Early Risk Stratification of Patient Hospitalized for SARS-CoV2 Infection: Critical COVID-19 France CCF

COVID Clinical Trial

— CCF  

Official title:

Early Risk Stratification of Patient Hospitalized for SARS-CoV2 Infection: Critical COVID-19 France CCF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04344327
• Other study ID #: 2020-02
• Status: Completed
• Start date: April 10, 2020
• Est. completion date: April 21, 2020

Study information

• Verified date: April 2020
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2878
• Est. completion date: April 21, 2020
• Est. primary completion date: April 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID
• Cross Infection
• Infection
• Infection Viral
• Infection, Hospital
• Virus Diseases

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	CHU Annecy	Annecy
France	CHU de Bordeaux	Bordeaux
France	CHU de Caen	Caen
France	Cotentin hospital	Cherbourg
France	CHU Dijon	Dijon
France	Elbeuf Louviers Val de Reuil	Elbeuf
France	CHU de Fréjus / Saint-Raphael	Fréjus
France	Lille Catholic Institute Hospital Group, Lille	Lille
France	CHU de Lyon	Lyon
France	APHM	Marseille
France	Jacques Cartier Private Hospital, Massy	Massy
France	CHR d'Orléans	Orléans
France	Bichat (APHP)	Paris
France	Georges Pompidou European Hospital (AP-HP)	Paris
France	Institut Mutualiste Montsouris, Paris	Paris
France	CHU de Reims	Reims
France	CHU de Rouen	Rouen
France	CHU Saint Etienne	Saint-Étienne
France	CHU de Strasbourg	Strasbourg
France	CHU de Toulouse	Toulouse
France	Saint Gatien hospital	Tours
France	CHU de Nancy	Vandœuvre-lès-Nancy

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death rate	Analysis of all-cause death in relation with clinical patient profile	Through study completion, an average of 4 weeks
Primary	Transfer to intensive care unit	Correlation between clinical patient profile and transfer need to intensive care unit	Through study completion, an average of 4 weeks
Primary	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	Through study completion, an average of 4 weeks
Secondary	Construction of a predictive score for COVID-19 severe form	Description of clinical and biological patient profile leading to a worse prognosis	Through study completion, an average of 4 weeks