Clinical trial NCT04368234: Duke COVID-19 Shared Data and Specimen Repository
Official title: Duke Shared Data and Specimen Repository Regarding COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: Data Specimen Repository
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any Duke patient that is receiving treatment for COVID-19.

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.

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

Primary outcomes:
measure: Development of data repository to provide a secure, centralized storage location for COVID-19 related specimens
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Chris Woods, MD
role: PRINCIPAL_INVESTIGATOR
References: