COVID-19 in Liver Transplant Recipients (COVID19-SETH)

August 2, 2022 updated by: Jordi Colmenero, Hospital Clinic of Barcelona

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • SETH-affiliated Liver Transplant Programs in Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Liver Transplantation

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19
Liver Transplant recipients
Other: Observational only
Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of COVID19 in LT recipients
Time Frame: 12 months
12 months
Clinical characteristics of COVID19 in LT recipients
Time Frame: 12 months
12 months
Survival and Mechanical ventilation / respiratory support
Time Frame: 3 months
3 months
Observed treatments and immunosuppression management
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Sociedad Española de Trasplante Hepático

Investigators

  • Principal Investigator: Jordi Colmenero, Sociedad Española de Trasplante Hepático

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2020/0384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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