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COVID19-FOIE National Observatory

NCT04375670 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1132

Last updated 2022-08-09

No results posted yet for this study

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

Sponsors & Collaborators

  • Association Française pour l'Etude du Foie (AFEF)

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Nathalie Ganne-Carrié, MD-PhD · AP-HP, Jean Verdier Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-11
Primary Completion
2022-02-28
Completion
2022-05-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04375670 on ClinicalTrials.gov