French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management Study

Study Overview
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Brief Summary
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Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France. We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.

Official Title
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French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study

Conditions
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Pneumonia, Viral, Critically Ill, Corona Virus Infection

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to ICU for suspected or proven SARS-Cov-2 infection, defined by positive SARS-Cov-2 PCR or CT scan images Patient > or= 18 years Exclusion Criteria: Patient study refusal Patient already enrolled in the present study Patient with respiratory illness with negative COVID-19 CT scan images and negative COVID_19 PCR

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected or proven COVID-19 critically ill patients<br> | Other: No intervention<br>* No intervention<br>|
| Control<br> | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at day 28 | Mortality at day 28 | day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severe complications | severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No | up to day 28 | 
| Imaging | Delay in imaging in hours | day 1 | 
| Delay in Microbiological diagnosis | delay in microbiological diagnosis in hours | day 1 | 
| Antiviral therapy | Antiviral therapy Yes / no | up to day 28 | 
| Antibiotic therapy | Antibiotic therapy Yes / No | day 28 | 
| Covid-19 treatments | Covid-19 treatments Yes / No | up to day 28 | 
| Patients receiving renal replacement therapy | number | up to day 28 | 
| Patients receiving mechanical ventilation | number | up to day 28 | 
| Vital status | Patient alive at day 28 : yes / No | day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-Cov-2, Intensive Care Unit