Skip to main content
OpenTrials
Completed

NCT Number: NCT04391738

Association Between BMI and COVID-19

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

SARS-CoV 2 Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Régional & Universitaire de Lille (CHRU)

Lille, 59100, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients admitted to Intensive Care Unit with SARS-CoV2

Other

Patients admitted to Intensive Care Unit with SARS-CoV2

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: BMI-SARS-CoV-2

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 18, 2020
Registry last updated
Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.