Clinical trial NCT04420637: Impact of the Covid-19 Pandemic on Gastrointestinal and Liver Diseases
Official title: Impact of the Covid-19 Pandemic on Gastrointestinal and Liver Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 1366
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with Covid-19 infection treated within the hospital group

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 Preliminary, unpublished data from China suggest that patients with GI symptoms may suffer more frequently from severe courses of the disease.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 Preliminary unpublished communications report conflicting data on COVID-19 in patients with chronic liver diseases.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

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

Primary outcomes:
measure: liver disease
timeFrame: through study completion, on average 30 days
Secondary outcomes:
measure: COVID infection in patients with chronic liver disease
timeFrame: during the pandemic, at longest until 31.12.2022
measure: decompensation of cirrhosis
timeFrame: during the pandemic, at longest until 31.12.2022
measure: Effect of Antiviral drugs on Covid-19 infection
timeFrame: during the pandemic, at longest until 31.12.2022
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Internal Medicine, Medical University of Graz
Study officials:
References: