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Duke COVID-19 Shared Data and Specimen Repository

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ClinicalTrials.gov Identifier: NCT04368234
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief 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.

Condition or disease
COVID-19

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
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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
Groups and Cohorts
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Group/Cohort
COVID-19 Patients
Any Duke patient that is being treated for COVID-19.


Outcome Measures
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Primary Outcome Measures :
  1. 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
Biological specimens may include, but are not limited to, tissue, blood, urine, sputum, feces, genetic, and/or cell samples.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any Duke patient that is receiving treatment for COVID-19.
Criteria

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:

  1. Suspected novel Coronavirus (nCoV) infection (Person Under Investigation) and/or
  2. Laboratory proven acute novel Coronavirus (nCoV) infection and/or
  3. 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Lynn Sutton 919-668-8925 lynn.sutton@duke.edu

Locations
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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   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Chris Woods, MD Duke University
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Data Specimen Repository