COVID-19 and Nonalcoholic Fatty Liver Disease

Covid19 Clinical Trial

— CovidFAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04982328
• Other study ID #: UHID07
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: August 2023
• Source: University Hospital for Infectious Diseases, Croatia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 15, 2022
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Diagnostic Test:
• Th17 cytokine profile
Screening for the components of metabolic syndrome
• Screening 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.
• Evaluation 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.

Locations

Country	Name	City	State
Croatia	University Hospital for Infectious Diseases Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital for Infectious Diseases, Croatia

Country where clinical trial is conducted

Croatia, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Th17 cytokines concentrations	Measurement of Th17 cytokines concentration in serum of patients by multiplex technology	Day of hospital admission
Secondary	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)
Secondary	Duration of hospitalization	Days of hospitalization	Day of hospital discharge (expected maximum of 28 days)
Secondary	Remission of respiratory symptoms	Time to independence from oxygen therapy in days	Day of hospital discharge (expected maximum of 28 days)
Secondary	28 days survival	Number of subjects surviving at 28 days from hospitalization	Day of hospital discharge (expected maximum of 28 days)
Secondary	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	Secondary infections	Presence/absence of secondary infection during hospitalization	Day of hospital discharge (expected maximum of 28 days)
Secondary	Rate of invasive mechanical ventilation	Requirement of invasive mechanical ventilation	Day of hospital discharge (expected maximum of 28 days)
Secondary	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)