NCT04420637

Brief Summary

This study aims primarily

  1. 1.to assess the frequency, nature and outcome of liver disease caused or associated with COVD-19 Furthermore, the study also aims
  2. 2.to assess the impact of COVID-19 on patients with chronic liver disease or after liver transplantation (frequency of infections, course of disease, outcome)
  3. 3.to assess, whether quarantine measures impact on the rate of decompensation of liver cirrhosis
  4. 4.to assess whether the intake of antiviral drugs protects against SARS-CoV-2 infection or COVID disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,366

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

2.5 years

First QC Date

June 4, 2020

Last Update Submit

January 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • liver disease

    elevated transaminases

    through study completion, on average 30 days

Secondary Outcomes (3)

  • COVID infection in patients with chronic liver disease

    during the pandemic, at longest until 31.12.2022

  • decompensation of cirrhosis

    during the pandemic, at longest until 31.12.2022

  • Effect of Antiviral drugs on Covid-19 infection

    during the pandemic, at longest until 31.12.2022

Eligibility Criteria

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

all patients with Covid-19 infection treated within the hospital group

Covid-19 infection treated within the KAGES (Steirische Krankenanstalten GesmBH = Styrian public hospitals)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Medical University of Graz

Graz, 8010, Austria

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 9, 2020

Study Start

June 15, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations