COVIDCOV-OB-ICUNCT04425213
Obesity and Mortality of Critically Ill Patients With COVID-19
An observational study of COVID and Severe Acute Respiratory Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Disproportionate impact of COVID-19 in patients with obesity is now well established. Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Severe Acute Respiratory Syndrome, Obesity
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2020to 26 May 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: Critically ill patients admitted to ICUs of the University Hospital during the first Covid -19 wave in Nancy, Région Grand Est, France
Who may be able to join
- Adult patients with COVID-19 pneumonia admitted to ICUs between February 27th and April 18th 2020.
- Infection confirmed by reverse transcriptase polymerase chain reaction assay or radiologically by chest computed tomography scan
Who cannot join
- No weight or height measurement available in the medical files
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hospitalo-universitaire régional de Nancy
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Obesity as a Risk Factor for Mortality of Critically Ill Patients With Coronavirus Disease 2019 (COVID-19): a Cohort Study of the First Wave in Nancy, France
Disproportionate impact of COVID-19 in patients with obesity is now well established.
Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19.
The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.
Read the detailed description
The investigators aim to report ICU mortality for patients according to BMI category and to describe the detailed ICU clinical course of illness :
- Risk factors for ICU mortality : age, sex, baseline comorbidities
- Causes of death
- Risk factors for use of non invasive mechanical ventilation
- Non-fatal outcomes
- Ventilator-free days
- ICU length of stay.
- Conditions
- COVID, Severe Acute Respiratory Syndrome, Obesity, Comorbidities and Coexisting Conditions
- Keywords
- Mortality, Covid-19, Invasive mechanical ventilation, Obesity, Acute Respiratory Distress syndrome, Intensive Care Unit, Critically ill patient
- Medical subject headings
- Severe Acute Respiratory Syndrome, Obesity, COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | BMI < 25 kg/m2 | |
| Overweight | BMI : 25 - 29.9 kg/m2 | |
| Moderate obesity | BMI : 30 - 39.9 kg/m2 | |
| Severe obesity | BMI : > or = 40 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
number of fatal cases
Measured: through study completion, an average of 14 days
Secondary outcomes (2)
Invasive mechanical ventilation
number of patients with invasive mechanical ventilation
Measured: through study completion, an average of 14 days
In-hospital mortality
number of fatal cases
Measured: through study completion, an average of 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start12 May 2020
- Primary completion25 May 2020
- Study completion26 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Ziegler, PU-PH, Principal investigator, CHRU of Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425213
- Sponsor's protocol ID
- 2020PI082
- Acronym
- COV-OB-ICU
- Status last verified
- May 2020
- First submitted
- 28 May 2020
- Last updated
- 16 Jun 2020
- 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 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity as a Risk Factor for Mortality of Critically Ill Patients With Coronavirus Disease 2019 (COVID-19): a Cohort Study of the First Wave in Nancy, France
- ClinicalTrials.gov ID
- NCT04425213
- Acronym / sponsor ID
- COV-OB-ICU / 2020PI082
- Conditions
- COVID, Severe Acute Respiratory Syndrome, Obesity, Comorbidities and Coexisting Conditions
- Keywords
- Mortality, Covid-19, Invasive mechanical ventilation, Obesity, Acute Respiratory Distress syndrome, Intensive Care Unit, Critically ill patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 11 Jun 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.
Disproportionate impact of COVID-19 in patients with obesity is now well established.
Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19.
The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.
Detailed description
The investigators aim to report ICU mortality for patients according to BMI category and to describe the detailed ICU clinical course of illness :
- Risk factors for ICU mortality : age, sex, baseline comorbidities
- Causes of death
- Risk factors for use of non invasive mechanical ventilation
- Non-fatal outcomes
- Ventilator-free days
- ICU length of stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | –BMI < 25 kg/m2 |
| Overweight | – | –BMI : 25 - 29.9 kg/m2 |
| Moderate obesity | – | –BMI : 30 - 39.9 kg/m2 |
| Severe obesity | – | –BMI : > or = 40 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to ICUs of the University Hospital during the first Covid -19 wave in Nancy, Région Grand Est, France
Key inclusion criteria (2 listed)
- Adult patients with COVID-19 pneumonia admitted to ICUs between February 27th and April 18th 2020.
- Infection confirmed by reverse transcriptase polymerase chain reaction assay or radiologically by chest computed tomography scan
Key exclusion criteria (1 listed)
- No weight or height measurement available in the medical files
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU mortality
Time frame: through study completion, an average of 14 days
number of fatal cases
2 secondary outcomes
Invasive mechanical ventilation
Time frame: through study completion, an average of 14 days
In-hospital mortality
Time frame: through study completion, an average of 21 days
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 16 Jun 2020.
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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.
Olivier Ziegler, PU-PH principal investigator
CHRU of Nancy
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 COVID and Severe Acute Respiratory Syndrome, run by Central Hospital, Nancy, France 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 2 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 16 Jun 2020. 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?
ICU mortality (time frame: through study completion, an average of 14 days). 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 16 Jun 2020.