COVID19-SETH: COVID-19 in Liver Transplant Recipients

• Sponsor: Hospital Clinic of Barcelona (Other)
• Overall Status: Completed
• CT.gov ID: NCT04361591
• Collaborator: Sociedad Española de Trasplante Hepático (Other)
• Enrollment: 121
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant; Complications; COVID19; Respiratory Failure	Other: Observational only

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 121 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: COVID-19 in Liver Transplant Recipients in Spain: a Nationwide Prospective Study
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 Liver Transplant recipients	Other: Observational only; Observational Study

Outcome Measures

Primary Outcome Measures

1. Incidence of COVID19 in LT recipients [12 months]

2. Clinical characteristics of COVID19 in LT recipients [12 months]

3. Survival and Mechanical ventilation / respiratory support [3 months]

4. Observed treatments and immunosuppression management [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Liver Transplant recipient

• Confirmed (PCR positive) SARS-Cov-2 infection

• Informed Consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SETH-affiliated Liver Transplant Programs in Spain	Barcelona		Spain

Sponsors and Collaborators

• Hospital Clinic of Barcelona
• Sociedad Española de Trasplante Hepático

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• SETH webpage

Publications

None provided.

• Responsible Party: Jordi Colmenero, Liver Transplant Hepatologist, SETH Scientific Committee Chair, Hospital Clinic of Barcelona
• ClinicalTrials.gov Identifier: NCT04361591
• Other Study ID Numbers: HCB/2020/0384
• First Posted: Apr 24, 2020
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Respiratory Insufficiency

Study Results

No Results Posted as of Aug 3, 2022