Clinical trial NCT04982328: COVID-19 and Nonalcoholic Fatty Liver Disease
Official title: Th17 Immune Response in Patients With COVID-19 and Nonalcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
NAFLD
Lead sponsor: University Hospital for Infectious Diseases, Croatia
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 patients diagnosed with and hospitalized for severe COVID-19 (60 patients with NAFLD, 60 patients without NAFLD).

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.

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

Primary outcomes:
measure: Th17 cytokines concentrations
timeFrame: Day of hospital admission
Secondary outcomes:
measure: Staging of liver steatosis
timeFrame: Day of hospital discharge (expected maximum of 28 days)
measure: Duration of hospitalization
timeFrame: Day of hospital discharge (expected maximum of 28 days)
measure: Remission of respiratory symptoms
timeFrame: Day of hospital discharge (expected maximum of 28 days)
measure: 28 days survival
timeFrame: Day of hospital discharge (expected maximum of 28 days)
measure: Rate of high flow oxygen therapy or non-invasive ventilation
timeFrame: Day of hospital discharge (expected maximum of 28 days)
measure: Secondary infections
timeFrame: Day of hospital discharge (expected maximum of 28 days)
measure: Rate of invasive mechanical ventilation
timeFrame: Day of hospital discharge (expected maximum of 28 days)
measure: Rate of pulmonary thromboembolism
timeFrame: Day of hospital discharge (expected maximum of 28 days)
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital for Infectious Diseases Zagreb
Study officials:
affiliation: School of Medicine, University of Zagreb, Croatia
name: Neven Papic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mocibob L, Susak F, Situm M, Viskovic K, Papic N, Vince A. COVID-19 and Pulmonary Thrombosis-An Unresolved Clinical Puzzle: A Single-Center Cohort Study. J Clin Med. 2022 Nov 29;11(23):7049. doi: 10.3390/jcm11237049.
citation: Papic N, Samadan L, Vrsaljko N, Radmanic L, Jelicic K, Simicic P, Svoboda P, Lepej SZ, Vince A. Distinct Cytokine Profiles in Severe COVID-19 and Non-Alcoholic Fatty Liver Disease. Life (Basel). 2022 May 26;12(6):795. doi: 10.3390/life12060795.
citation: Susak F, Vrsaljko N, Vince A, Papic N. TGF Beta as a Prognostic Biomarker of COVID-19 Severity in Patients with NAFLD-A Prospective Case-Control Study. Microorganisms. 2023 Jun 13;11(6):1571. doi: 10.3390/microorganisms11061571.
citation: Vrsaljko N, Samadan L, Viskovic K, Mehmedovic A, Budimir J, Vince A, Papic N. Association of Nonalcoholic Fatty Liver Disease With COVID-19 Severity and Pulmonary Thrombosis: CovidFAT, a Prospective, Observational Cohort Study. Open Forum Infect Dis. 2022 Feb 9;9(4):ofac073. doi: 10.1093/ofid/ofac073. eCollection 2022 Apr.