Covid-19NCT04568148
COVID-19 Biorepository
An observational study of Covid-19 and SARS-CoV 2, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Establish a COVID-19 biorepository to aid in developing our knowledge of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, SARS-CoV 2, Coronavirus
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: COVID-19-positive patients
Who may be able to join
- 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.
Who cannot join
- Participant declines to participate (living patients only)
- Participant or healthcare surrogate is unable to provide informed consent (living patients only)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Establish a COVID-19 biorepository to aid in developing our knowledge of the disease.
Read the detailed 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:
- Establish a collection of biospecimens from patients with COVID-19.
- Establish a link between biospecimens and longitudinal individual patient data, which will be collected and stored in RedCap.
- Provide biospecimens and unique patient data to researchers investigating COVID-19. Separate IRB approval will be needed for these studies.
- Conditions
- Covid-19, SARS-CoV 2, Coronavirus, COVID
- Medical subject headings
- COVID-19, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Biospecimen Collection
Establish a collection of biospecimens from patients with COVID-19.
Measured: From Enrollment to 3 Months
Establishing Connections
Establish a link between biospecimens and longitudinal individual patient data
Measured: From Enrollment to 3 Months
Continuing COVID Research
Provide biospecimens and unique patient data to researchers investigating COVID-19
Measured: From Enrollment to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start15 Apr 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Spikes, MD, University of Kansas Medical Center
- Investigators
- Leslie A Spikes, MD, Principal investigator, Assistant Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568148
- Sponsor's protocol ID
- STUDY#00145602
- Status last verified
- May 2026
- First submitted
- 15 Apr 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Biorepository
- ClinicalTrials.gov ID
- NCT04568148
- Acronym / sponsor ID
- STUDY#00145602
- Conditions
- Covid-19, SARS-CoV 2, Coronavirus, COVID
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Establish a COVID-19 biorepository to aid in developing our knowledge of the disease.
Detailed 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:
- Establish a collection of biospecimens from patients with COVID-19.
- Establish a link between biospecimens and longitudinal individual patient data, which will be collected and stored in RedCap.
- Provide biospecimens and unique patient data to researchers investigating COVID-19. Separate IRB approval will be needed for these studies.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COVID-19-positive patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Participant declines to participate (living patients only)
- Participant or healthcare surrogate is unable to provide informed consent (living patients only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biospecimen Collection
Time frame: From Enrollment to 3 Months
Establish a collection of biospecimens from patients with COVID-19.
Establishing Connections
Time frame: From Enrollment to 3 Months
Establish a link between biospecimens and longitudinal individual patient data
Continuing COVID Research
Time frame: From Enrollment to 3 Months
Provide biospecimens and unique patient data to researchers investigating COVID-19
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie A Spikes, MD principal investigator
Assistant Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and SARS-CoV 2, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biospecimen Collection (time frame: From Enrollment to 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.