NCT05595837

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 29, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

October 20, 2022

Last Update Submit

August 13, 2025

Conditions

COVID-19Organ Transplant

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

COVID-19 positive donors

Other: Standard organ transplant

COVID-19 negative donors

Other: Standard organ transplant

Interventions

Standard organ transplantOTHER

Standard organ transplant procedures and follow up care

COVID-19 negative donorsCOVID-19 positive donors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Solid organ transplant recipients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ambreen Azhar, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 27, 2022

Study Start

December 29, 2022

Primary Completion

July 20, 2025

Study Completion

July 20, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)