Infection ViralCCFNCT04344327
Early Risk Stratification of Patient Hospitalized for SARS-CoV2 Infection: Critical COVID-19 France CCF
An observational study of Infection Viral and Infection, Hospital, run by French Cardiology Society at 23 sites in France.
Trial summary
The COVID-19 pandemic of SARS CoV2 (Severe Acute Respiratory Syndrome, COVID-19) infection, which is currently evolving in France, raises many questions about the clinical and biological profile of infected hospitalized patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Viral, Infection, Hospital, COVID
- How many people
- 2,878 participants
- Where
- 23 sitesFrance
- Study dates
- 10 Apr 2020to 21 Apr 2020
- 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: Patients presenting to the hospital with COVID-19 infection
Who may be able to join
- Patients hospitalized in cardiology unit or medicine conventional sector with diagnosis of COVID-19 (positive PCR (Polymerase Chain Reaction) or diagnosis presumed by the clinical and radiographic picture)
Who cannot join
- Minors
- Pregnant women
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
CHU d'Amiens
Amiens, 80054
CHU Annecy
Annecy, 74374
CHU de Bordeaux
Bordeaux, 33404
CHU de Caen
Caen, 14033
Cotentin hospital
Cherbourg, 50100
CHU Dijon
Dijon, 21079
Elbeuf Louviers Val de Reuil
Elbeuf, 76500
CHU de Fréjus / Saint-Raphael
Fréjus, 83608
Lille Catholic Institute Hospital Group, Lille
Lille, 59000
CHU de Lyon
Lyon, 69229
APHM
Marseille, 13000
Jacques Cartier Private Hospital, Massy
Massy, 91300
CHR d'Orléans
Orléans
Bichat (APHP)
Paris, 75000
Georges Pompidou European Hospital (AP-HP)
Paris, 75000
Institut Mutualiste Montsouris, Paris
Paris, 75000
CHU de Reims
Reims, 51092
CHU de Rouen
Rouen, 76000
CHU Saint Etienne
Saint-Etienne, 42055
CHU de Strasbourg
Strasbourg, 67000
CHU de Toulouse
Toulouse, 31000
Saint Gatien hospital
Tours, 3540
CHU de Nancy
Vandœuvre-lès-Nancy, 54500
About this study
The COVID-19 pandemic of SARS CoV2 (Severe Acute Respiratory Syndrome, COVID-19) infection, which is currently evolving in France, raises many questions about the clinical and biological profile of infected hospitalized patients. If certain biological factors like troponin, BNP (Brain Natriuretic Peptid), or clinical factors like cardiovascular history or oncological history are associated with a worse prognosis, available data comes from studies in Asia for the majority, or including a limited number of patients. Patient stratification remains a major issue for patient sorting and early referral of patients.
Read the detailed description
This study is observational, multicenter and retrospective, and is conducted in hospitals in France.
Clinical data relating to history, comorbidities, risk factors, previous treatments, treatments during the hospitalization and treatments at the discharge from hospital, clinical parameters, biological and ultrasound cardiological data, procedures and events during hospitalization will be recorded, in order to identify the early predictors of clinical worsening in patients hospitalized for COVID-19 in cardiology or conventional medicine department.
- Conditions
- Infection Viral, Infection, Hospital, COVID
- Keywords
- Cardiology department, Medicine conventional department
- Medical subject headings
- Virus Diseases, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with COVID-19 | Patients hospitalized in conventional sector with diagnosis of COVID-19 (positive PCR (Polymerase Chain Reaction) or diagnosis presumed by the clinical and radiographic picture) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death rate
Analysis of all-cause death in relation with clinical patient profile
Measured: Through study completion, an average of 4 weeks
Transfer to intensive care unit
Correlation between clinical patient profile and transfer need to intensive care unit
Measured: Through study completion, an average of 4 weeks
Ventilation analysis
Type of ventilation procedures needed during the hospitalization (Orotracheal intubation for mechanical ventilation or Non-invasive ventilation or 29/5000 high flow oxygen therapy - Optiflow) in relation with clinical patient profile
Measured: Through study completion, an average of 4 weeks
Secondary outcomes (1)
Construction of a predictive score for COVID-19 severe form
Description of clinical and biological patient profile leading to a worse prognosis
Measured: Through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start10 Apr 2020
- Primary completion21 Apr 2020
- Study completion21 Apr 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 Infection 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
- Retrospective
- Enrolment
- 2,878 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume BONNET, MD, Study director, Hopital Européen Georges PompidouOrianne WEIZMAN, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344327
- Sponsor's protocol ID
- 2020-02
- Acronym
- CCF
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sutter W, Duceau B, Vignac M, Bonnet G, Carlier A, Roussel R, Trimaille A, Pommier T, Guilleminot P, Sagnard A, Pastier J, Weizman O, Giordano G, Cellier J, Geneste L, Panagides V, Marsou W, Deney A, Karsenty C, Attou S, Delmotte T, Ribeyrolles S, Chemaly P, Gautier A, Fauvel C, Chaumont C, Mika D, Pezel T, Cohen A, Potier L; Critical COVID-19 France Investigators. Association of diabetes and outcomes in patients with COVID-19: Propensity score-matched analyses from a French retrospective cohort. Diabetes Metab. 2021 Jul;47(4):101222. doi: 10.1016/j.diabet.2020.101222. Epub 2020 Dec 31.
PubMed 33388386
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Risk Stratification of Patient Hospitalized for SARS-CoV2 Infection: Critical COVID-19 France CCF
- ClinicalTrials.gov ID
- NCT04344327
- Acronym / sponsor ID
- CCF / 2020-02
- Conditions
- Infection Viral, Infection, Hospital, COVID
- Keywords
- Cardiology department, Medicine conventional department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,878 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 14 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.
The COVID-19 pandemic of SARS CoV2 (Severe Acute Respiratory Syndrome, COVID-19) infection, which is currently evolving in France, raises many questions about the clinical and biological profile of infected hospitalized patients. If certain biological factors like troponin, BNP (Brain Natriuretic Peptid), or clinical factors like cardiovascular history or oncological history are associated with a worse prognosis, available data comes from studies in Asia for the majority, or including a limited number of patients. Patient stratification remains a major issue for patient sorting and early referral of patients.
Detailed description
This study is observational, multicenter and retrospective, and is conducted in hospitals in France.
Clinical data relating to history, comorbidities, risk factors, previous treatments, treatments during the hospitalization and treatments at the discharge from hospital, clinical parameters, biological and ultrasound cardiological data, procedures and events during hospitalization will be recorded, in order to identify the early predictors of clinical worsening in patients hospitalized for COVID-19 in cardiology or conventional medicine department.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID-19 | – | –Patients hospitalized in conventional sector with diagnosis of COVID-19 (positive PCR (Polymerase Chain Reaction) or diagnosis presumed by the clinical and radiographic picture) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the hospital with COVID-19 infection
Key inclusion criteria (1 listed)
- Patients hospitalized in cardiology unit or medicine conventional sector with diagnosis of COVID-19 (positive PCR (Polymerase Chain Reaction) or diagnosis presumed by the clinical and radiographic picture)
Key exclusion criteria (2 listed)
- Minors
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death rate
Time frame: Through study completion, an average of 4 weeks
Analysis of all-cause death in relation with clinical patient profile
Transfer to intensive care unit
Time frame: Through study completion, an average of 4 weeks
Correlation between clinical patient profile and transfer need to intensive care unit
Ventilation analysis
Time frame: Through study completion, an average of 4 weeks
Type of ventilation procedures needed during the hospitalization (Orotracheal intubation for mechanical ventilation or Non-invasive ventilation or 29/5000 high flow oxygen therapy - Optiflow) in relation with clinical patient profile
1 secondary outcome
Construction of a predictive score for COVID-19 severe form
Time frame: Through study completion, an average of 4 weeks
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 28 Apr 2020.
- Derived from this study: PubMed 33388386Sutter W, Duceau B, Vignac M, Bonnet G, Carlier A, Roussel R, Trimaille A, Pommier T, Guilleminot P, Sagnard A, Pastier J, Weizman O, Giordano G, Cellier J, Geneste L, Panagides V, Marsou W, Deney A, Karsenty C, Attou S, Delmotte T, Ribeyrolles S, Chemaly P, Gautier A, Fauvel C, Chaumont C, Mika D, Pezel T, Cohen A, Potier L; Critical COVID-19 France Investigators. Association of diabetes and outcomes in patients with COVID-19: Propensity score-matched analyses from a French retrospective cohort. Diabetes Metab. 2021 Jul;47(4):101222. doi: 10.1016/j.diabet.2020.101222. Epub 2020 Dec 31.
- 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.
Guillaume BONNET, MD study director
Hopital Européen Georges Pompidou
Orianne WEIZMAN, MD principal investigator
Central Hospital, Nancy, France
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection Viral and Infection, Hospital, run by French Cardiology Society at 23 sites 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 1 inclusion and 2 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
Death rate (time frame: Through study completion, an average of 4 weeks). The study lists 3 primary outcomes in all. 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 NCT04344327, 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 28 Apr 2020.