Duke COVID-19 Shared Data and Specimen Repository
|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
|Condition or disease|
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|
|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|
Any Duke patient that is being treated for COVID-19.
- 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
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 Suttonfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Lynn Sutton 919-668-8925 email@example.com|
|Principal Investigator:||Chris Woods, MD||Duke University|