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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAFLD | patients diagnosed with NAFLD and hospitalized due to the severe COVID-19 |
| |
| non-NAFLD | patients hospitalized due to the with severe COVID-19 without NAFLD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Th17 cytokine profile | Diagnostic Test | Screening for the components of metabolic syndrome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Th17 cytokines concentrations | Measurement of Th17 cytokines concentration in serum of patients by multiplex technology | Day of hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| Staging of liver steatosis | The degree of steatosis will be estimated using the controlled attenuation parameter (CAP) in patients with NAFLD. | Day of hospital discharge (expected maximum of 28 days) |
| Duration of hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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120 patients diagnosed with and hospitalized for severe COVID-19 (60 patients with NAFLD, 60 patients without NAFLD).
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| Name | Affiliation | Role |
|---|---|---|
| Neven Papic, MD, PhD | School of Medicine, University of Zagreb, Croatia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital for Infectious Diseases Zagreb | Zagreb | 10000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36498623 | Result | 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. | |
| 35743825 | Result | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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serum samples for cytokine analysis
| Screening for the components of metabolic syndrome | Diagnostic Test | 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. |
|
| Evaluation of the degree of steatosis | Diagnostic Test | 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. |
|
Days of hospitalization
| Day of hospital discharge (expected maximum of 28 days) |
| Remission of respiratory symptoms | Time to independence from oxygen therapy in days | Day of hospital discharge (expected maximum of 28 days) |
| 28 days survival | Number of subjects surviving at 28 days from hospitalization | Day of hospital discharge (expected maximum of 28 days) |
| Rate of high flow oxygen therapy or non-invasive ventilation | Requirement for high flow oxygen therapy during the initial hospitalisation | Day of hospital discharge (expected maximum of 28 days) |
| Secondary infections | Presence/absence of secondary infection during hospitalization | Day of hospital discharge (expected maximum of 28 days) |
| Rate of invasive mechanical ventilation | Requirement of invasive mechanical ventilation | Day of hospital discharge (expected maximum of 28 days) |
| Rate of pulmonary thromboembolism | Presence of pulmonary thromboembolism diagnosed with MSCT pulmonary angiography on clinical suspicion | Day of hospital discharge (expected maximum of 28 days) |
| 37375073 | Result | 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. |
| 35287335 | Result | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |