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COVID-19 and Nonalcoholic Fatty Liver Disease (CovidFAT)

U

University Hospital for Infectious Diseases, Croatia

Status

Completed

Conditions

Covid19
NAFLD

Treatments

Diagnostic Test: Screening for the components of metabolic syndrome
Diagnostic Test: Th17 cytokine profile
Diagnostic Test: Evaluation of the degree of steatosis

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

COVID-19 is currently the leading public health problem, associated with a high risk of complications and death in risk groups of patients. Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease with a prevalence of 30% in the Western population and is also recognized as an independent risk factor for the development of severe COVID-19. In the pathogenesis of COVID-19, the key role is played by the hyperreactivity of the immune response, the so-called cytokine storm leading to the development of severe forms of pneumonia, acute respiratory and multiorgan failure. The aim of this study is to investigate the clinical course, outcomes, and profile of inflammatory response in patients with COVID-19 and NAFLD.

Full description

SARS-CoV-2 virus infection is currently the leading public health problem, associated with a high risk of complications and death in at-risk groups. Risk factors for the development of severe forms of COVID-19 include components of the metabolic syndrome (obesity, diabetes, dyslipidemia, and arterial hypertension), which are also associated with the development of nonalcoholic fatty liver disease (NAFLD). According to previously published, but mostly retrospective studies, NAFLD is a possible risk factor for the development of severe COVID-19. . In the pathogenesis of COVID-19, the key role is played by the hyperreactivity of the immune response, the so-called cytokine storm. According to recent research, activation of the Th17 system could play a key role in the regulation of this excessive inflammatory response. Furthermore, Th17 lymphocytes and cytokines are important in the development and progression of NAFLD. The question is whether, due to Th17 hyperreactivity, patients with NAFLD are at higher risk of developing severe forms of the disease and what is the profile of the Th17 immune response to SARS-CoV-2 infection in this group of patients.

Enrollment

120 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients diagnosed with COVID-19

Exclusion criteria

  • Immunosuppression
  • Consumption of alcohol > 20 g/day
  • HIV
  • Chronic viral hepatitis
  • Presence of other chronic liver disease (hemochromatosis, Wilson's disease, toxic hepatitis, deficiency of alpha-1-antitrypsin, liver autoimmune disease)
  • Pregnancy

Trial design

120 participants in 2 patient groups

NAFLD
Description:
patients diagnosed with NAFLD and hospitalized due to the severe COVID-19
Treatment:
Diagnostic Test: Evaluation of the degree of steatosis
Diagnostic Test: Th17 cytokine profile
Diagnostic Test: Screening for the components of metabolic syndrome
non-NAFLD
Description:
patients hospitalized due to the with severe COVID-19 without NAFLD
Treatment:
Diagnostic Test: Evaluation of the degree of steatosis
Diagnostic Test: Th17 cytokine profile
Diagnostic Test: Screening for the components of metabolic syndrome

Trial contacts and locations

1

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Central trial contact

Neven Papic, MD, PhD

Data sourced from clinicaltrials.gov

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