NCT04361591

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

April 22, 2020

Last Update Submit

August 2, 2022

Conditions

Liver Transplant; ComplicationsCOVID19Respiratory Failure

Outcome Measures

Primary Outcomes (4)

  • Incidence of COVID19 in LT recipients

    12 months

  • Clinical characteristics of COVID19 in LT recipients

    12 months

  • Survival and Mechanical ventilation / respiratory support

    3 months

  • Observed treatments and immunosuppression management

    12 months

Study Arms (1)

COVID-19

Liver Transplant recipients

Other: Observational only

Interventions

Observational onlyOTHER

Observational Study

COVID-19

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Liver Transplantation

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SETH-affiliated Liver Transplant Programs in Spain

Barcelona, Spain

Location

Related Links

MeSH Terms

Conditions

COVID-19Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Jordi Colmenero

    Sociedad Española de Trasplante Hepático

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Liver Transplant Hepatologist, SETH Scientific Committee Chair

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 24, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations

ES(1)