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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344327
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
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.

Condition or disease
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.

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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 : April 10, 2020
Actual Primary Completion Date : April 21, 2020
Actual Study Completion Date : April 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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)



Primary Outcome Measures :
  1. Death rate [ Time Frame: Through study completion, an average of 4 weeks ]
    Analysis of all-cause death in relation with clinical patient profile

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to the hospital with COVID-19 infection
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:

  • Minors
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344327


Locations
Show Show 23 study locations
Sponsors and Collaborators
French Cardiology Society
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Study Director: Guillaume BONNET, MD Hopital Européen Georges Pompidou
Principal Investigator: Orianne WEIZMAN, MD CHU de Nancy
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Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT04344327    
Other Study ID Numbers: 2020-02
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by French Cardiology Society:
Cardiology department
Medicine conventional department
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cross Infection
Virus Diseases
Iatrogenic Disease
Disease Attributes
Pathologic Processes