Association Between BMI and COVID-19 (BMI-SARS-CoV-2)
March 25, 2021 updated by: University Hospital, Lille
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Lille, France, 59100
- Centre Hospitalier Régional & Universitaire de Lille (CHRU)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
BMI SARS-CoV-2
Patients admitted to Intensive Care Unit with SARS-CoV-2
|
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
Time Frame: 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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Associations between BMI and outcomes is independent of the known cardiometabolic risk factors
Time Frame: 3 months
|
Investigate whether the associations between BMI and outcomes is independent of the known cardiometabolic risk factors, hypertension, diabetes, dyslipidemia, and current smoking.
|
3 months
|
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Investigate the modifying effects of age and sex on the associations between BMI and outcome: Invasive mechanical ventilation
Time Frame: 3 months
|
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
Time Frame: 3 months
|
Investigate the modifying effects of age and sex on the associations between BMI and outcome: mortality
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Francois Pattou, MD, Centre Hospitalier Régional & Universitaire de Lille (CHRU)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.