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French Single Centre Experience of Critically Ill Patients With Covid 19 (CovidAmiens20)

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ClinicalTrials.gov Identifier: NCT04354558
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:
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

Condition or disease
Epidemiology Sars-CoV2 COVID 19 Critical Care Prognostic Survival

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology and Outcomes of Critically Ill Patients With Covid 19: a French Single Centre Experience
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021

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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Biospecimen Retention:   Samples Without DNA
alveolar liquid


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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
Critically ill patients with SARS Cov2 admitted in ICU
Criteria

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

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): NCT04354558


Contacts
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Contact: Osama Abou Arab, MD (33)3 22 08 78 36 abouarab.osama@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Osama Abou Arab, MD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04354558    
Other Study ID Numbers: PI2020_843_0026
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 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, Amiens:
Epidemiology
Sars-CoV2
COVID 19
critical care
prognostic
survival
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes