COVID-19NCT05595837
Immune Registry for Organ Transplantation From COVID Positive Donors.
An observational study of COVID-19 and Organ Transplant, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to collect data generated by standard clinical practice to determine the short term and long term clinical outcomes of recipients of solid organ transplantation from COVID-19 infected donors and compare it to recipients with organ transplant from COVID-19 negative donors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Organ Transplant
- What is being tested?
- Standard organ transplant
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2022to 20 Jul 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Solid organ transplant recipients
Who may be able to join
- Adult (>18 years old) male and female solid organ transplant recipients
Who cannot join
- Absence of informed consent for the clinical protocol and the registry.
- Prisoners will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this study is to collect data generated by standard clinical practice to determine the short term and long term clinical outcomes of recipients of solid organ transplantation from COVID-19 infected donors and compare it to recipients with organ transplant from COVID-19 negative donors.
Read the detailed description
To advance science, it is helpful for researchers to share information. They do this by putting data or biospecimens into one or more scientific databases (called registries or repositories), where it is stored along with information from other studies. Researchers can then study the information in other ways and combine information from many studies to learn even more. The researchers are asking for permission to store and share personal information in a research registry to help research studies in the future. The information will be available for any research question, such as research to understand what causes certain diseases in patients with solid organ transplant, development of new scientific methods, or the study of where different groups of people may have come from.
Information from participant's medical chart will be securely stored in the VCU database. This will include donor information (including COVID test results, radiologic findings, symptoms, treatments, cause of death etc.) as well as recipient information (including demographics, labs, biopsy findings if any, length of hospital stay, COVID transmission, graft function, immunosuppression, post-transplant complications and long term clinical outcomes like patient and graft survival, etc.). Data will be collected during routine clinical care.
The study will include the following tests:
- Pre transplant COVID-19 PCR on the nasal swab (as standard transplant protocol), serum COVID-19 specific T-cell immune response, and serum COVID-19 spike antibody as a study protocol in all the recipients.
- Posttransplant COVID-19 spike antibody in the serum around 4 weeks after the completion of induction Thymoglobulin as a study protocol in all the recipients.
- Daily COVID-19 PCR in serum from post-operative day 1 till post-operative day 4 as a study protocol in the recipients with organ transplant from COVID-19 positive donors.
- Posttransplant COVID-19 PCR nasal swab once around one-week post-transplant as study protocol in the recipients with organ transplant from COVID-19 positive donors.
- COVID-19 T-cell specific immune response will be checked in the recipient's serum at 4 weeks post-transplant as study protocol in all the recipients.
- According to the standard transplant protocol post-transplant donor-specific antibodies will be checked around 2 weeks post transplant and the results will direct the donor-derived cell-free DNA testing in all the recipients.
- Conditions
- COVID-19, Organ Transplant
- Being tested
- Standard organ transplant
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard organ transplantOther
Standard organ transplant procedures and follow up care
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive donors | Not described Receives: Other: Standard organ transplant | |
| COVID-19 negative donors | Not described Receives: Other: Standard organ transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who test positive for COVID-19
Measured: 1 week post transplant
Serum COVID-19 T-cell specific immune response
Blood samples from participants will be tested for the presence or absence of COVID-19 immune response markers, i.e. T-cells. The existence of T-cells will be marked as positive, indicating an immune response in the participant to COVID-19.
Measured: 4 week post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start29 Dec 2022
- Primary completion20 Jul 2025
- Study completion20 Jul 2025
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.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Eurofins
- Responsible party
- Sponsor
- Investigators
- Ambreen Azhar, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595837
- Sponsor's protocol ID
- HM20024454
- Status last verified
- Aug 2025
- First submitted
- 20 Oct 2022
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Registry for Organ Transplantation From COVID Positive Donors.
- ClinicalTrials.gov ID
- NCT05595837
- Acronym / sponsor ID
- HM20024454
- Conditions
- COVID-19, Organ Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Eurofins
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 27 Oct 2022 (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.
The purpose of this study is to collect data generated by standard clinical practice to determine the short term and long term clinical outcomes of recipients of solid organ transplantation from COVID-19 infected donors and compare it to recipients with organ transplant from COVID-19 negative donors.
Detailed description
To advance science, it is helpful for researchers to share information. They do this by putting data or biospecimens into one or more scientific databases (called registries or repositories), where it is stored along with information from other studies. Researchers can then study the information in other ways and combine information from many studies to learn even more. The researchers are asking for permission to store and share personal information in a research registry to help research studies in the future. The information will be available for any research question, such as research to understand what causes certain diseases in patients with solid organ transplant, development of new scientific methods, or the study of where different groups of people may have come from.
Information from participant's medical chart will be securely stored in the VCU database. This will include donor information (including COVID test results, radiologic findings, symptoms, treatments, cause of death etc.) as well as recipient information (including demographics, labs, biopsy findings if any, length of hospital stay, COVID transmission, graft function, immunosuppression, post-transplant complications and long term clinical outcomes like patient and graft survival, etc.). Data will be collected during routine clinical care.
The study will include the following tests:
- Pre transplant COVID-19 PCR on the nasal swab (as standard transplant protocol), serum COVID-19 specific T-cell immune response, and serum COVID-19 spike antibody as a study protocol in all the recipients.
- Posttransplant COVID-19 spike antibody in the serum around 4 weeks after the completion of induction Thymoglobulin as a study protocol in all the recipients.
- Daily COVID-19 PCR in serum from post-operative day 1 till post-operative day 4 as a study protocol in the recipients with organ transplant from COVID-19 positive donors.
- Posttransplant COVID-19 PCR nasal swab once around one-week post-transplant as study protocol in the recipients with organ transplant from COVID-19 positive donors.
- COVID-19 T-cell specific immune response will be checked in the recipient's serum at 4 weeks post-transplant as study protocol in all the recipients.
- According to the standard transplant protocol post-transplant donor-specific antibodies will be checked around 2 weeks post transplant and the results will direct the donor-derived cell-free DNA testing in all the recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive donors | – | Other: Standard organ transplant |
| COVID-19 negative donors | – | Other: Standard organ transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Solid organ transplant recipients
Key inclusion criteria (1 listed)
- Adult (>18 years old) male and female solid organ transplant recipients
Key exclusion criteria (2 listed)
- Absence of informed consent for the clinical protocol and the registry.
- Prisoners will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard organ transplantStandard organ transplant procedures and follow up care | Other | COVID-19 negative donors, COVID-19 positive donors |
Primary outcome
Number of participants who test positive for COVID-19
Time frame: 1 week post transplant
Serum COVID-19 T-cell specific immune response
Time frame: 4 week post transplant
Blood samples from participants will be tested for the presence or absence of COVID-19 immune response markers, i.e. T-cells. The existence of T-cells will be marked as positive, indicating an immune response in the participant to COVID-19.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Ambreen Azhar, MD principal investigator
Virginia Commonwealth University
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 Organ Transplant, run by Virginia Commonwealth University 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 1 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: finished, as of the sponsor's last update on 19 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants who test positive for COVID-19 (time frame: 1 week post transplant). The study lists 2 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 19 Aug 2025.