Association Between BMI and COVID-19

SARS-CoV 2 Clinical Trial

— BMI-SARS-CoV-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391738
• Other study ID #: DEC20-095
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: May 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: September 1, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV 2

Intervention

Other:
• Patients admitted to Intensive Care Unit with SARS-CoV2
Patients admitted to Intensive Care Unit with SARS-CoV2

Locations

Country	Name	City	State
France	Centre Hospitalier Régional & Universitaire de Lille (CHRU)	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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