COVID-19 in Liver Transplant Recipients

Completed

• Conditions: COVID19; Liver Transplant; Complications; Respiratory Failure
• Interventions: Other: Observational only

• Registration Number: NCT04361591
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

Detailed 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 .

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Liver Transplant recipient
• Confirmed (PCR positive) SARS-Cov-2 infection
• Informed Consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19	Observational only	Liver Transplant recipients

Primary Outcome Measures

Name	Time	Method
Incidence of COVID19 in LT recipients	12 months
Observed treatments and immunosuppression management	12 months
Clinical characteristics of COVID19 in LT recipients	12 months
Survival and Mechanical ventilation / respiratory support	3 months

Trial Locations

Locations (1)

SETH-affiliated Liver Transplant Programs in Spain; 🇪🇸 Barcelona, Spain