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Obesity and Mortality of Critically Ill Patients With COVID-19 (COV-OB-ICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04425213
Recruitment Status : Completed
First Posted : June 11, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Tracking Information
First Submitted Date May 28, 2020
First Posted Date June 11, 2020
Last Update Posted Date June 16, 2020
Actual Study Start Date May 12, 2020
Actual Primary Completion Date May 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2020)
ICU mortality [ Time Frame: through study completion, an average of 14 days ]
number of fatal cases
Original Primary Outcome Measures
 (submitted: June 9, 2020)
  • ICU mortality [ Time Frame: through study completion, an average of 14 days ]
    number of fatal cases
  • In-hospital mortality [ Time Frame: through study completion, an average of 21 days ]
    number of fatal cases
Change History
Current Secondary Outcome Measures
 (submitted: June 11, 2020)
  • Invasive mechanical ventilation [ Time Frame: through study completion, an average of 14 days ]
    number of patients with invasive mechanical ventilation
  • In-hospital mortality [ Time Frame: through study completion, an average of 21 days ]
    number of fatal cases
Original Secondary Outcome Measures
 (submitted: June 9, 2020)
Invasive mechanical ventilation [ Time Frame: through study completion, an average of 14 days ]
number of patients with invasive mechanical ventilation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Obesity and Mortality of Critically Ill Patients With COVID-19
Official Title Obesity as a Risk Factor for Mortality of Critically Ill Patients With Coronavirus Disease 2019 (COVID-19): a Cohort Study of the First Wave in Nancy, France
Brief Summary

Disproportionate impact of COVID-19 in patients with obesity is now well established.

Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19.

The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.

Detailed Description

The investigators aim to report ICU mortality for patients according to BMI category and to describe the detailed ICU clinical course of illness :

  • Risk factors for ICU mortality : age, sex, baseline comorbidities
  • Causes of death
  • Risk factors for use of non invasive mechanical ventilation
  • Non-fatal outcomes
  • Ventilator-free days
  • ICU length of stay.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Critically ill patients admitted to ICUs of the University Hospital during the first Covid -19 wave in Nancy, Région Grand Est, France
Condition
  • COVID
  • Severe Acute Respiratory Syndrome
  • Obesity
  • Comorbidities and Coexisting Conditions
Intervention Not Provided
Study Groups/Cohorts
  • Normal weight
    BMI < 25 kg/m2
  • Overweight
    BMI : 25 - 29.9 kg/m2
  • Moderate obesity
    BMI : 30 - 39.9 kg/m2
  • Severe obesity
    BMI : > or = 40 kg/m2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 9, 2020)
250
Original Actual Enrollment Same as current
Actual Study Completion Date May 26, 2020
Actual Primary Completion Date May 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients with COVID-19 pneumonia admitted to ICUs between February 27th and April 18th 2020.
  • Infection confirmed by reverse transcriptase polymerase chain reaction assay or radiologically by chest computed tomography scan

Exclusion Criteria:

  • No weight or height measurement available in the medical files
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04425213
Other Study ID Numbers 2020PI082
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Central Hospital, Nancy, France
Study Sponsor Central Hospital, Nancy, France
Collaborators Not Provided
Investigators
Principal Investigator: Olivier Ziegler, PU-PH CHRU of Nancy
PRS Account Central Hospital, Nancy, France
Verification Date May 2020