Pneumonia, ViralFRENCH CORONANCT04340466
French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management Study
An observational study of Pneumonia, Viral and Critically Ill, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Viral, Critically Ill, Corona Virus Infection
- How many people
- 1,003 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2020to 3 Jul 2020
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The target population of the study is all patients with suspected or proven SARS-Cov-2 infection (COVID-19)
Who may be able to join
- Patients admitted to ICU for suspected or proven SARS-Cov-2 infection, defined by positive SARS-Cov-2 PCR or CT scan images
- Patient > or= 18 years
Who cannot join
- Patient study refusal
- Patient already enrolled in the present study
- Patient with respiratory illness with negative COVID-19 CT scan images and negative COVID_19 PCR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study
Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France.
We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.
- Conditions
- Pneumonia, Viral, Critically Ill, Corona Virus Infection
- Being tested
- No intervention
- Keywords
- COVID-19, SARS-Cov-2, Intensive Care Unit
- Medical subject headings
- Pneumonia, Viral, Critical Illness, Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Suspected or proven COVID-19 critically ill patients | Not described Receives: Other: No intervention | |
| Control | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at day 28
Mortality at day 28
Measured: day 28
Secondary outcomes (9)
severe complications
severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No
Measured: up to day 28
Imaging
Delay in imaging in hours
Measured: day 1
Delay in Microbiological diagnosis
delay in microbiological diagnosis in hours
Measured: day 1
Antiviral therapy
Antiviral therapy Yes / no
Measured: up to day 28
Antibiotic therapy
Antibiotic therapy Yes / No
Measured: day 28
Covid-19 treatments
Covid-19 treatments Yes / No
Measured: up to day 28
Patients receiving renal replacement therapy
number
Measured: up to day 28
Patients receiving mechanical ventilation
number
Measured: up to day 28
Vital status
Patient alive at day 28 : yes / No
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start3 Apr 2020
- Primary completion3 Jul 2020
- Study completion3 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, ViralStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,003 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CLAIRE ROGER, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340466
- Sponsor's protocol ID
- 2020-A00797-32
- Other IDs
- 2020-A00797-32
- Acronym
- FRENCH CORONA
- Status last verified
- Dec 2020
- First submitted
- 7 Apr 2020
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roger C, Collange O, Mezzarobba M, Abou-Arab O, Teule L, Garnier M, Hoffmann C, Muller L, Lefrant JY, Guinot PG, Novy E, Abraham P, Clavier T, Bourenne J, Besch G, Favier L, Fiani M, Ouattara A, Joannes-Boyau O, Fischer MO, Leone M, Ait Tamlihat Y, Pottecher J, Cordier PY, Aussant P, Moussa MD, Hautin E, Bouex M, Julia JM, Cady J, Danguy Des Deserts M, Mayeur N, Mura T, Allaouchiche B; AZUREA group. French multicentre observational study on SARS-CoV-2 infections intensive care initial management: the FRENCH CORONA study. Anaesth Crit Care Pain Med. 2021 Aug;40(4):100931. doi: 10.1016/j.accpm.2021.100931. Epub 2021 Jul 10.
PubMed 34256165
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study
- ClinicalTrials.gov ID
- NCT04340466
- Acronym / sponsor ID
- FRENCH CORONA / 2020-A00797-32
- Conditions
- Pneumonia, Viral, Critically Ill, Corona Virus Infection
- Keywords
- COVID-19, SARS-Cov-2, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 9 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 agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France.
We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected or proven COVID-19 critically ill patients | – | Other: No intervention |
| Control | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population of the study is all patients with suspected or proven SARS-Cov-2 infection (COVID-19)
Key inclusion criteria (2 listed)
- Patients admitted to ICU for suspected or proven SARS-Cov-2 infection, defined by positive SARS-Cov-2 PCR or CT scan images
- Patient > or= 18 years
Key exclusion criteria (3 listed)
- Patient study refusal
- Patient already enrolled in the present study
- Patient with respiratory illness with negative COVID-19 CT scan images and negative COVID_19 PCR
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 |
|---|---|---|
| No interventionNo intervention | Other | Control, Suspected or proven COVID-19 critically ill patients |
Primary outcome
Mortality at day 28
Time frame: day 28
Mortality at day 28
9 secondary outcomes
severe complications
Time frame: up to day 28
Imaging
Time frame: day 1
Delay in Microbiological diagnosis
Time frame: day 1
Antiviral therapy
Time frame: up to day 28
Antibiotic therapy
Time frame: day 28
Covid-19 treatments
Time frame: up to day 28
Patients receiving renal replacement therapy
Time frame: up to day 28
Patients receiving mechanical ventilation
Time frame: up to day 28
Vital status
Time frame: day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 34256165Roger C, Collange O, Mezzarobba M, Abou-Arab O, Teule L, Garnier M, Hoffmann C, Muller L, Lefrant JY, Guinot PG, Novy E, Abraham P, Clavier T, Bourenne J, Besch G, Favier L, Fiani M, Ouattara A, Joannes-Boyau O, Fischer MO, Leone M, Ait Tamlihat Y, Pottecher J, Cordier PY, Aussant P, Moussa MD, Hautin E, Bouex M, Julia JM, Cady J, Danguy Des Deserts M, Mayeur N, Mura T, Allaouchiche B; AZUREA group. French multicentre observational study on SARS-CoV-2 infections intensive care initial management: the FRENCH CORONA study. Anaesth Crit Care Pain Med. 2021 Aug;40(4):100931. doi: 10.1016/j.accpm.2021.100931. Epub 2021 Jul 10.
- 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.
CLAIRE ROGER principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Pneumonia, Viral and Critically Ill, run by Centre Hospitalier Universitaire de Nīmes 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 2 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: finished, as of the sponsor's last update on 3 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality at day 28 (time frame: day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04340466, which also lists 1 linked publication.
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 3 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.