Liver Injury in Patients With COVID-19

July 19, 2020 updated by: Maria Julia Cremona, Austral University, Argentina

Liver Injury in Hospitalized Patients With COVID-19 in Latin America: Clinical Characteristics and Prognostic Factors

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,

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, 1629
        • Universidad Austral

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients older than 17 years hospitalized with COVID-19

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients without Liver Injury
Hospitalized patients with COVID-19 disease who did not develop liver injury
Patients with Liver Injury
Hospitalized patients with COVID-19 disease who develop liver injury
Other: Liver injury
LFTs elevation or liver decompensation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver injury in patients with COVID-19
Time Frame: through study completion, an average of 6 months
Hospitalized patients with COVD-19 who developed liver injury
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic factors associated with death
Time Frame: through study completion, an average of 6 months
Factors associated with worse outcome
through study completion, an average of 6 months
Clinical characteristics of patients who developed liver injury
Time Frame: through study completion, an average of 6 months
Description of patients hospitalized with COVID-19
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austral University, Argentina

Investigators

  • Principal Investigator: Marcelo O Silva, MD, Austral University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

April 18, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 19, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIE N° P 20-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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