Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-29 @ 2:03 AM
Study NCT ID:
NCT04885504
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2021-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post COVID-19 Biorepository
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
Post COVID-19 Biorepository
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: