Association Between BMI and COVID-19 (BMI-SARS-CoV-2)

Relationship Between Obesity and Severe Acute Respiratory Syndrome Coronavirus-2 in Patient With SARS-CoV-2 Admitted in Intensive Care : A Multicenter Retrospective Cohort Study

This study will involve collection of pseudonymized data from hospital-based data reporting at multiple international sites. Collating data from a large volume of patients with COVID-19 admitted in ICU across multiple international sites will enable investigation of whether obesity is a risk factor for complicated from of SARS-CoV-2 in adult patients and whether this association is independent of other cardiometabolic risk factors.

Study Overview

• Status: Completed
• Conditions: SARS-CoV 2
• Intervention / Treatment: Other: Patients admitted to Intensive Care Unit with SARS-CoV2

Detailed Description

The COVID-19 pandemic is characterized by a high frequency of patients with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), who often require invasive mechanical ventilation (IMV). Body mass index (BMI) was however rarely mentioned in early clinical reports.

Disease severity gradually increased with body mass index (BMI) categories among patients admitted in intensive care unit (ICU) for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the need for invasive mechanical ventilation (IMV), reaching 85% in patients with class II or III obesity ( BMI > 35 kg/m2).

In summary, there is an urgent need for more evidence on the specific role played by obesity in the development of COVID-19 complications, and more particularly of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• France
  • Lille, France, 59100
    • Centre Hospitalier Régional & Universitaire de Lille (CHRU)

Participation Criteria

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

Adult patients admitted to Intensive Care Unit for SARS-CoV-2

Description

Inclusion Criteria:

• Participant is aged 18 years or over
• Has been admitted to ICU with COVID-19 disease.
• COVID-19 disease has been confirmed by PCR for SARS-CoV-2
• Height and weight or BMI on admission has been recorded
• Data has been collected in an ethical manner as part of a national database or clinical auditing process approved by the local institution or collaboration

Exclusion Criteria:

-There are no exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BMI SARS-CoV-2; Patients admitted to Intensive Care Unit with SARS-CoV-2	Other: Patients admitted to Intensive Care Unit with SARS-CoV2; Patients admitted to Intensive Care Unit with SARS-CoV2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between body mass index (BMI) and SARS-CoV-2	The primary objective of this study is to investigate the relationship between obesity, as determined by body mass index (BMI), and severe pneumonia, as defined by the need of invasive mechanical ventilation ( IMV), among patient admitted in ICU for SARS-CoV-2, across multiple centers, in multiple countries.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associations between BMI and outcomes is independent of the known cardiometabolic risk factors	Investigate whether the associations between BMI and outcomes is independent of the known cardiometabolic risk factors, hypertension, diabetes, dyslipidemia, and current smoking.	3 months
Investigate the modifying effects of age and sex on the associations between BMI and outcome: Invasive mechanical ventilation	Investigate the modifying effects of age and sex on the associations between BMI and outcome: Invasive mechanical ventilation	3 months
Investigate the modifying effects of age and sex on the associations between BMI and outcome: mortality	Investigate the modifying effects of age and sex on the associations between BMI and outcome: mortality	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Study Director: Francois Pattou, MD, Centre Hospitalier Régional & Universitaire de Lille (CHRU)

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Body Mass Index; Intensive Care; Invasive Mechanical Ventilation
• Other Study ID Numbers: DEC20-095

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No