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Completed

NCT Number: NCT04340466

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Mortality at day 28

    Time frame: day 28

    Mortality at day 28

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: FRENCH CORONA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2020
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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