COVID-19 Biorepository

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04568148

Collaborator

(none)

Enrollment

Location

20.5

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid-19 SARS-CoV 2 Coronavirus COVID

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:

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

COVID-19 Biorepository

Actual Study Start Date :

Apr 15, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Leslie Spikes, MD, Assistant Professor, University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT04568148

Other Study ID Numbers:

STUDY#00145602

First Posted:

Sep 29, 2020

Last Update Posted:

Sep 29, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Sep 29, 2021