Liver Transplant; ComplicationsCOVID19-SETHNCT04361591
COVID-19 in Liver Transplant Recipients
An observational study of Liver Transplant; Complications and COVID19, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Prospective observational study aimed at analyzing the incidence, clinical characteristics and outcomes of COVID-19 in LT in Spain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Transplant; Complications, COVID19, Respiratory Failure
- What is being tested?
- Observational only
- How many people
- 121 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2020to 1 Mar 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Liver Transplantation
Who may be able to join
- Liver Transplant recipient
- Confirmed (PCR positive) SARS-Cov-2 infection
- Informed Consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 .
- Being tested
- Observational only
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational onlyOther
Observational Study
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Liver Transplant recipients Receives: Other: Observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of COVID19 in LT recipients
Measured: 12 months
Clinical characteristics of COVID19 in LT recipients
Measured: 12 months
Survival and Mechanical ventilation / respiratory support
Measured: 3 months
Observed treatments and immunosuppression management
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Mar 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Trasplante Hepático
- Responsible party
- Principal investigator, Jordi Colmenero, Hospital Clinic of Barcelona
- Investigators
- Jordi Colmenero, Principal investigator, Sociedad Española de Trasplante Hepático
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361591
- Sponsor's protocol ID
- HCB/2020/0384
- Acronym
- COVID19-SETH
- Status last verified
- Aug 2022
- First submitted
- 22 Apr 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 in Liver Transplant Recipients in Spain: a Nationwide Prospective Study
- ClinicalTrials.gov ID
- NCT04361591
- Acronym / sponsor ID
- COVID19-SETH / HCB/2020/0384
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Sociedad Española de Trasplante Hepático
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Other: Observational onlyLiver Transplant recipients |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Liver Transplantation
Key inclusion criteria (3 listed)
- Liver Transplant recipient
- Confirmed (PCR positive) SARS-Cov-2 infection
- Informed Consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational onlyObservational Study | Other | COVID-19 |
Primary outcome
Incidence of COVID19 in LT recipients
Time frame: 12 months
Clinical characteristics of COVID19 in LT recipients
Time frame: 12 months
Survival and Mechanical ventilation / respiratory support
Time frame: 3 months
Observed treatments and immunosuppression management
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- SETH webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordi Colmenero principal investigator
Sociedad Española de Trasplante Hepático
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications and COVID19, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of COVID19 in LT recipients (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.