NCT04391738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 26, 2021

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

May 14, 2020

Last Update Submit

March 25, 2021

Conditions

Keywords

Intensive CareInvasive Mechanical VentilationBody Mass IndexObesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Associations between BMI and outcomes is independent of the known cardiometabolic risk factors

    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

    3 months

Study Arms (1)

BMI SARS-CoV-2

Patients admitted to Intensive Care Unit with SARS-CoV-2

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

Interventions

Patients admitted to Intensive Care Unit with SARS-CoV2

BMI SARS-CoV-2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to Intensive Care Unit for SARS-CoV-2

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional & Universitaire de Lille (CHRU)

Lille, 59100, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Francois Pattou, MD

    Centre Hospitalier Régional & Universitaire de Lille (CHRU)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 18, 2020

Study Start

February 1, 2020

Primary Completion

May 15, 2020

Study Completion

September 1, 2020

Last Updated

March 26, 2021

Record last verified: 2020-05

Locations