Liver Injury in Patients With COVID-19

NCT04358380 | Unknown

• 1 other identifier: CIE N° P 20-011
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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,

Conditions

Liver Injury

Keywords

COVID-19; outcome

Outcome Measures

Primary Outcomes (1)

• Liver injury in patients with COVID-19

  Hospitalized patients with COVD-19 who developed liver injury

  through study completion, an average of 6 months

Secondary Outcomes (2)

• Prognostic factors associated with death

  through study completion, an average of 6 months

• Clinical characteristics of patients who developed liver injury

  through study completion, an average of 6 months

Study Arms (2)

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

Interventions

Liver injury OTHER

LFTs elevation or liver decompensation

Patients with Liver Injury

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 17 years hospitalized with COVID-19

You may qualify if:

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

Sponsors & Collaborators

• Austral University, Argentina: lead

Study Sites (1)

Universidad Austral

Pilar, Buenos Aires, 1629, Argentina

Location

Related Publications (9)

• Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

  PMID: 32109013 BACKGROUND

• Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 BACKGROUND

• MacLaren G, Fisher D, Brodie D. Preparing for the Most Critically Ill Patients With COVID-19: The Potential Role of Extracorporeal Membrane Oxygenation. JAMA. 2020 Apr 7;323(13):1245-1246. doi: 10.1001/jama.2020.2342. No abstract available.

  PMID: 32074258 BACKGROUND

• Fix OK, Hameed B, Fontana RJ, Kwok RM, McGuire BM, Mulligan DC, Pratt DS, Russo MW, Schilsky ML, Verna EC, Loomba R, Cohen DE, Bezerra JA, Reddy KR, Chung RT. Clinical Best Practice Advice for Hepatology and Liver Transplant Providers During the COVID-19 Pandemic: AASLD Expert Panel Consensus Statement. Hepatology. 2020 Jul;72(1):287-304. doi: 10.1002/hep.31281.

  PMID: 32298473 BACKGROUND

• Zhang C, Shi L, Wang FS. Liver injury in COVID-19: management and challenges. Lancet Gastroenterol Hepatol. 2020 May;5(5):428-430. doi: 10.1016/S2468-1253(20)30057-1. Epub 2020 Mar 4. No abstract available.

  PMID: 32145190 BACKGROUND

• Liu W, Tao ZW, Wang L, Yuan ML, Liu K, Zhou L, Wei S, Deng Y, Liu J, Liu HG, Yang M, Hu Y. Analysis of factors associated with disease outcomes in hospitalized patients with 2019 novel coronavirus disease. Chin Med J (Engl). 2020 May 5;133(9):1032-1038. doi: 10.1097/CM9.0000000000000775.

  PMID: 32118640 BACKGROUND

• Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.

  PMID: 32167524 BACKGROUND

• Mendizabal M, Ridruejo E, Pinero F, Anders M, Padilla M, Toro LG, Torre A, Montes P, Urzua A, Gonzalez Ballerga E, Silveyra MD, Michelato D, Diaz J, Peralta M, Pages J, Garcia SR, Gutierrez Lozano I, Macias Y, Cocozzella D, Chavez-Tapia N, Tagle M, Dominguez A, Varon A, Vera Pozo E, Higuera-de la Tijera F, Bustios C, Conte D, Escajadillo N, Gomez AJ, Tenorio L, Castillo Barradas M, Schinoni MI, Bessone F, Contreras F, Nazal L, Sanchez A, Garcia M, Brutti J, Cabrera MC, Miranda-Zazueta G, Rojas G, Cattaneo M, Castro-Narro G, Rubinstein F, Silva MO. Comparison of different prognostic scores for patients with cirrhosis hospitalized with SARS-CoV-2 infection. Ann Hepatol. 2021 Nov-Dec;25:100350. doi: 10.1016/j.aohep.2021.100350. Epub 2021 Apr 14.

  PMID: 33864948 DERIVED

• Mendizabal M, Pinero F, Ridruejo E, Anders M, Silveyra MD, Torre A, Montes P, Urzua A, Pages J, Toro LG, Diaz J, Gonzalez Ballerga E, Miranda-Zazueta G, Peralta M, Gutierrez I, Michelato D, Venturelli MG, Varon A, Vera-Pozo E, Tagle M, Garcia M, Tassara A, Brutti J, Ruiz Garcia S, Bustios C, Escajadillo N, Macias Y, Higuera-de la Tijera F, Gomez AJ, Dominguez A, Castillo-Barradas M, Contreras F, Scarpin A, Schinoni MI, Toledo C, Girala M, Mainardi V, Sanchez A, Bessone F, Rubinstein F, Silva MO. Prospective Latin American cohort evaluating outcomes of patients with COVID-19 and abnormal liver tests on admission. Ann Hepatol. 2021 Mar-Apr;21:100298. doi: 10.1016/j.aohep.2020.100298. Epub 2021 Jan 7.

  PMID: 33359234 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marcelo O Silva, MD

  Austral University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: April 24, 2020
• Study Start: April 15, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)