Official Title
Th17 Immune Response in Patients With COVID-19 and Nonalcoholic Fatty Liver Disease
Brief Summary

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.

Detailed 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.

Unknown status
COVID19
NAFLD

Diagnostic Test: Th17 cytokine profile

Screening for the components of metabolic syndrome

Diagnostic Test: Screening for the components of metabolic syndrome

Anthropometric measures including height, weight, waist circumference and hip circumference will be measured in all patients. Results of the routine laboratory tests as part of the standard diagnostic procedure will be collected: CRP, leukocyte count, ratio neutrophils and lymphocytes, hemoglobin, platelet count, urea, creatinine, bilirubin, AST, ALT, GGT, ALP, albumins, fasting glucose.

Diagnostic Test: Evaluation of the degree of steatosis

The degree of steatosis will be estimated using the ultrasound and a method for grading steatosis will be measuring the degree of ultrasound attenuation by hepatic fat using a process based on simultaneous transient elastography (TE) which measures the degree of steatosis.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Croatia
Locations

University Hospital for Infectious Diseases Zagreb
Zagreb, Croatia

Investigator: Neven Papic, MD, PhD
Contact: +38512826222
npapic@bfm.hr

Investigator:

Contacts

Neven Papic, MD, PhD
003812826222
npapic@bfm.hr

Neven Papic, MD, PhD, Principal Investigator
School of Medicine, University of Zagreb, Croatia

University Hospital for Infectious Diseases, Croatia
NCT Number
MeSH Terms
COVID-19
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease