Official Title
Duke Shared Data and Specimen Repository Regarding COVID-19 Patients
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.

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.

Recruiting
COVID-19
Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
United States
Locations

Duke University Medical Center
Durham, North Carolina, United States

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

Contacts

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

Chris Woods, MD, Principal Investigator
Duke University

Duke University
NCT Number
Keywords
Data Specimen Repository
MeSH Terms
COVID-19