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NCT04361591 Clinical Trial

COVID-19 in Liver Transplant Recipients

COVID19 Clinical Trial

— COVID19-SETH  

Official title:
COVID-19 in Liver Transplant Recipients in Spain: a Nationwide Prospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04361591
Other study ID # HCB/2020/0384
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date March 1, 2021

Study information
Verified date August 2022
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Prospective observational study aimed at analyzing the incidence, clinical characteristics and outcomes of COVID-19 in LT in Spain.

Description:

Coronavirus Disease 2019 (COVID-19) is a novel viral disease caused by the SARS-Cov-2 infection with a particular predominance of upper and lower respiratory tract symptoms. First diagnosed in China in late 2019, the virus has progressed to a state of pandemia, involving Spain with a important outbreak. While the outcomes of viral infections in solid organ transplant (SOT) recipients tend to be worse than those from the general population due to chronic immunosuppression, there is little information on the incidence and outcomes of COVID-19 in liver transplant (LT) recipients. LT recipients are usually under less immunosuppression than other SOT and the clinical expression and outcomes of COVID-19 may be different to the reported outcomes in other SOT. The Spanish Society of Liver Transplantation, which includes 25 LT programs, has promoted a nationwide registry for LT with COVID-19 to help ascertain the incidence and outcomes and help evidence-based management .

Recruitment information / eligibility
Status Completed
Enrollment 121
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Liver Transplant recipient - Confirmed (PCR positive) SARS-Cov-2 infection - Informed Consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observational only
Observational Study

Locations
Country Name City State
Spain SETH-affiliated Liver Transplant Programs in Spain Barcelona

Sponsors (2)
Lead Sponsor Collaborator
Hospital Clinic of Barcelona Sociedad Española de Trasplante Hepático

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of COVID19 in LT recipients 12 months
Primary Clinical characteristics of COVID19 in LT recipients 12 months
Primary Survival and Mechanical ventilation / respiratory support 3 months
Primary Observed treatments and immunosuppression management 12 months
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