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COVIDRetroCovNCT04420637

Impact of the Covid-19 Pandemic on Gastrointestinal and Liver Diseases

An observational study of COVID, run by Medical University of Graz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims primarily 1. to assess the frequency, nature and outcome of liver disease caused or associated with COVD-19 Furthermore, the study also aims 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
COVID
How many people
1,366 participants
Where
1 siteAustria
Study dates
15 Jun 2020to 31 Dec 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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)

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Department of Internal Medicine, Medical University of Graz

    Graz, 8010

Other trials in Austria

About this study

This study aims primarily

  1. to assess the frequency, nature and outcome of liver disease caused or associated with COVD-19 Furthermore, the study also aims
  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. to assess, whether quarantine measures impact on the rate of decompensation of liver cirrhosis
  4. to assess whether the intake of antiviral drugs protects against SARS-CoV-2 infection or COVID disease.
Read the detailed description

The outbreak of the novel coronavirus (SARS-CoV-2)-infected disease (COVID-19) began in Wuhan, Hubei province in December 2019, spread throughout China in early 2020 and developed as a pandemic thereafter. Although the virus mainly causes respiratory symptoms, GI presentations have been reported in and outside of China. Patients may present with anorexia, nausea, vomiting and abdominal discomfort. Also, faecal-oral transmission of the virus is currently discussed. Preliminary, unpublished data from China suggest that patients with GI symptoms may suffer more frequently from severe courses of the disease. Furthermore, liver injury has been observed during COVID-19 disease.

It is currently unclear, whether patients with chronic liver diseases are at a higher risk to contract COVID-19, to develop a more severe disease course or exhibit higher mortality. Preliminary unpublished communications report conflicting data on COVID-19 in patients with chronic liver diseases. According to those reports, it seems that immunosuppressed individuals (e.g. stable patients after liver transplantation or patients with autoimmune liver disease) do not suffer from more severe pulmonary disease when infected with SARS-CoV-2 compared to non-immunosuppressed individuals. To understand the impact of Covid-19 disease on patients with liver diseases, two registries have been launched to collect anonymous data (SECURE-cirrhosis and COVID-Hep.net). As by 1st of April 24 cases with 4 fatalities have been reported, however, this system does not provide enough information to understand the risk of patients in more detail, since it is unknown if all patients are reported and how many patients were at risk. Furthermore, the available data are very superficial.

Besides the direct effects of COVID-19, patients with chronic liver diseases might also be vulnerable to the indirect effects of the pandemic. Quarantine measures may have considerable psychological impact and may cause post-traumatic stress symptoms, confusion, and anger. There is no available data on the impact of quarantine on risk behaviour, such as alcohol consumption or the use of other liver toxic substances. Such behaviour - although destructive for everyone - can increase the risk of decompensation in patients with liver cirrhosis and cause potentially lethal complications which might require intensive care. Furthermore, the difficulty of access to care for patients with chronic diseases may impact negatively on the course of chronic diseases. To date, it is unclear whether the restricted social life and the restrictions in access to care during the pandemic impacts on liver-related morbidity and mortality.

Another possibility of how studying patients with liver diseases can benefit the general population, is to analyse their medications. Patients with chronic liver disease receive a specialised set of drugs, some of which might be effective against SARS-CoV-2. Unfortunately, the first emergency trial using ritonavir/Lopinavir - antiviral substances that are used to treat HIV and HIV/Hepatitis B or C coinfections - showed disappointing results against SARS-CoV-2. However, other antiviral drugs, for example against hepatitis C, could theoretically also be beneficial. It is currently unknown if patients who take drugs against viral hepatitis may be protected against COVID-19 and a retrospective risk assessment might contribute to more informed studies and a more rational distribution of resources.

Conditions
COVID

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. liver disease

    elevated transaminases

    Measured: through study completion, on average 30 days

Secondary outcomes (3)
  1. COVID infection in patients with chronic liver disease

    frequency of COVID infection in patients with known chronic liver disease

    Measured: during the pandemic, at longest until 31.12.2022

  2. decompensation of cirrhosis

    episodes of decompensation of cirrhosis in relation to quarantine measures

    Measured: during the pandemic, at longest until 31.12.2022

  3. Effect of Antiviral drugs on Covid-19 infection

    frequency of infections in people taking antiviral drugs against hepatitis B or C

    Measured: during the pandemic, at longest until 31.12.2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start15 Jun 2020
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

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
1,366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04420637
Sponsor's protocol ID
RetroCov
Acronym
RetroCov
Status last verified
Jan 2023
First submitted
4 Jun 2020
Last updated
12 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of COVID, run by Medical University of Graz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2023. 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 Austria. 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?

liver disease (time frame: through study completion, on average 30 days). 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 12 Jan 2023.

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