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Clinical Trials/NCT04344327
NCT04344327
Completed
Not Applicable

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

French Cardiology Society23 sites in 1 country2,878 target enrollmentApril 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infection Viral
Sponsor
French Cardiology Society
Enrollment
2878
Locations
23
Primary Endpoint
Death rate
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 10, 2020
End Date
April 21, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
French Cardiology Society
Responsible Party
Sponsor

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

  • Pregnant women

Outcomes

Primary Outcomes

Death rate

Time Frame: Through study completion, an average of 4 weeks

Analysis of all-cause death in relation with clinical patient profile

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

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

Secondary Outcomes

  • Construction of a predictive score for COVID-19 severe form(Through study completion, an average of 4 weeks)

Study Sites (23)

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