SARS-CoV 2BMI-SARS-CoV-2NCT04391738
Association Between BMI and COVID-19
An observational study of SARS-CoV 2, run by University Hospital, Lille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV 2
- What is being tested?
- Patients admitted to Intensive Care Unit with SARS-CoV2
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to Intensive Care Unit for SARS-CoV-2
Who may be able to join
- 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
Who cannot join
- -There are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Régional & Universitaire de Lille (CHRU)
Lille, 59100
About this study
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
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.
Read the 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)
- Conditions
- SARS-CoV 2
- Being tested
- Patients admitted to Intensive Care Unit with SARS-CoV2
- Keywords
- Intensive Care, Invasive Mechanical Ventilation, Body Mass Index, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients admitted to Intensive Care Unit with SARS-CoV2Other
Patients admitted to Intensive Care Unit with SARS-CoV2
| Study group | Role | What they receive |
|---|---|---|
| BMI SARS-CoV-2 | Patients admitted to Intensive Care Unit with SARS-CoV-2 Receives: Other: Patients admitted to Intensive Care Unit with SARS-CoV2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Feb 2020
- Primary completion15 May 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Pattou, MD, Study director, Centre Hospitalier Régional & Universitaire de Lille (CHRU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391738
- Sponsor's protocol ID
- DEC20-095
- Acronym
- BMI-SARS-CoV-2
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04391738
- Acronym / sponsor ID
- BMI-SARS-CoV-2 / DEC20-095
- Conditions
- SARS-CoV 2
- Keywords
- Intensive Care, Invasive Mechanical Ventilation, Body Mass Index, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMI SARS-CoV-2 | – | Other: Patients admitted to Intensive Care Unit with SARS-CoV2Patients admitted to Intensive Care Unit with SARS-CoV-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to Intensive Care Unit for SARS-CoV-2
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -There are no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients admitted to Intensive Care Unit with SARS-CoV2Patients admitted to Intensive Care Unit with SARS-CoV2 | Other | BMI SARS-CoV-2 |
Primary outcome
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 secondary outcomes
Associations between BMI and outcomes is independent of the known cardiometabolic risk factors
Time frame: 3 months
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: mortality
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Pattou, MD study director
Centre Hospitalier Régional & Universitaire de Lille (CHRU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV 2, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between body mass index (BMI) and SARS-CoV-2 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.