Duke COVID-19 Shared Data and Specimen Repository

NCT ID: NCT04368234

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-18

Study Completion Date

2028-04-30

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 Patients

Any Duke patient that is being treated for COVID-19.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Woods, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00105316

Identifier Type: -

Identifier Source: org_study_id

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