Post COVID-19 Biorepository

Recruiting

• Conditions: Coronavirus Infection

• Registration Number: NCT04885504
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Living patients or their healthcare surrogates will provide informed consent prior to participation in the biorepository. Surrogate decision makers who cannot consent in person will be consented in accordance to the KUMC remote consent guidelines. Biospecimens to be collected include serum, plasma and whole blood. Blood samples will be collected during face-to-face encounters in the Post-COVID-19 clinic within the TUKHS pulmonary clinic or will be coordinated with other outpatient follow-up appointments (including separate procedure/lab-related visits) or separate study visits for ongoing, indepent studies. Samples will be collected at time of consent as well as at potential follow-up visits at approximately 3, 6, 12, and 12 months from enrollment. Blood samples will be processed, aliquoted, and stored at -80°C. A portion of the blood samples will be kept for DNA and RNA isolation, and a portion of plasma collected might be utilized to isolate peripheral blood mononuclear cells. Biospecimens will be labeled with the patient's study ID number, date of sample processing, and specimen type. Biospecimens will be stored through the duration of the study. If the patient chooses to withdraw consent, his or her samples in the biorepository will be destroyed. Biospecimens that have been previously used or disseminated will continue to be utilized. Future research may include whole genome testing, and these results will not be shared with the patient or their standard of care physician.

Patient data and historical radiographic imaging from after the date of consent will be collected using TUKHS medical records and stored in RedCap. The data to be collected is outlined in the data collection sheets.

Study Timeline

• Study Start: 2021-02-08
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP).
2. 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.
3. Patient is ≥ 18 years of age or older.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Develop of Patient Registry	From Months 12 to 36	Provide biospecimens and unique patient data to researchers investigating COVID-19 and its recovery. Separate IRB approval will be required for these studies.
Establish a Biorepository	From Enrollment to 24 Months	Establish a collection of biospecimens from patients who have recovered from COVID-19.
Develop Connections in Relation to Post-COVID Infection	From Enrollment to 12 Months	Establish links between biospecimens, individual patient data and radiographic imaging, which will be collected and stored in RedCap.

Trial Locations

Locations (1)

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