Clinical trial NCT04358380: Liver Injury in Patients With COVID-19
Official title: Liver Injury in Hospitalized Patients With COVID-19 in Latin America: Clinical Characteristics and Prognostic Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Injury
Keywords: COVID-19
outcome
Lead sponsor: Austral University, Argentina
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 320
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 17 years hospitalized with COVID-19

Brief summary: Coronavirus disease was first diagnosed in December 2019, in the city of Wuhan, China. The World Health Organization recently declared coronavirus disease 2019 (COVID-19) as a pandemic. The infection is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is a single-stranded RNA virus, which in humans causes mild respiratory symptoms and generally has a good prognosis. However, in a certain group of patients it manifests as severe pneumonia, respiratory distress syndrome, multiple organ dysfunction and death. The factors associated with a worse prognosis are older than 60 years, the presence of diabetes, cardiovascular disease and obesity. According to studies carried out in the Eastern world, the prevalence of liver injury in patients with COVID-19 disease varies between 14% and 53%, being more prevalent in patients with severe symptoms of COVID-19 disease.

It is not really known whether the liver involvement of patients with SARS-CoV-2 infection is secondary to the direct effect of the virus on the liver. One of the mechanisms of action of SARS-CoV-2 is through the binding to the angiotensin-converting enzyme receptor, which is present in cholangiocytes, this could explain its excretion in faeces. However, liver injury could be due to the immune response generated in the body by the virus with systemic inflammatory response syndrome and the release of inflammatory cytokines such as IL6, generating direct cytopathic damage to the liver. On the other hand, it could be the product of hepatotoxic drugs administered during hospitalization, such as antibiotics, antivirals or non-steroidal anti-inflammatory drugs. Liver biopsy described microvacuolar steatosis, and a mild portal and lobular inflammatory infiltrate .

Therefore, the aim this study is to assess the prevalence of liver complications (liver injury, decompensation of cirrhosis) in patients diagnosed with COVID-19 in Latin America. As secondary objectives, the investigators will describe the clinical characteristics of COVID-19 disease and identify risk factors associated with poor prognosis,

Detailed description: Scenario Multicenter study of patients hospitalized with SARS-CoV-2 in different institutions in Latin America and directed by the Coronavirus and Liver interest group of the Latin American Association for the Study of the Liver (ALEH), coordinated by Dr. Marcelo Silva. This project has been presented to ALEH, which has considered it of high interest and will promote its dissemination among partners and related Associations with the aim of obtaining the greatest participation from the centers in the region.

Design Observational cross-sectional study to describe the prevalence of liver disease in patients hospitalized for SARS-CoV-2. The administrative period of the study will be from 04/25/20 to 12/15/20. The enrollment date of the patients will be the date of the diagnosis of SARS-CoV-2 infection and the date of end of follow-up will be the day of hospital discharge, referral to another center or death.

Participating centers will identify patients who meet the selection criteria during the study period. The diagnosis of SARS-CoV-2 can be made at any time during hospitalization. All included patients will be evaluated and treated according to the specific protocol of each institution. The follow-up period will run until the day of hospital discharge or death.

A specific coded form will be prepared for data registration, which will be subsequently downloaded to a computerized database for subsequent analysis. The exposure variables included in the form will be collected by the investigating doctors.

The following study will be performed following international recommendations for observational studies STROBE guidelines

Eligibility criteria: Inclusion Criteria:

* Patients older than 17 years
* Patients with diagnosis of SARS-CoV-2 infection
* Hospitalized patients

Exclusion Criteria:

-

Primary outcomes:
measure: Liver injury in patients with COVID-19
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Prognostic factors associated with death
timeFrame: through study completion, an average of 6 months
measure: Clinical characteristics of patients who developed liver injury
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Pilar
country: Argentina
facility: Universidad Austral
state: Buenos Aires
Study officials:
affiliation: Austral University
name: Marcelo O Silva, MD
role: PRINCIPAL_INVESTIGATOR
References:
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