NCT04375670

COVID19-FOIE National Observatory

Completed Last updated 9 August 2022

What this trial tests

trial in Liver Diseases in 1,132 participants. Completed in 31 May 2022.

Timeline

11 May 2020

Primary endpoint
28 February 2022

31 May 2022

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,132
Start date	11 May 2020
Primary completion	28 February 2022
Estimated completion	31 May 2022
Sites	1 location across France

Conditions studied

• Liver Diseases — all drugs for Liver Diseases →
• COVID19 — all drugs for COVID19 →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 80, any sex, with Liver Diseases or COVID19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Epidemiology and Disease Burden of Alcohol Associated Liver Disease.
   Aslam A, Kwo PY. · · 2023 · cited 62× · PMID 36647400 · DOI 10.1016/j.jceh.2022.09.001