COVID-19 Infection in Patients With Hepatocellular Carcinoma

Active, not recruiting

• Conditions: COVID-19; Hepatocellular Carcinoma

• Registration Number: NCT04367805
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-27
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Primary Completion: 2023-10-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France