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Completed

NCT Number: NCT04361591

COVID-19 in Liver Transplant Recipients

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

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Key information

Conditions

Liver Transplant; Complications COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

SETH-affiliated Liver Transplant Programs in Spain

Barcelona, Spain

About this study

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 .

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Observational only

Other

Observational Study

Primary outcomes

  1. Incidence of COVID19 in LT recipients

    Time frame: 12 months

  2. Clinical characteristics of COVID19 in LT recipients

    Time frame: 12 months

  3. Survival and Mechanical ventilation / respiratory support

    Time frame: 3 months

  4. Observed treatments and immunosuppression management

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Sociedad Española de Trasplante Hepático

Registry information

Official study title

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

Acronym: COVID19-SETH

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2020
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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