COVID-19 and Nonalcoholic Fatty Liver Disease

Study Overview
=================
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.

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

Conditions
-----------------
Covid19, NAFLD

Intervention / Treatment
-----------------
* Diagnostic Test: Th17 cytokine profile
* Diagnostic Test: Screening for the components of metabolic syndrome
* Diagnostic Test: Evaluation of the degree of steatosis


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NAFLD<br>patients diagnosed with NAFLD and hospitalized due to the severe COVID-19 | Diagnostic Test: Th17 cytokine profile<br>* Screening for the components of metabolic syndrome<br>Diagnostic Test: Screening for the components of metabolic syndrome<br>* 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.<br>Diagnostic Test: Evaluation of the degree of steatosis<br>* 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.<br>|
| non-NAFLD<br>patients hospitalized due to the with severe COVID-19 without NAFLD | Diagnostic Test: Th17 cytokine profile<br>* Screening for the components of metabolic syndrome<br>Diagnostic Test: Screening for the components of metabolic syndrome<br>* 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.<br>Diagnostic Test: Evaluation of the degree of steatosis<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Th17 cytokines concentrations | Measurement of Th17 cytokines concentration in serum of patients by multiplex technology | Day of hospital admission | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |