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

April 24, 2020 updated by: French Cardiology Society
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2878

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU d'Amiens
      • Annecy, France, 74374
        • CHU Annecy
      • Bordeaux, France, 33404
        • CHU de Bordeaux
      • Caen, France, 14033
        • CHU de Caen
      • Cherbourg, France, 50100
        • Cotentin hospital
      • Dijon, France, 21079
        • CHU Dijon
      • Elbeuf, France, 76500
        • Elbeuf Louviers Val de Reuil
      • Fréjus, France, 83608
        • CHU de Fréjus / Saint-Raphael
      • Lille, France, 59000
        • Lille Catholic Institute Hospital Group, Lille
      • Lyon, France, 69229
        • Chu de Lyon
      • Marseille, France, 13000
        • APHM
      • Massy, France, 91300
        • Jacques Cartier Private Hospital, Massy
      • Orléans, France
        • CHR d'Orléans
      • Paris, France, 75000
        • Bichat (APHP)
      • Paris, France, 75000
        • Georges Pompidou European Hospital (AP-HP)
      • Paris, France, 75000
        • Institut Mutualiste Montsouris, Paris
      • Reims, France, 51092
        • CHU de Reims
      • Rouen, France, 76000
        • CHU de Rouen
      • Saint-Étienne, France, 42055
        • CHU Saint Etienne
      • Strasbourg, France, 67000
        • CHU de Strasbourg
      • Toulouse, France, 31000
        • CHU de Toulouse
      • Tours, France, 3540
        • Saint Gatien hospital
      • Vandœuvre-lès-Nancy, France, 54500
        • Chu de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients presenting to the hospital with COVID-19 infection

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death rate
Time Frame: Through study completion, an average of 4 weeks
Analysis of all-cause death in relation with clinical patient profile
Through study completion, an average of 4 weeks
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
Through study completion, an average of 4 weeks
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
Through study completion, an average of 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Study Director: Guillaume BONNET, MD, Hopital Europeen Georges Pompidou
  • Principal Investigator: Orianne WEIZMAN, MD, Chu de Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2020

Primary Completion (Actual)

April 21, 2020

Study Completion (Actual)

April 21, 2020

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 13, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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