Post COVID-19 Biorepository

NCT04885504 | Recruiting

• 1 other identifier: STUDY#00146337
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Establish a biorepository, clinical data registry, and radiographic image database from individuals who were COVID positive at one time and are being seen for outpatient follow-up or a separate study visit.

Conditions

Coronavirus Infection

Outcome Measures

Primary Outcomes (3)

• Establish a Biorepository

  Establish a collection of biospecimens from patients who have recovered from COVID-19.

  From Enrollment to 24 Months

• Develop Connections in Relation to Post-COVID Infection

  Establish links between biospecimens, individual patient data and radiographic imaging, which will be collected and stored in RedCap.

  From Enrollment to 12 Months

• Develop of Patient Registry

  Provide biospecimens and unique patient data to researchers investigating COVID-19 and its recovery. Separate IRB approval will be required for these studies.

  From Months 12 to 36

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participant will be recruited from the population of recovering COVID-19 patients seen in the Post-COVID-19 clinic within the TUKHS pulmonary clinic or who are scheduled for other outpatient appointments or unrelated study visits for separate, ongoing studies at TUKHS.

You may qualify if:

• 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 previous diagnosis of COVID-19 confirmed by COVID-19 PCR or antibody testing and is being seen for outpatient follow-up.
• Patient is ≥ 18 years of age or older.

You may not qualify if:

• Participant declines to participate.
• Participant or healthcare surrogate is unable to provide informed consent.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Future projects might include genetic testing. Your sample may be sent to a lab for genetic testing.

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Leslie A Spikes, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Luigi R Boccardi, Ed.D., MPH

  University of Kansas Medical Center

  STUDY DIRECTOR

Central Study Contacts

Adam M Ruff, BS

CONTACT

9135743932; aruff@kumc.edu

Luigi R Boccardi, Ed.D., MPH

CONTACT

9135884022; lboccardi@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 13, 2021
• Study Start: February 8, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 15, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

US (1)