Obesity and Mortality of Critically Ill Patients With COVID-19

NCT04425213 | Completed DMC

• 1 other identifier: 2020PI082
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Severe Acute Respiratory Syndrome; Obesity; Comorbidities and Coexisting Conditions

Keywords

Mortality; Covid-19; Invasive mechanical ventilation; Obesity; Acute Respiratory Distress syndrome; Intensive Care Unit; Critically ill patient

Outcome Measures

Primary Outcomes (1)

• ICU mortality

  number of fatal cases

  through study completion, an average of 14 days

Secondary Outcomes (2)

• Invasive mechanical ventilation

  through study completion, an average of 14 days

• In-hospital mortality

  through study completion, an average of 21 days

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• No weight or height measurement available in the medical files

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre hospitalo-universitaire régional de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Obesity; COVID-19; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Lung Diseases; Respiration Disorders

Study Officials

• Olivier Ziegler, PU-PH

  CHRU of Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 11, 2020
• Study Start: May 12, 2020
• Primary Completion: May 25, 2020
• Study Completion: May 26, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-05

Locations

FR (1)