COVID19-CHIEF: COVID-19 Infection in Patients With Hepatocellular Carcinoma

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Unknown status

CT.gov ID

NCT04367805

Collaborator

Centre Hospitalier-Universitaire Bondy (Other), University Hospital, Bordeaux (Other), Centre Hospitalier-Universitaire CLICHY (Other), Centre Hospitalier Général CORBEIL-ESSONNE (Other), CHU CRETEIL (Other), University Hospital, Grenoble (Other), University Hospital, Lille (Other), CHU LYON (Other), Poitiers University Hospital (Other), Rennes University Hospital (Other), University Hospital, Rouen (Other), University Hospital, Toulouse (Other), CHU VILLEJUIF (Other), Central Hospital, Nancy, France (Other), Centre Hospitalier Universitaire de Nice (Other), University Hospital, Montpellier (Other)

Enrollment

Location

5.2

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Since December 2019, a new disease named COVID-19 linked to a new coronavirus, SARS-CoV2 has emerged in China in the city of Wuhan, Hubei province, spreading very quickly to all 5 continents, and responsible for a pandemic. France is the third most affected country in Europe after Italy and Spain. Groups of patients at a higher risk of developing a severe form of COVID-19 have been defined: this include patients with immunosuppressive disease as cancer or patients with advanced cirrhosis of the liver. Coronavirus liver injury had been described with SARS-CoV 1 and MERS-CoV. There is no data on liver damage associated with COVID-19 infection for compensated or decompensated cirrhotic patients. The objectives of this project are to estimate the incidence of COVID-19 in hepatocellular carcinoma population, both hospital and ambulatory, and to study the impact on the frequency of severe forms, the prognosis, but also liver function, and the management of hepatocellular carcinoma, in this context of pandemic

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma COVID-19	Diagnostic Test: nasopharyngeal Covid 19 RT-PCR

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Impact of COVID-19 Infection in Patients With Hepatocellular Carcinoma: An Ambispective Study Nestled in the CHIEF Cohort

Actual Study Start Date :

Apr 27, 2020

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Oct 1, 2020

Outcome Measures

Primary Outcome Measures

Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France [6 months]
Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with CHC and included in the French national prospective cohort CHIEF
Hospital and ambulatory patients
Infection confirmed by COVID-19 defined by a positive nasopharyngeal PCR or if PCR COVID-19 negative : CT showing COVID-19 compatible pneumonia
Suspected COVID-19 infection, not confirmed by COVID-19 PCR or chest CT, with no other known cause of acute pneumonia.

Exclusion Criteria:

Patient refusal
Influenza only, confirmed by a diagnostic test
Other proven causes of pneumonia and absence of COVID-19

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT04367805

Other Study ID Numbers:

PI2020_843_0042

First Posted:

Apr 29, 2020

Last Update Posted:

Apr 29, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

Hepatocellular Carcinoma

COVID-19

Coronavirus disease 2019-Incidence

Additional relevant MeSH terms: