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

December 17, 2020 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1003

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
      • Nîmes, France, 30029
        • CHU Nîmes

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

Non-Probability Sample

Study Population

The target population of the study is all patients with suspected or proven SARS-Cov-2 infection (COVID-19)

Description

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 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: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Other: No intervention
No intervention
Suspected or proven COVID-19 critically ill patients
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at day 28
Time Frame: day 28
Mortality at day 28
day 28

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: CLAIRE ROGER, Centre Hospitalier Universitaire de Nîmes

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 3, 2020

Primary Completion (Actual)

July 3, 2020

Study Completion (Actual)

July 3, 2020

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00797-32

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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