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| Name | Class |
|---|---|
| Eurofins | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 positive donors |
| ||
| COVID-19 negative donors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard organ transplant | Other | Standard organ transplant procedures and follow up care |
|
| 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 |
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Inclusion Criteria:
- Adult (>18 years old) male and female solid organ transplant recipients
Exclusion Criteria:
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Solid organ transplant recipients
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| Name | Affiliation | Role |
|---|---|---|
| Ambreen Azhar, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |