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

Corona Virus Infection Clinical Trial

— FRENCH CORONA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340466
• Other study ID #: 2020-A00797-32
• Status: Completed
• Start date: April 3, 2020
• Est. completion date: July 3, 2020

Study information

• Verified date: December 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1003
• Est. completion date: July 3, 2020
• Est. primary completion date: July 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• Critical Illness
• Critically Ill
• Infection
• Pneumonia
• Pneumonia, Viral
• Severe Acute Respiratory Syndrome

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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