Clinical trial NCT04885504: Post COVID-19 Biorepository
Official title: Post COVID-19 Biorepository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronavirus Infection
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Establish a Biorepository
timeFrame: From Enrollment to 24 Months
measure: Develop Connections in Relation to Post-COVID Infection
timeFrame: From Enrollment to 12 Months
measure: Develop of Patient Registry
timeFrame: From Months 12 to 36
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Leslie A Spikes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Luigi R Boccardi, MPH
role: STUDY_DIRECTOR
References: