COVID19-FOIE National Observatory

NCT04375670 | Completed

• 1 other identifier: IRB00006477
• Study Type: observational
• Target: 1,132
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The COVID19 and liver relationships are very rare. The preliminary Chinese data indicate that 2-11% of patients treated for COVID19 had an underlying chronic liver disease. However, there is no clinical data on morbi-mortality in this context. Objectives: Primary Objective: Evaluate the mortality related to Covid-19 in patients with a chronic liver disease Secondary objectives:

• Evaluate the mortality (liver-related and no liver-related) due to the Covid-19 according to the cirrhotic status, an history of hepatocellular carcinoma, an immunosuppressive treatment and its type, the etiology-ies of liver disease at the diagnosis of Covid-19 (viral hepatitis -B and/or C-, liver disease related to alcohol consumption, metabolic syndrome, hemochromatosis, immune liver disease, other or unknown), and comorbidities
• Evaluate the liver morbidity related to Covid-19, including
• incidence of liver biochemical abnormalities in patients with normal liver enzymes values or of a 2-fold increase of usual values for AST, ALT, GGT, Alcalines Phosphatasis
• incidence of liver complications (acute hepatitis, liver insufficiency, decompensation of cirrhosis, encephalopathy, renal insufficiency) Patients: All patients with a liver disease (chronic or acute) with a positive diagnosis of Covid-19 assessed either by positive PCR or specific thoracic abnormalities at TDM Methodology: Observational ambispective study consisting exclusively of a collection of data from patients with liver diseases and managed for COVID 19 The data is collected and transcribed on a secure electronic eCRF hosted at the Assitance Publique des Hôpitaux de Paris and accessible online from the AFEF website Duration and organisation of the research: After information of the patients and making available a non-opposition form, the main demographic and clinical data related to the liver disease and to the COVID19 already collected in the patient's medical record will be collected in a dedicated e-CRF. Effective of the study: All consecutive patients included in the study whose data are collected e-CRF until 31/12/2020.

Conditions

Liver Diseases; COVID19

Keywords

Mortality; Fibrosis; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Mortality rate related to Covid-19 in patients with a chronic liver disease

  Up to 30 days

Secondary Outcomes (3)

• mortality rate according the stage of fibrosis and the cirrhotic status

  Up to 30 days

• mortality related to Covid-19 according an history of hepatocellular carcinoma, an immunosuppressive treatment and this type the etiology-ies of liver disease at the infection and comorbidities.

  Up to 30 days

• Incidence of liver complications

  through patient follow-up, an average of 1 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a liver disease (chronic or acute) with a positive diagnosis of Covid-19 assessed either by positive PCR or specific thoracic abnormalities at TDM

You may qualify if:

• All patients with acute or chronic liver disease managed by a member of AFEF with positive diagnosis of COVID-19 by PCR and/or specific abnormalities at the thoracic TDM
• Patients with history of liver transplantation
• Patients affiliated with social security

You may not qualify if:

• Age inferior to 18 years

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Association Française pour l'Etude du Foie (AFEF): collaborator

Study Sites (1)

Ganne

Bondy, 93140, France

Location

Related Publications (7)

• 1. Clinical Insights for Hepatology and Liver Transplant Providers During the COVID-19 Pandemic.https://www.aasld.org/sites/default/files/2020-03/AASLD-COVID19-ClinicalInsights-3.23.2020-FINAL-v2.pdf

  BACKGROUND

• Boettler T, Newsome PN, Mondelli MU, Maticic M, Cordero E, Cornberg M, Berg T. Care of patients with liver disease during the COVID-19 pandemic: EASL-ESCMID position paper. JHEP Rep. 2020 Jun;2(3):100113. doi: 10.1016/j.jhepr.2020.100113. Epub 2020 Apr 2.

  PMID: 32289115 BACKGROUND

• Di Fiore F, Bouche O, Lepage C, Sefrioui D, Gangloff A, Schwarz L, Tuech JJ, Aparicio T, Lecomte T, Boulagnon-Rombi C, Lievre A, Manfredi S, Phelip JM, Michel P; Thesaurus National de Cancerologie Digestive (TNCD); Societe Nationale Francaise de Gastroenterologie (SNFGE); Federation Francophone de Cancerologie Digestive (FFCD); Groupe Cooperateur multidisciplinaire en Oncologie (GERCOR); Federation Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Societe Francaise de Chirurgie Digestive (SFCD); Societe Francaise d'Endoscopie Digestive (SFED); Societe Francaise de Radiotherapie Oncologique (SFRO) and Societe Francaise de Radiologie (SFR); Association Chirurgie Hepato-Biliaire et Transplantation (ACHBT). COVID-19 epidemic: Proposed alternatives in the management of digestive cancers: A French intergroup clinical point of view (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, SFR). Dig Liver Dis. 2020 Jun;52(6):597-603. doi: 10.1016/j.dld.2020.03.031. Epub 2020 May 14.

  PMID: 32418773 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

• Xu L, Liu J, Lu M, Yang D, Zheng X. Liver injury during highly pathogenic human coronavirus infections. Liver Int. 2020 May;40(5):998-1004. doi: 10.1111/liv.14435. Epub 2020 Mar 30.

  PMID: 32170806 BACKGROUND

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

• Xiao Y, Pan H, She Q, Wang F, Chen M. Prevention of SARS-CoV-2 infection in patients with decompensated cirrhosis. Lancet Gastroenterol Hepatol. 2020 Jun;5(6):528-529. doi: 10.1016/S2468-1253(20)30080-7. Epub 2020 Mar 17. No abstract available.

  PMID: 32197093 BACKGROUND

MeSH Terms

Conditions

Liver Diseases; COVID-19; Fibrosis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Nathalie Ganne-Carrié, MD-PhD

  AP-HP, Jean Verdier Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 5, 2020
• Study Start: May 11, 2020
• Primary Completion: February 28, 2022
• Study Completion: May 31, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)