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

Sponsor

French Cardiology Society (Other)

Overall Status

Completed

CT.gov ID

NCT04344327

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

2,878

Enrollment

Locations

Actual Duration (Days)

125.1

Patients Per Site

346.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection Viral Infection, Hospital COVID

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

Study Type:

Observational

Actual Enrollment :

2878 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 10, 2020

Actual Primary Completion Date :

Apr 21, 2020

Actual Study Completion Date :

Apr 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

Death rate [Through study completion, an average of 4 weeks]
Analysis of all-cause death 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
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU d'Amiens	Amiens	France	80054
2	CHU Annecy	Annecy	France	74374
3	CHU de Bordeaux	Bordeaux	France	33404
4	CHU de Caen	Caen	France	14033
5	Cotentin hospital	Cherbourg	France	50100
6	CHU Dijon	Dijon	France	21079
7	Elbeuf Louviers Val de Reuil	Elbeuf	France	76500
8	CHU de Fréjus / Saint-Raphael	Fréjus	France	83608
9	Lille Catholic Institute Hospital Group, Lille	Lille	France	59000
10	CHU de Lyon	Lyon	France	69229
11	APHM	Marseille	France	13000
12	Jacques Cartier Private Hospital, Massy	Massy	France	91300
13	CHR d'Orléans	Orléans	France
14	Bichat (APHP)	Paris	France	75000
15	Georges Pompidou European Hospital (AP-HP)	Paris	France	75000
16	Institut Mutualiste Montsouris, Paris	Paris	France	75000
17	CHU de Reims	Reims	France	51092
18	CHU de Rouen	Rouen	France	76000
19	CHU Saint Etienne	Saint-Étienne	France	42055
20	CHU de Strasbourg	Strasbourg	France	67000
21	CHU de Toulouse	Toulouse	France	31000
22	Saint Gatien hospital	Tours	France	3540
23	CHU de Nancy	Vandœuvre-lès-Nancy	France	54500