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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04367805
Other study ID # PI2020_843_0042
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 27, 2020
Est. completion date October 2024

Study information

Verified date April 2024
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 23
Est. completion date October 2024
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Diagnostic Test:
nasopharyngeal Covid 19 RT-PCR
nasopharyngeal Covid 19 RT-PCR

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (17)

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

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France 6 months
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