Th17 Immune Response in Patients With COVID-19 and Nonalcoholic Fatty Liver Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- University Hospital for Infectious Diseases, Croatia
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Th17 cytokines concentrations
- Status
- Completed
- Last Updated
- 2 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients diagnosed with COVID-19
Exclusion Criteria
- •Immunosuppression
- •Consumption of alcohol \> 20 g/day
- •Chronic viral hepatitis
- •Presence of other chronic liver disease (hemochromatosis, Wilson's disease, toxic hepatitis, deficiency of alpha-1-antitrypsin, liver autoimmune disease)
- •Pregnancy
Outcomes
Primary Outcomes
Th17 cytokines concentrations
Time Frame: Day of hospital admission
Measurement of Th17 cytokines concentration in serum of patients by multiplex technology
Secondary Outcomes
- Staging of liver steatosis(Day of hospital discharge (expected maximum of 28 days))
- Rate of invasive mechanical ventilation(Day of hospital discharge (expected maximum of 28 days))
- Remission of respiratory symptoms(Day of hospital discharge (expected maximum of 28 days))
- 28 days survival(Day of hospital discharge (expected maximum of 28 days))
- Rate of high flow oxygen therapy or non-invasive ventilation(Day of hospital discharge (expected maximum of 28 days))
- Rate of pulmonary thromboembolism(Day of hospital discharge (expected maximum of 28 days))
- Duration of hospitalization(Day of hospital discharge (expected maximum of 28 days))
- Secondary infections(Day of hospital discharge (expected maximum of 28 days))