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

Completed

• Conditions: Infection Viral; Infection, Hospital; COVID

• Registration Number: NCT04344327
• Lead Sponsor: French Cardiology Society

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.

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-09
• Study Start: 2020-04-10
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-14
• Primary Completion: 2020-04-21
• Study Completion: 2020-04-21
• Last Update Submitted: 2020-04-24
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2878

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death rate	Through study completion, an average of 4 weeks	Analysis of all-cause death in relation with clinical patient profile
Ventilation analysis	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
Transfer to intensive care unit	Through study completion, an average of 4 weeks	Correlation between clinical patient profile and transfer need to intensive care unit

Secondary Outcome Measures

Name	Time	Method
Construction of a predictive score for COVID-19 severe form	Through study completion, an average of 4 weeks	Description of clinical and biological patient profile leading to a worse prognosis

Trial Locations

Locations (23)

Saint Gatien hospital; 🇫🇷 Tours, 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

CHU de Fréjus / Saint-Raphael; 🇫🇷 Fréjus, France

Lille Catholic Institute Hospital Group, Lille; 🇫🇷 Lille, France

CHU de Lyon; 🇫🇷 Lyon, France

Jacques Cartier Private Hospital, Massy; 🇫🇷 Massy, France

APHM; 🇫🇷 Marseille, France

CHR d'Orléans; 🇫🇷 Orléans, 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 de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Toulouse; 🇫🇷 Toulouse, France

CHU de Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France

Bichat (APHP); 🇫🇷 Paris, France

Elbeuf Louviers Val de Reuil; 🇫🇷 Elbeuf, France

CHU Saint Etienne; 🇫🇷 Saint-Étienne, France