Duke COVID-19 Shared Data and Specimen Repository
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04368234 |
Recruitment Status :
Recruiting
First Posted : April 29, 2020
Last Update Posted : July 23, 2020
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Condition or disease |
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COVID-19 |
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 Type : | Observational [Patient Registry] |
Estimated Enrollment : | 100000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 5 Years |
Official Title: | Duke Shared Data and Specimen Repository Regarding COVID-19 Patients |
Actual Study Start Date : | April 18, 2020 |
Estimated Primary Completion Date : | April 30, 2025 |
Estimated Study Completion Date : | April 30, 2025 |
Group/Cohort |
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COVID-19 Patients
Any Duke patient that is being treated for COVID-19.
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- 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.
Biospecimen Retention: Samples With DNA

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.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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): NCT04368234
Contact: Lynn Sutton | 919-668-8925 | lynn.sutton@duke.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Lynn Sutton 919-668-8925 lynn.sutton@duke.edu |
Principal Investigator: | Chris Woods, MD | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT04368234 |
Other Study ID Numbers: |
Pro00105316 |
First Posted: | April 29, 2020 Key Record Dates |
Last Update Posted: | July 23, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Data Specimen Repository |