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COVID19-FOIE National Observatory

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ClinicalTrials.gov Identifier: NCT04375670
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
Association Française pour l'Etude du Foie (AFEF)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease
Liver Diseases COVID19

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: COVID19-FOIE National Observatory. An Ambispective Cohort Study of All Consecutive Patients
Actual Study Start Date : May 11, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases




Primary Outcome Measures :
  1. Mortality rate related to Covid-19 in patients with a chronic liver disease [ Time Frame: Up to 30 days ]

Secondary Outcome Measures :
  1. mortality rate according the stage of fibrosis and the cirrhotic status [ Time Frame: Up to 30 days ]
    defined with liver biopsy or non invasive tests of fibrosis or according the opinion of clinician

  2. 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. [ Time Frame: Up to 30 days ]
  3. Incidence of liver complications [ Time Frame: through patient follow-up, an average of 1 year ]
    acute hepatitis, liver insufficiency, decompensation of cirrhosis, encephalopathy, renal insufficiency



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age inferior to 18 years

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): NCT04375670


Contacts
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Contact: Nathalie Ganne-Carrié, MD-PhD 0148026294 ext +33 nathalie.ganne@aphp.fr

Locations
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France
Ganne Recruiting
Bondy, France, 93140
Contact: Nathalie Ganne, MD-PhD    0148026294 ext 0033    nathalie.ganne@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Association Française pour l'Etude du Foie (AFEF)
Investigators
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Principal Investigator: Nathalie Ganne-Carrié, MD-PhD AP-HP, Jean Verdier Hospital
Publications:
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
Di Fiore F, Bouché O, Lepage C, Sefrioui D, Gangloff A, Schwarz L, Tuech JJ, Aparicio T, Lecomte T, Boulagnon-Rombi C, Lièvre A, Manfredi S, Phelip JM, Michel P; Thésaurus National de Cancérologie Digestive (TNCD); Société Nationale Française de Gastroentérologie (SNFGE); Fédération Francophone de Cancérologie Digestive (FFCD); Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR); Fédération Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Société Française de Chirurgie Digestive (SFCD); Société Française d'Endoscopie Digestive (SFED); Société Française de Radiothérapie Oncologique (SFRO) and Société Française 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.

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04375670    
Other Study ID Numbers: IRB00006477
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 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 Assistance Publique - Hôpitaux de Paris:
Mortality
Fibrosis
Hepatocellular Carcinoma
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases