COVID-19 and Nonalcoholic Fatty Liver Disease

NCT04982328 | Completed DMC

• 1 other identifier: UHID07
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; NAFLD

Outcome Measures

Primary Outcomes (1)

• Th17 cytokines concentrations

  Measurement of Th17 cytokines concentration in serum of patients by multiplex technology

  Day of hospital admission

Secondary Outcomes (8)

• Staging of liver steatosis

  Day of hospital discharge (expected maximum of 28 days)

• Duration of hospitalization

  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)

Study Arms (2)

NAFLD

patients diagnosed with NAFLD and hospitalized due to the severe COVID-19

Diagnostic Test: Th17 cytokine profile; Diagnostic Test: Screening for the components of metabolic syndrome; Diagnostic Test: Evaluation of the degree of steatosis

non-NAFLD

patients hospitalized due to the with severe COVID-19 without NAFLD

Diagnostic Test: Th17 cytokine profile; Diagnostic Test: Screening for the components of metabolic syndrome; Diagnostic Test: Evaluation of the degree of steatosis

Interventions

Th17 cytokine profile DIAGNOSTIC_TEST

Screening for the components of metabolic syndrome

NAFLD; non-NAFLD

Screening for the components of metabolic syndrome DIAGNOSTIC_TEST

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.

NAFLD; non-NAFLD

Evaluation of the degree of steatosis DIAGNOSTIC_TEST

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.

NAFLD; non-NAFLD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

120 patients diagnosed with and hospitalized for severe COVID-19 (60 patients with NAFLD, 60 patients without NAFLD).

You may qualify if:

• Adult patients diagnosed with COVID-19

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital for Infectious Diseases, Croatia: lead

Study Sites (1)

University Hospital for Infectious Diseases Zagreb

Zagreb, 10000, Croatia

Location

Related 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.

  PMID: 36498623 RESULT

• 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.

  PMID: 35743825 RESULT

• 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.

  PMID: 37375073 RESULT

• 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 Feb 9;9(4):ofac073. doi: 10.1093/ofid/ofac073. eCollection 2022 Apr.

  PMID: 35287335 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples for cytokine analysis

MeSH Terms

Conditions

COVID-19; Non-alcoholic Fatty Liver Disease

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Neven Papic, MD, PhD

  School of Medicine, University of Zagreb, Croatia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: July 29, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 15, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)