Covid19, NAFLD
Conditions
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.
Interventions
DIAGNOSTIC_TESTTh17 cytokine profile
Screening for the components of metabolic syndrome
DIAGNOSTIC_TESTScreening 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_TESTEvaluation 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.
Sponsors
University Hospital for Infectious Diseases, Croatia
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Th17 cytokines concentrations | Day of hospital admission | Measurement of Th17 cytokines concentration in serum of patients by multiplex technology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospitalization | Day of hospital discharge (expected maximum of 28 days) | Days of hospitalization |
| Remission of respiratory symptoms | Day of hospital discharge (expected maximum of 28 days) | Time to independence from oxygen therapy in days |
| 28 days survival | Day of hospital discharge (expected maximum of 28 days) | Number of subjects surviving at 28 days from hospitalization |
| Staging of liver steatosis | Day of hospital discharge (expected maximum of 28 days) | The degree of steatosis will be estimated using the controlled attenuation parameter (CAP) in patients with NAFLD. |
| Secondary infections | Day of hospital discharge (expected maximum of 28 days) | Presence/absence of secondary infection during hospitalization |
| Rate of invasive mechanical ventilation | Day of hospital discharge (expected maximum of 28 days) | Requirement of invasive mechanical ventilation |
| Rate of pulmonary thromboembolism | Day of hospital discharge (expected maximum of 28 days) | Presence of pulmonary thromboembolism diagnosed with MSCT pulmonary angiography on clinical suspicion |
| Rate of high flow oxygen therapy or non-invasive ventilation | Day of hospital discharge (expected maximum of 28 days) | Requirement for high flow oxygen therapy during the initial hospitalisation |
Countries
Croatia
Outcome results
None listed