NCT04340466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,003

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2020

Completed
Last Updated

December 3, 2025

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

April 7, 2020

Last Update Submit

November 25, 2025

Conditions

Keywords

COVID-19SARS-Cov-2Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Mortality at day 28

    Mortality at day 28

    day 28

Secondary Outcomes (9)

  • severe complications

    up to day 28

  • Imaging

    day 1

  • Delay in Microbiological diagnosis

    day 1

  • Antiviral therapy

    up to day 28

  • Antibiotic therapy

    day 28

  • +4 more secondary outcomes

Study Arms (2)

Suspected or proven COVID-19 critically ill patients

Other: No intervention

Control

Other: No intervention

Interventions

No intervention

ControlSuspected or proven COVID-19 critically ill patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

  • Roger C, Collange O, Mezzarobba M, Abou-Arab O, Teule L, Garnier M, Hoffmann C, Muller L, Lefrant JY, Guinot PG, Novy E, Abraham P, Clavier T, Bourenne J, Besch G, Favier L, Fiani M, Ouattara A, Joannes-Boyau O, Fischer MO, Leone M, Ait Tamlihat Y, Pottecher J, Cordier PY, Aussant P, Moussa MD, Hautin E, Bouex M, Julia JM, Cady J, Danguy Des Deserts M, Mayeur N, Mura T, Allaouchiche B; AZUREA group. French multicentre observational study on SARS-CoV-2 infections intensive care initial management: the FRENCH CORONA study. Anaesth Crit Care Pain Med. 2021 Aug;40(4):100931. doi: 10.1016/j.accpm.2021.100931. Epub 2021 Jul 10.

MeSH Terms

Conditions

Pneumonia, ViralCritical IllnessCoronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Officials

  • CLAIRE ROGER

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 9, 2020

Study Start

April 3, 2020

Primary Completion

July 3, 2020

Study Completion

July 3, 2020

Last Updated

December 3, 2025

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations