Hepatocellular CarcinomaCOVID19-CHIEFNCT04367805
COVID-19 Infection in Patients With Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma and COVID-19, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, COVID-19
- What is being tested?
- nasopharyngeal Covid 19 RT-PCR
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2020to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hepatocellular carcinoma population, both hospital and ambulatory
Who may be able to join
- 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.
Who cannot join
- Patient refusal
- Influenza only, confirmed by a diagnostic test
- Other proven causes of pneumonia and absence of COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of COVID-19 Infection in Patients With Hepatocellular Carcinoma: An Ambispective Study Nestled in the CHIEF Cohort
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
- Conditions
- Hepatocellular Carcinoma, COVID-19
- Being tested
- nasopharyngeal Covid 19 RT-PCR
- Keywords
- Hepatocellular Carcinoma, COVID-19, Coronavirus disease 2019-Incidence
- Medical subject headings
- Carcinoma, Hepatocellular, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal Covid 19 RT-PCRDiagnostic test
nasopharyngeal Covid 19 RT-PCR
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France
Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start22 May 2020
- Primary completion1 Feb 2024
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier-Universitaire Bondy, University Hospital, Bordeaux, Centre Hospitalier-Universitaire CLICHY, Centre Hospitalier Général CORBEIL-ESSONNE, CHU CRETEIL, University Hospital, Grenoble, University Hospital, Lille, Hospices Civils de Lyon, Poitiers University Hospital, Rennes University Hospital, University Hospital, Rouen, University Hospital, Toulouse, CHU VILLEJUIF, Central Hospital, Nancy, France, Centre Hospitalier Universitaire de Nice, University Hospital, Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367805
- Sponsor's protocol ID
- PI2020_843_0042
- Acronym
- COVID19-CHIEF
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2020
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Infection in Patients With Hepatocellular Carcinoma: An Ambispective Study Nestled in the CHIEF Cohort
- ClinicalTrials.gov ID
- NCT04367805
- Acronym / sponsor ID
- COVID19-CHIEF / PI2020_843_0042
- Conditions
- Hepatocellular Carcinoma, COVID-19
- Keywords
- Hepatocellular Carcinoma, COVID-19, Coronavirus disease 2019-Incidence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier-Universitaire Bondy, University Hospital, Bordeaux, Centre Hospitalier-Universitaire CLICHY, Centre Hospitalier Général CORBEIL-ESSONNE, CHU CRETEIL, University Hospital, Grenoble, University Hospital, Lille, Hospices Civils de Lyon, Poitiers University Hospital, Rennes University Hospital, University Hospital, Rouen, University Hospital, Toulouse, CHU VILLEJUIF, Central Hospital, Nancy, France, Centre Hospitalier Universitaire de Nice, University Hospital, Montpellier
- Study start
- 22 May 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hepatocellular carcinoma population, both hospital and ambulatory
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient refusal
- Influenza only, confirmed by a diagnostic test
- Other proven causes of pneumonia and absence of COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasopharyngeal Covid 19 RT-PCRnasopharyngeal Covid 19 RT-PCR | Diagnostic test | – |
Primary outcome
Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France
Time frame: 6 months
Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and COVID-19, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of COVID-19 infection in patients with hepatocellular carcinoma in France (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.