Association Between BMI and COVID-19

Completed

• Conditions: SARS-CoV 2
• Interventions: Other: Patients admitted to Intensive Care Unit with SARS-CoV2

• Registration Number: NCT04391738
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

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 Timeline

• Study Start: 2020-02-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Primary Completion: 2020-05-15
• Study First Posted: 2020-05-18
• Study Completion: 2020-09-01
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BMI SARS-CoV-2	Patients admitted to Intensive Care Unit with SARS-CoV2	Patients admitted to Intensive Care Unit with SARS-CoV-2

Primary Outcome Measures

Name	Time	Method
Relationship between body mass index (BMI) and SARS-CoV-2	3 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Régional & Universitaire de Lille (CHRU); 🇫🇷 Lille, France