Clinical trial NCT04344327: Early Risk Stratification of Patient Hospitalized for SARS-CoV2 Infection: Critical COVID-19 France CCF
Official title: Early Risk Stratification of Patient Hospitalized for SARS-CoV2 Infection: Critical COVID-19 France CCF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection Viral
Infection, Hospital
COVID
Keywords: Cardiology department
Medicine conventional department
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-04-14
Enrollment: 2878
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to the hospital with COVID-19 infection

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

- 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)

Exclusion Criteria:

* Minors
* Pregnant women

Primary outcomes:
measure: Death rate
timeFrame: Through study completion, an average of 4 weeks
measure: Transfer to intensive care unit
timeFrame: Through study completion, an average of 4 weeks
measure: Ventilation analysis
timeFrame: Through study completion, an average of 4 weeks
Secondary outcomes:
measure: Construction of a predictive score for COVID-19 severe form
timeFrame: Through study completion, an average of 4 weeks
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Annecy
country: France
facility: CHU Annecy
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Caen
country: France
facility: CHU de Caen
city: Cherbourg
country: France
facility: Cotentin hospital
city: Dijon
country: France
facility: CHU Dijon
city: Elbeuf
country: France
facility: Elbeuf Louviers Val de Reuil
city: Fréjus
country: France
facility: CHU de Fréjus / Saint-Raphael
city: Lille
country: France
facility: Lille Catholic Institute Hospital Group, Lille
city: Lyon
country: France
facility: CHU de Lyon
city: Marseille
country: France
facility: APHM
city: Massy
country: France
facility: Jacques Cartier Private Hospital, Massy
city: Orléans
country: France
facility: CHR d'Orléans
city: Paris
country: France
facility: Bichat (APHP)
city: Paris
country: France
facility: Georges Pompidou European Hospital (AP-HP)
city: Paris
country: France
facility: Institut Mutualiste Montsouris, Paris
city: Reims
country: France
facility: CHU de Reims
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: Saint Gatien hospital
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Nancy
Study officials:
affiliation: Hopital Européen Georges Pompidou
name: Guillaume BONNET, MD
role: STUDY_DIRECTOR
affiliation: Central Hospital, Nancy, France
name: Orianne WEIZMAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.