Covid19CovidFATNCT04982328
COVID-19 and Nonalcoholic Fatty Liver Disease
An observational study of Covid19 and NAFLD, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Th17 cytokine profile, Screening for the components of metabolic syndrome and Evaluation of the degree of steatosis
- How many people
- 120 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2021to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: 120 patients diagnosed with and hospitalized for severe COVID-19 (60 patients with NAFLD, 60 patients without NAFLD).
Who may be able to join
- Adult patients diagnosed with COVID-19
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University Hospital for Infectious Diseases Zagreb
Zagreb, 10000
About this study
Official title: Th17 Immune Response in Patients With 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.
Read the 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.
- Being tested
- Th17 cytokine profile, Screening for the components of metabolic syndrome, Evaluation of the degree of steatosis
- Medical subject headings
- COVID-19, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Th17 cytokine profileDiagnostic test
Screening for the components of metabolic syndrome
Screening for the components of metabolic syndromeDiagnostic 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 steatosisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| NAFLD | patients diagnosed with NAFLD and hospitalized due to the severe COVID-19 Receives: 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 Receives: Diagnostic Test: Th17 cytokine profile; Diagnostic Test: Screening for the components of metabolic syndrome; Diagnostic Test: Evaluation of the degree of steatosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Th17 cytokines concentrations
Measurement of Th17 cytokines concentration in serum of patients by multiplex technology
Measured: Day of hospital admission
Secondary outcomes (8)
Staging of liver steatosis
The degree of steatosis will be estimated using the controlled attenuation parameter (CAP) in patients with NAFLD.
Measured: Day of hospital discharge (expected maximum of 28 days)
Duration of hospitalization
Days of hospitalization
Measured: Day of hospital discharge (expected maximum of 28 days)
Remission of respiratory symptoms
Time to independence from oxygen therapy in days
Measured: Day of hospital discharge (expected maximum of 28 days)
28 days survival
Number of subjects surviving at 28 days from hospitalization
Measured: Day of hospital discharge (expected maximum of 28 days)
Rate of high flow oxygen therapy or non-invasive ventilation
Requirement for high flow oxygen therapy during the initial hospitalisation
Measured: Day of hospital discharge (expected maximum of 28 days)
Secondary infections
Presence/absence of secondary infection during hospitalization
Measured: Day of hospital discharge (expected maximum of 28 days)
Rate of invasive mechanical ventilation
Requirement of invasive mechanical ventilation
Measured: Day of hospital discharge (expected maximum of 28 days)
Rate of pulmonary thromboembolism
Presence of pulmonary thromboembolism diagnosed with MSCT pulmonary angiography on clinical suspicion
Measured: Day of hospital discharge (expected maximum of 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2021
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital for Infectious Diseases, Croatia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neven Papic, MD, PhD, Principal investigator, School of Medicine, University of Zagreb, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982328
- Sponsor's protocol ID
- UHID07
- Acronym
- CovidFAT
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36498623Papic 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.
PubMed 35743825Susak 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.
PubMed 37375073Vrsaljko 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.
PubMed 35287335
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Th17 Immune Response in Patients With COVID-19 and Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04982328
- Acronym / sponsor ID
- CovidFAT / UHID07
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital for Infectious Diseases, CroatiaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFLD | – | Diagnostic Test: Th17 cytokine profile, Diagnostic Test: Screening for the components of metabolic syndrome, Diagnostic Test: Evaluation of the degree of steatosispatients diagnosed with NAFLD and hospitalized due to the severe COVID-19 |
| non-NAFLD | – | Diagnostic Test: Th17 cytokine profile, Diagnostic Test: Screening for the components of metabolic syndrome, Diagnostic Test: Evaluation of the degree of steatosispatients hospitalized due to the with severe COVID-19 without NAFLD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 120 patients diagnosed with and hospitalized for severe COVID-19 (60 patients with NAFLD, 60 patients without NAFLD).
Key inclusion criteria (1 listed)
- Adult patients diagnosed with COVID-19
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Th17 cytokine profileScreening for the components of metabolic syndrome | Diagnostic test | NAFLD, non-NAFLD |
| Screening for the components of metabolic syndromeAnthropometric 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 test | NAFLD, non-NAFLD |
| Evaluation of the degree of steatosisThe 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. | Diagnostic test | NAFLD, non-NAFLD |
Primary outcome
Th17 cytokines concentrations
Time frame: Day of hospital admission
Measurement of Th17 cytokines concentration in serum of patients by multiplex technology
8 secondary outcomes
Staging of liver steatosis
Time frame: Day of hospital discharge (expected maximum of 28 days)
Duration of hospitalization
Time frame: Day of hospital discharge (expected maximum of 28 days)
Remission of respiratory symptoms
Time frame: Day of hospital discharge (expected maximum of 28 days)
28 days survival
Time frame: Day of hospital discharge (expected maximum of 28 days)
Rate of high flow oxygen therapy or non-invasive ventilation
Time frame: Day of hospital discharge (expected maximum of 28 days)
Secondary infections
Time frame: Day of hospital discharge (expected maximum of 28 days)
Rate of invasive mechanical ventilation
Time frame: Day of hospital discharge (expected maximum of 28 days)
Rate of pulmonary thromboembolism
Time frame: Day of hospital discharge (expected maximum of 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Results publication: PubMed 36498623Mocibob 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.
- Results publication: PubMed 35743825Papic 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.
- Results publication: PubMed 37375073Susak 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.
- Results publication: PubMed 35287335Vrsaljko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neven Papic, MD, PhD principal investigator
School of Medicine, University of Zagreb, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and NAFLD, run by University Hospital for Infectious Diseases, Croatia at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Th17 cytokines concentrations (time frame: Day of hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04982328, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.