COVID19-FOIE National Observatory

August 8, 2022 updated by: Assistance Publique - Hôpitaux de Paris

COVID19-FOIE National Observatory. An Ambispective Cohort Study of All Consecutive Patients

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.

Study Overview

Status

Completed

Conditions

Detailed Description

  1. Background and objectives:

    Coronavirus infection 2019 (COVID-19), linked to the SARS-Cov-2 virus, is rapidly spreading worldwide. After the city of Wuhan and the province of Hubei, European healthcare systems are facing an outbreak of seriously ill patients, but few are fully equipped to manage this health crisis.

    On the occasion of this pandemic, the hepatologist associations of United States , Europe and France as well as the French Federation of Digestive Cancer have proposed modalities for the management of patients with chronic liver disease likely to guarantee them maximum safety. The level of scientific evidence for these proposals is very low, given the small amount of objective clinical data available to date on the relationship between COVID-19 and liver.

    Some preliminary Chinese data indicates that:

    • 2-11% of patients treated for COVID19 had underlying chronic liver disease
    • an increase in transaminases is observed in 25-35% of patients, generally moderate (median 23-39 IU/L), with a higher rate in symptomatic and/or severe forms and/or requiring hospitalization in intensive care unit as well as in patients who later die . The mechanism involved is uncertain to date. Indeed, the data suggesting the possibility of localization of the virus in the liver are too preliminary, and it is reasonable to incriminate the elements of inflammatory reaction syndrome. Liver damage can be explained during these infections by hepatic hypoxia, related to a frequent viral myocarditis in this situation. Finally, other more classic causes may also be associated, including drug (paracetamol, antibiotics), or an exacerbation of an underlying chronic liver disease, known or unknown. Control of viral serologies B and C is therefore recommended in this situation.
    • elderly patients, patients with cirrhosis, patients with immune hepatitis under immunosuppressive drugs and patients before and after transplantation under immunosuppressive therapy would be the subjects most at risk of severe COVID19
    • very strict preventive measures have proven their effectiveness in terms of mortality in 111 patients with decompensated cirrhosis, including 2/3 hospitalized and 1/3 ambulatory.

    In this totally new and unexpected context, the board meeting of the AFEF proposes the national observatory COVID19-FOIE, intended to collect data of patients with liver disease (all stages combined) or liver transplants that developed COVID19 confirmed by PCR on nasopharyngeal sampling and/or thoracic CT.

  2. Population:

    All patients with acute or chronic liver disease treated by a member of the AFEF with an established diagnosis of COVID 19 confirmed by PCR on nasopharyngeal and/or thoracic CT.

  3. Methodology:

    This is an epidemiological, observational, prospective, descriptive, prognostic and evaluative observational cohort study. This study does not change the patient's management; it consists of analyzing clinical-biological data collected as part of the patient's usual follow-up.

  4. 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 this type, the etiology-ies of liver disease at the infection (viral hepatitis -B and/or C-, 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)

  5. Criteria:

    Primary criteria: mortality rate related to Covid-19 in patients with a chronic liver disease

    Secondary criteria:

    • mortality rate according the stage of fibrosis and the cirrhotic status defined with liver biopsy or non invasive tests of fibrosis or according the opinion of clinician
    • mortality related to Covid-19 according an history of hepatocellular carcinoma, an immunosuppressive treatment and this type (treatment related to a liver transplantation or to an auto-immune liver disease or to other indication), the etiology-ies of liver disease at the infection (viral hepatitis -B and/or C-, related to alcohol consumption, metabolic syndrome, hemochromatosis, immune liver disease, other or unknown), and comorbidities, particularly diabetes, hypertension, overweight -BMI from 26 to 30- or obesity-BMI > 30)
    • Incidence of liver complications (acute hepatitis, liver insufficiency, decompensation of cirrhosis, encephalopathy, renal insufficiency)

  6. Effective and duration of the study:

    All consecutive patients included in the observatory with registered data in the eCRF until 31/12/20.

  7. Population of the study:

    • 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
    • Non inclusion criteria: age equal or higher 18 years
  8. Conduct of the research:

After informing patients and making available a non opposition form, the main demographic and clinical data related to a chronic liver disease, in one hand and, on the other hand, the COVID19, already collected in the patient's medical record will be collected in a dedicated eCRF. All contributors will be associated with the publications resulting from this observatory and the COVID-Foie working group.

Study Type

Observational

Enrollment (Actual)

1132

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

  • France
      • Bondy, France, 93140
        • Ganne

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality rate related to Covid-19 in patients with a chronic liver disease
Time Frame: Up to 30 days
Up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Time Frame: Up to 30 days
Up to 30 days
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
through patient follow-up, an average of 1 year

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Association Française pour l'Etude du Foie (AFEF)

Investigators

  • Principal Investigator: Nathalie Ganne-Carrié, MD-PhD, AP-HP, Jean Verdier Hospital

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)

May 11, 2020

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006477

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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