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

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ClinicalTrials.gov Identifier: NCT04340466
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Pneumonia, Viral Critically Ill Corona Virus Infection Other: No intervention

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


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

Control Other: No intervention
No intervention




Primary Outcome Measures :
  1. Mortality at day 28 [ Time Frame: day 28 ]
    Mortality at day 28


Secondary Outcome Measures :
  1. 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

  2. Imaging [ Time Frame: day 1 ]
    Delay in imaging in hours

  3. Delay in Microbiological diagnosis [ Time Frame: day 1 ]
    delay in microbiological diagnosis in hours

  4. Antiviral therapy [ Time Frame: up to day 28 ]
    Antiviral therapy Yes / no

  5. Antibiotic therapy [ Time Frame: day 28 ]
    Antibiotic therapy Yes / No

  6. Covid-19 treatments [ Time Frame: up to day 28 ]
    Covid-19 treatments Yes / No

  7. Patients receiving renal replacement therapy [ Time Frame: up to day 28 ]
    number

  8. Patients receiving mechanical ventilation [ Time Frame: up to day 28 ]
    number

  9. Vital status [ Time Frame: day 28 ]
    Patient alive at day 28 : yes / No



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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:   Non-Probability Sample
Study Population
The target population of the study is all patients with suspected or proven SARS-Cov-2 infection (COVID-19)
Criteria

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

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): NCT04340466


Contacts
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Contact: CLAIRE ROGER, MD, PhD 0033466683050 claire.roger@chu-nimes.fr
Contact: Anissa MEGZARI drc@chu-nimes.fr

Locations
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France
CHU Nimes Recruiting
Nîmes, France, 30029
Contact: Claire Roger, MD, PhD    +33466683331    claire.roger@chu-nimes.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: CLAIRE ROGER Nimes University Hospital
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04340466    
Other Study ID Numbers: 2020-A00797-32
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 14, 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 Centre Hospitalier Universitaire de Nīmes:
COVID-19
SARS-Cov-2
Intensive Care Unit
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia, Viral
Pneumonia
Critical Illness
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections