolling Duke patients. Each participating study will have its own separate IRB approved protocol. Samples may be either collected specifically by the protocol, or include left-over clinical samples from the testing and treatment of patients with COVID-19 at Duke.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start18 Apr 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 100,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Woods, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368234
- Sponsor's protocol ID
- Pro00105316
- Status last verified
- Sep 2026
- First submitted
- 27 Apr 2020
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duke Shared Data and Specimen Repository Regarding COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04368234
- Acronym / sponsor ID
- Pro00105316
- Conditions
- COVID-19
- Keywords
- Data Specimen Repository
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 18 Apr 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 29 Apr 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.
The purpose of this data repository is to provide a secure and centralized storage location and resource for the collection of essential data and medical specimens, across COVID-19 related protocols at Duke.
Detailed description
The aim of this data repository is to provide a secure and centralized storage location and resource for the collection of core variables of interest, as well as the retaining of relevant patient samples, across COVID-19 related protocols at Duke. The core data variables were in-part selected to specifically match those agreed upon by Academic Medical Centers across the U.S., with the intention of aiding the efficiency and effectiveness of de-identified data reuse for population-level research. An additional benefit is that centralized, shared data storage of demographic and longitudinal variables will reduce subject burden, as many questions will now only need to be asked once, rather than each time a given subject joins another COVID-19 related study at Duke.
This shared data and bio-repository project will house all the core data for all patients with COVID-19 (or suspected cases), as well as individual participants ICFs for all other participating COVID-19 studies enrolling Duke patients. Each participating study will have its own separate IRB approved protocol. Samples may be either collected specifically by the protocol, or include left-over clinical samples from the testing and treatment of patients with COVID-19 at Duke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Patients | – | –Any Duke patient that is being treated for COVID-19. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any Duke patient that is receiving treatment for COVID-19.
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
Development of data repository to provide a secure, centralized storage location for COVID-19 related specimens
Time frame: Up to 5 years
This shared data and bio-repository project will house all the core data for all patients with COVID-19 (or suspected cases), as well as individual participant's Informed Consent Forms for all other participating COVID-19 studies enrolling Duke patients. Each participating study will have its own separate IRB approved protocol. Samples may be either collected specifically by the protocol, or include left-over clinical samples from the testing and treatment of patients with COVID-19 at Duke.
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 3 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Chris Woods, MD principal investigator
Duke University
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 Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. 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?
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?
Development of data repository to provide a secure, centralized storage location for COVID-19 related specimens (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.