Immune Registry for Organ Transplantation From COVID Positive Donors.

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Organ Transplant
• Intervention / Treatment: Other: Standard organ transplant

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Solid organ transplant recipients

Description

Inclusion Criteria:

- Adult (>18 years old) male and female solid organ transplant recipients

Exclusion Criteria:

• Absence of informed consent for the clinical protocol and the registry.
• Prisoners will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 positive donors	Other: Standard organ transplant; Standard organ transplant procedures and follow up care
COVID-19 negative donors	Other: Standard organ transplant; Standard organ transplant procedures and follow up care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who test positive for COVID-19		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.	4 week post transplant

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Eurofins
• Investigators: Principal Investigator: Ambreen Azhar, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Actual): July 20, 2025
• Study Completion (Actual): July 20, 2025

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HM20024454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No