Duke COVID-19 Shared Data and Specimen Repository

NCT04368234 | Active Not Recruiting

• 1 other identifier: Pro00105316
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Data Specimen Repository

Outcome Measures

Primary Outcomes (1)

• Development of data repository to provide a secure, centralized storage location for COVID-19 related specimens

  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.

  Up to 5 years

Study Arms (1)

COVID-19 Patients

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any Duke patient that is receiving treatment for COVID-19.

You may qualify if:

• Suspected novel Coronavirus (nCoV) infection (Person Under Investigation) and/or
• Laboratory proven acute novel Coronavirus (nCoV) infection and/or
• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chris Woods, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: April 18, 2020
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)