COVID-19 Biorepository

May 19, 2026 updated by: Leslie Spikes, MD, University of Kansas Medical Center
Establish a COVID-19 biorepository to aid in developing our knowledge of the disease.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

While SARS-CoV-2 has some similarities to the SARS-CoV pathogen that led to an epidemic in 2002 and 2003, there is much about the epidemiology, pathogenesis, clinical presentation, diagnosis, and treatment of the novel virus that remains unknown.3 Additional research is needed to explore the nature of the virus, its spectrum of disease, and potential therapies to combat its spread. The aim of this project will be to establish a biorepository of blood samples from patients infected with SARS-CoV-2 that can then be used by investigators to expand our understanding of COVID-19 and its treatment and, in turn, improve patient outcomes.

The COVID-19 biorepository will accomplish the following specific aims:

  1. Establish a collection of biospecimens from patients with COVID-19.
  2. Establish a link between biospecimens and longitudinal individual patient data, which will be collected and stored in RedCap.
  3. Provide biospecimens and unique patient data to researchers investigating COVID-19. Separate IRB approval will be needed for these studies.

Study Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

COVID-19-positive patients

Description

Inclusion Criteria:

  • The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP).
  • The participant has a diagnosis of COVID-19 confirmed by COVID-19 PCR.
  • Patient is 18 years of age or older.

Exclusion Criteria:

  • Participant declines to participate (living patients only)
  • Participant or healthcare surrogate is unable to provide informed consent (living patients only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biospecimen Collection
Time Frame: From Enrollment to 3 Months
Establish a collection of biospecimens from patients with COVID-19.
From Enrollment to 3 Months
Establishing Connections
Time Frame: From Enrollment to 3 Months
Establish a link between biospecimens and longitudinal individual patient data
From Enrollment to 3 Months
Continuing COVID Research
Time Frame: From Enrollment to 3 Months
Provide biospecimens and unique patient data to researchers investigating COVID-19
From Enrollment to 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Leslie A Spikes, MD, Assistant Professor of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2020

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

September 26, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY#00145602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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