- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04354558
French Single Centre Experience of Critically Ill Patients With Covid 19 (CovidAmiens20)
March 21, 2023 updated by: Centre Hospitalier Universitaire, Amiens
Epidemiology and Outcomes of Critically Ill Patients With Covid 19: a French Single Centre Experience
Since the outbreak of a syndrome of acute respiratory distress associated to a novel coronavirus 2 (SARS-Cov2) that began in China, Europe and France have to face a sanitary emergency with critically care support when the patient evolves to an acute respiratory distress (ARDS).
In the context of supply shortages (ventilators, bed capacities) that countries have to deal with, data were lacking of characteristics and outcomes of patients admitted to intensive care unit (ICU).
the purpose of this project is to report the epidemiology and the outcomes of a French cohort of critically ill patients with SARS-Cov2
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Osama Abou Arab, MD
- Phone Number: (33)3 22 08 78 36
- Email: abouarab.osama@chu-amiens.fr
Study Locations
-
-
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Amiens, France, 80480
- Recruiting
- CHU Amiens
-
-
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
Critically ill patients with SARS Cov2 admitted in ICU
Description
Inclusion Criteria:
- 18 years old
- patient with positive rRT PCR of SARS Cov2 on a sample of nasopharyngeal swab
- admission in intensive care unit
Exclusion Criteria:
- patient under 18 years old
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
Cohorts and Interventions
Group / Cohort |
---|
survival patients
The cohort will be dichotomised in survival/non-survival groups according to the issue during ICU stay
|
non-survival patients
The cohort will be dichotomised in survival/non-survival groups according to the issue during ICU stay
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation of age between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Time Frame: from day 1 of admission
|
Variation of age between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
|
from day 1 of admission
|
Variation of medical history between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Time Frame: from day 1 of admission
|
Variation of medical history between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
|
from day 1 of admission
|
Variation of chronic drug used between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Time Frame: from day 1 of admission
|
Variation of chronic drug used between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
|
from day 1 of admission
|
Variation of chest CT scan at admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Time Frame: from day 1 of admission
|
Variation of chest CT scan at admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
|
from day 1 of admission
|
Variation of respiratory support at ICU admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
Time Frame: from day 1 of admission
|
Variation of respiratory support at ICU admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU
|
from day 1 of admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
July 1, 2020
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
April 6, 2020
First Submitted That Met QC Criteria
April 17, 2020
First Posted (Actual)
April 21, 2020
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2020_843_0026
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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