COVID-19 Biorepository

Active, not recruiting

• Conditions: Covid-19; SARS-CoV 2; Coronavirus; COVID

• Registration Number: NCT04568148
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

Establish a COVID-19 biorepository to aid in developing our knowledge of the disease.

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 Timeline

• Study Start: 2020-04-15
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-09-26
• Study First Posted: 2020-09-29
• Primary Completion: 2023-12-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States