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

NCT ID: NCT04420637

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1366 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2022-12-31

Brief 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. 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.

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 Preliminary, unpublished data from China suggest that patients with GI symptoms may suffer more frequently from severe courses of the disease.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 Preliminary unpublished communications report conflicting data on COVID-19 in patients with chronic liver diseases.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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Internal Medicine, Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

RetroCov

Identifier Type: -

Identifier Source: org_study_id