Secondary Sclerosing CholangitisNCT05233553
SSC-COVID in Patients After COVID-19
An observational study of Secondary Sclerosing Cholangitis and COVID-19, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Analysis of occurrence of SSC-COVID in SARS-CoV-2-patients after the first wave of COVID-pandemic Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Sclerosing Cholangitis, COVID-19
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2020to 31 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a study of adult patients who participated in the COVID-19 outpatient clinic at the University Hospital of Tübingen as part of the follow-up examinations after COVID-19 disease. In particular, the development of liver enzymes was analysed.
Who may be able to join
- post-COVID19-patients with required hospitalization during the first wave of COVID-19-pandemic
- patients controlled at the university ambulance for follow-up
Who cannot join
- children and patients younger than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Incidence of Secondary Sclerosing Cholangitis in Hospitalized "First-wave" COVID-19 Patients: a Retrospective Single Center Study
Analysis of occurrence of SSC-COVID in SARS-CoV-2-patients after the first wave of COVID-pandemic
Read the detailed description
In Central Europe, the first wave of SARS-CoV-2 peaked in April 2020 and ended in June 2020. Our tertiary care center, the University Hospital of Tübingen is located in a first-wave SARS-CoV-2 hotspot area that had the second highest 7-day incidence in Germany on March 31, 2020, exactly at the peak of the first wave in Germany (205.9/100,000, www.rki.de; the peak daily incidence in Tübingen was 179/100,000 on March 25, 2020). In this period, 249 patients were hospitalized for or with SARS-CoV-2 infection.
To gain fast knowledge about the new disease, a COVID-19 patient registry was established at our center, including all patients admitted to Tübingen University Hospital for or with SARS-CoV-2 infection and retrospectively collecting routine clinical data. After hospitalization, patients were followed up in the outpatient clinic of our department, the Department of Gastroenterology, Hepatology, Gastrointestinal Oncology, Geriatrics and Infectious Diseases.
Subsequently, several patients with secondary sclerosing cholangitis (SSC) after COVID-19 (SSC-COVID) were recognized in our center, either from our own cohort, or referred to our center due to the need for further treatment of end-stage liver disease including liver transplantation. SSC is a cholangiopathy estimated to be rare in ICU patients with an incidence of 1/2000 ICU patients. Pathogenesis has not been fully deciphered, but a combination of ischemic injury and increased bile toxicity during critical illness is suspected. This imposes acute damage on the biliary system, that, if not resolving early or spontaneously, may lead to the vicious circle of gradually destruction of the biliary tree over time, well known to hepatologists and endoscopists.
- Conditions
- Secondary Sclerosing Cholangitis, COVID-19
- Being tested
- control of liver enzymes
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control of liver enzymesOther
follow-up with clinical and laboratory measurements
| Study group | Role | What they receive |
|---|---|---|
| post-COVID-patients | Not described Receives: Other: control of liver enzymes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SSC-COVID in hospitalized COVID-patients of the first wave
While Follow-up-session controlled clinical and laboratory parameters
Measured: one and a half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Mar 2020
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Sclerosing CholangitisStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233553
- Sponsor's protocol ID
- 431/2020BO
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD are anonymised, the consent has been obtained from the ZKS.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Incidence of Secondary Sclerosing Cholangitis in Hospitalized "First-wave" COVID-19 Patients: a Retrospective Single Center Study
- ClinicalTrials.gov ID
- NCT05233553
- Acronym / sponsor ID
- 431/2020BO
- Conditions
- Secondary Sclerosing Cholangitis, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 10 Feb 2022 (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.
Analysis of occurrence of SSC-COVID in SARS-CoV-2-patients after the first wave of COVID-pandemic
Detailed description
In Central Europe, the first wave of SARS-CoV-2 peaked in April 2020 and ended in June 2020. Our tertiary care center, the University Hospital of Tübingen is located in a first-wave SARS-CoV-2 hotspot area that had the second highest 7-day incidence in Germany on March 31, 2020, exactly at the peak of the first wave in Germany (205.9/100,000, www.rki.de; the peak daily incidence in Tübingen was 179/100,000 on March 25, 2020). In this period, 249 patients were hospitalized for or with SARS-CoV-2 infection.
To gain fast knowledge about the new disease, a COVID-19 patient registry was established at our center, including all patients admitted to Tübingen University Hospital for or with SARS-CoV-2 infection and retrospectively collecting routine clinical data. After hospitalization, patients were followed up in the outpatient clinic of our department, the Department of Gastroenterology, Hepatology, Gastrointestinal Oncology, Geriatrics and Infectious Diseases.
Subsequently, several patients with secondary sclerosing cholangitis (SSC) after COVID-19 (SSC-COVID) were recognized in our center, either from our own cohort, or referred to our center due to the need for further treatment of end-stage liver disease including liver transplantation. SSC is a cholangiopathy estimated to be rare in ICU patients with an incidence of 1/2000 ICU patients. Pathogenesis has not been fully deciphered, but a combination of ischemic injury and increased bile toxicity during critical illness is suspected. This imposes acute damage on the biliary system, that, if not resolving early or spontaneously, may lead to the vicious circle of gradually destruction of the biliary tree over time, well known to hepatologists and endoscopists.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post-COVID-patients | – | Other: control of liver enzymes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a study of adult patients who participated in the COVID-19 outpatient clinic at the University Hospital of Tübingen as part of the follow-up examinations after COVID-19 disease. In particular, the development of liver enzymes was analysed.
Key inclusion criteria (2 listed)
- post-COVID19-patients with required hospitalization during the first wave of COVID-19-pandemic
- patients controlled at the university ambulance for follow-up
Key exclusion criteria (1 listed)
- children and patients younger than 18 years
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 |
|---|---|---|
| control of liver enzymesfollow-up with clinical and laboratory measurements | Other | post-COVID-patients |
Primary outcome
Incidence of SSC-COVID in hospitalized COVID-patients of the first wave
Time frame: one and a half year
While Follow-up-session controlled clinical and laboratory parameters
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 10 Feb 2022.
- Individual participant dataSharing planned: Undecided. IPD are anonymised, the consent has been obtained from the ZKS.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Secondary Sclerosing Cholangitis and COVID-19, run by University Hospital Tuebingen at 1 site in Germany.
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 2 inclusion and 1 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 10 Feb 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 Germany. 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 SSC-COVID in hospitalized COVID-patients of the first wave (time frame: one and a half year). 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 10 Feb 2022.