COVID-19 Biorepository

Covid-19 Clinical Trial

Official title:

COVID-19 Biorepository

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04568148
• Other study ID #: STUDY#00145602
• Status: Recruiting
• Start date: April 15, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: University of Kansas Medical Center
• Contact: Luigi R Boccardi, BS
• Phone: 9135884022
• Email: lboccardi[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronavirus
• COVID
• Covid-19
• SARS-CoV 2

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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