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

• ClinicalTrials.gov Identifier: NCT04425213
• Recruitment Status: Completed
• First Posted: June 11, 2020
• Last Update Posted: June 16, 2020
• Sponsor: Central Hospital, Nancy, France
• 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

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

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

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