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

June 11, 2020 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54511
        • Centre hospitalo-universitaire régional de Nancy

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 admitted to ICUs of the University Hospital during the first Covid -19 wave in Nancy, Région Grand Est, France

Description

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

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU mortality
Time Frame: through study completion, an average of 14 days
number of fatal cases
through study completion, an average of 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive mechanical ventilation
Time Frame: through study completion, an average of 14 days
number of patients with invasive mechanical ventilation
through study completion, an average of 14 days
In-hospital mortality
Time Frame: through study completion, an average of 21 days
number of fatal cases
through study completion, an average of 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Olivier Ziegler, PU-PH, CHRU of Nancy

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)

May 12, 2020

Primary Completion (Actual)

May 25, 2020

Study Completion (Actual)

May 26, 2020

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI082

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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