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NCT Number: NCT04982328

COVID-19 and Nonalcoholic Fatty Liver Disease

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Th17 cytokine profile

Diagnostic Test

Screening for the components of metabolic syndrome

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.

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.

Primary outcomes

  1. Th17 cytokines concentrations

    Time frame: Day of hospital admission

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

Secondary outcomes

  1. Staging of liver steatosis

    Time frame: 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.

  2. Duration of hospitalization

    Time frame: Day of hospital discharge (expected maximum of 28 days)

    Days of hospitalization

  3. Remission of respiratory symptoms

    Time frame: Day of hospital discharge (expected maximum of 28 days)

    Time to independence from oxygen therapy in days

  4. 28 days survival

    Time frame: Day of hospital discharge (expected maximum of 28 days)

    Number of subjects surviving at 28 days from hospitalization

  5. Rate of high flow oxygen therapy or non-invasive ventilation

    Time frame: Day of hospital discharge (expected maximum of 28 days)

    Requirement for high flow oxygen therapy during the initial hospitalisation

  6. Secondary infections

    Time frame: Day of hospital discharge (expected maximum of 28 days)

    Presence/absence of secondary infection during hospitalization

  7. Rate of invasive mechanical ventilation

    Time frame: Day of hospital discharge (expected maximum of 28 days)

    Requirement of invasive mechanical ventilation

  8. Rate of pulmonary thromboembolism

    Time frame: Day of hospital discharge (expected maximum of 28 days)

    Presence of pulmonary thromboembolism diagnosed with MSCT pulmonary angiography on clinical suspicion

Sponsors and collaborators

Lead sponsor

University Hospital for Infectious Diseases, Croatia

Other

Registry information

Official study title

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

Acronym: CovidFAT

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 29, 2021
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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