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OpenTrials
Completed

NCT Number: NCT05233553

SSC-COVID in Patients After COVID-19

Analysis of occurrence of SSC-COVID in SARS-CoV-2-patients after the first wave of COVID-pandemic

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Tuebingen

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • post-COVID19-patients with required hospitalization during the first wave of COVID-19-pandemic
  • patients controlled at the university ambulance for follow-up

Exclusion criteria

  • children and patients younger than 18 years

Treatment and study plan

control of liver enzymes

Other

follow-up with clinical and laboratory measurements

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

High Incidence of Secondary Sclerosing Cholangitis in Hospitalized "First-wave" COVID-19 Patients: a Retrospective Single Center Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 10, 2022
Registry last updated
Feb 10, 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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