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

Completed

• Conditions: Critically Ill; Pneumonia, Viral; Corona Virus Infection
• Interventions: Other: No intervention

• Registration Number: NCT04340466
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-03
• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-09
• Primary Completion: 2020-07-03
• Study Completion: 2020-07-03
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1003

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	No intervention	-
Suspected or proven COVID-19 critically ill patients	No intervention	-

Primary Outcome Measures

Name	Time	Method
Mortality at day 28	day 28	Mortality at day 28

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France