COVID-19 and Nonalcoholic Fatty Liver Disease

Completed

• Conditions: NAFLD; Covid19
• Interventions: Diagnostic Test: Th17 cytokine profile; Diagnostic Test: Screening for the components of metabolic syndrome; Diagnostic Test: Evaluation of the degree of steatosis

• Registration Number: NCT04982328
• Lead Sponsor: University Hospital for Infectious Diseases, Croatia

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.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-07-24
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-07-29
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-27
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NAFLD	Evaluation of the degree of steatosis	patients diagnosed with NAFLD and hospitalized due to the severe COVID-19
non-NAFLD	Th17 cytokine profile	patients hospitalized due to the with severe COVID-19 without NAFLD
NAFLD	Th17 cytokine profile	patients diagnosed with NAFLD and hospitalized due to the severe COVID-19
non-NAFLD	Screening for the components of metabolic syndrome	patients hospitalized due to the with severe COVID-19 without NAFLD
non-NAFLD	Evaluation of the degree of steatosis	patients hospitalized due to the with severe COVID-19 without NAFLD
NAFLD	Screening for the components of metabolic syndrome	patients diagnosed with NAFLD and hospitalized due to the severe COVID-19

Primary Outcome Measures

Name	Time	Method
Th17 cytokines concentrations	Day of hospital admission	Measurement of Th17 cytokines concentration in serum of patients by multiplex technology

Secondary Outcome Measures

Name	Time	Method
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.
Rate of invasive mechanical ventilation	Day of hospital discharge (expected maximum of 28 days)	Requirement of invasive mechanical ventilation
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
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
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
Duration of hospitalization	Day of hospital discharge (expected maximum of 28 days)	Days of hospitalization
Secondary infections	Day of hospital discharge (expected maximum of 28 days)	Presence/absence of secondary infection during hospitalization

Trial Locations

Locations (1)

University Hospital for Infectious Diseases Zagreb; 🇭🇷 Zagreb, Croatia