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Liver Injury in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04358380
Recruitment Status : Enrolling by invitation
First Posted : April 24, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Julia Cremona, Austral University, Argentina

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,


Condition or disease Intervention/treatment
Liver Injury Other: Liver injury

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

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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liver Injury in Hospitalized Patients With COVID-19 in Latin America: Clinical Characteristics and Prognostic Factors
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Prognostic factors associated with death [ Time Frame: through study completion, an average of 6 months ]
    Factors associated with worse outcome

  2. 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



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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients older than 17 years hospitalized with COVID-19
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04358380


Locations
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Argentina
Universidad Austral
Pilar, Buenos Aires, Argentina, 1629
Sponsors and Collaborators
Austral University, Argentina
Investigators
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Principal Investigator: Marcelo O Silva, MD Austral University
Publications:

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Responsible Party: Maria Julia Cremona, Coordinator, Austral University, Argentina
ClinicalTrials.gov Identifier: NCT04358380    
Other Study ID Numbers: CIE N° P 20-011
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Julia Cremona, Austral University, Argentina:
COVID-19
outcome
Additional relevant MeSH terms:
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Wounds and Injuries