Clinical trial NCT04391738: Association Between BMI and COVID-19
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV 2
Keywords: Intensive Care
Invasive Mechanical Ventilation
Body Mass Index
Obesity
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to Intensive Care Unit for SARS-CoV-2

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)

Eligibility criteria: 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

Primary outcomes:
measure: Relationship between body mass index (BMI) and SARS-CoV-2
timeFrame: 3 months
Secondary outcomes:
measure: Associations between BMI and outcomes is independent of the known cardiometabolic risk factors
timeFrame: 3 months
measure: Investigate the modifying effects of age and sex on the associations between BMI and outcome: Invasive mechanical ventilation
timeFrame: 3 months
measure: Investigate the modifying effects of age and sex on the associations between BMI and outcome: mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Hospitalier Régional & Universitaire de Lille (CHRU)
Study officials:
affiliation: Centre Hospitalier Régional & Universitaire de Lille (CHRU)
name: Francois Pattou, MD
role: STUDY_DIRECTOR
References: