COVID-19 PandemicNCT05771857
Obesity: an Underappreciate Risk Factor for Severe Form of COVID-19
An observational study of COVID-19 Pandemic and Obesity, run by Mohammed VI University Hospital at 1 site in Morocco.
Trial summary
Our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic, Obesity
- What is being tested?
- Obesity
- Type of treatment
- Medical device
- How many people
- 415 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Mar 2020to 1 Oct 2021
- How long will I take part?
- 2 Years
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: investigators have included all the patients presenting an infection with SARS-CoV-2 (1069 patients) diagnosed following the regarding of the world health organization (WHO), confirmed by a PCR of a nasopharyngeal swap, or highly suspected images on thoracic CT scans, that were hospitalized in the intensive care unit.
Who may be able to join
- All patients presenting an infection with SARS-CoV-2 that were hospitalized in the intensive care unit.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obesity: an Underappreciate Risk Factor for Severe Form of COVID-19: Retrospective Cohort Study of 415 Cases
Our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19.
Read the detailed description
Introduction: COVID 19 pandemic continues to progress with a considerable mortality and morbidity throughout the world since its emergence in December 2019. Many studies were conducted to identify the predictive factors of mortality of those infected with the virus. The previous studies noticed that obesity seems to be associated with severe form of respiratory distress syndrome. Our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19.
Methods: investigators led a retrospective monocentric, descriptive and analytic study, in the department of anesthesia and intensive care unit of the university hospital of Mohamed VI Oujda, in Morocco, from March 2020 to October 2021, including all the patients tested positive for the infection.
- Conditions
- COVID-19 Pandemic, Obesity
- Being tested
- Obesity
- Medical subject headings
- COVID-19, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObesityDevice
the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity: An underappreciate risk factor for severe form of COVID-19: Retrospective cohort study of 415 cases
Is obesity a predictive factor of need of intensive care, in addition to the mortality of covid 19?
Measured: in all the 22 mounths
Risk factor for severe form of COVID-19
identify the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19.
Measured: in all the 22 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Mar 2020
- Primary completion30 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies 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
- Other
- Enrolment
- 415 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Mohammed VI University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younes Oujidi, Mohammed VI University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771857
- Sponsor's protocol ID
- Service anesthesie Reanimation
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Simonnet A, Chetboun M, Poissy J, Raverdy V, Noulette J, Duhamel A, Labreuche J, Mathieu D, Pattou F, Jourdain M; LICORN and the Lille COVID-19 and Obesity study group. High Prevalence of Obesity in Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Requiring Invasive Mechanical Ventilation. Obesity (Silver Spring). 2020 Jul;28(7):1195-1199. doi: 10.1002/oby.22831. Epub 2020 Jun 10.
PubMed 32271993Gao F, Zheng KI, Wang XB, Sun QF, Pan KH, Wang TY, Chen YP, Targher G, Byrne CD, George J, Zheng MH. Obesity Is a Risk Factor for Greater COVID-19 Severity. Diabetes Care. 2020 Jul;43(7):e72-e74. doi: 10.2337/dc20-0682. Epub 2020 May 14. No abstract available.
PubMed 32409499Yu W, Rohli KE, Yang S, Jia P. Impact of obesity on COVID-19 patients. J Diabetes Complications. 2021 Mar;35(3):107817. doi: 10.1016/j.jdiacomp.2020.107817. Epub 2020 Nov 26.
PubMed 33358523
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity: an Underappreciate Risk Factor for Severe Form of COVID-19: Retrospective Cohort Study of 415 Cases
- ClinicalTrials.gov ID
- NCT05771857
- Acronym / sponsor ID
- Service anesthesie Reanimation
- Conditions
- COVID-19 Pandemic, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Mohammed VI University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 16 Mar 2023 (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.
Our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19.
Detailed description
Introduction: COVID 19 pandemic continues to progress with a considerable mortality and morbidity throughout the world since its emergence in December 2019. Many studies were conducted to identify the predictive factors of mortality of those infected with the virus. The previous studies noticed that obesity seems to be associated with severe form of respiratory distress syndrome. Our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19.
Methods: investigators led a retrospective monocentric, descriptive and analytic study, in the department of anesthesia and intensive care unit of the university hospital of Mohamed VI Oujda, in Morocco, from March 2020 to October 2021, including all the patients tested positive for the infection.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- investigators have included all the patients presenting an infection with SARS-CoV-2 (1069 patients) diagnosed following the regarding of the world health organization (WHO), confirmed by a PCR of a nasopharyngeal swap, or highly suspected images on thoracic CT scans, that were hospitalized in the intensive care unit.
Key inclusion criteria (1 listed)
- All patients presenting an infection with SARS-CoV-2 that were hospitalized in the intensive care unit.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Obesitythe objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19 | Device | – |
Primary outcome
Obesity: An underappreciate risk factor for severe form of COVID-19: Retrospective cohort study of 415 cases
Time frame: in all the 22 mounths
Is obesity a predictive factor of need of intensive care, in addition to the mortality of covid 19?
Risk factor for severe form of COVID-19
Time frame: in all the 22 mounths
identify the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19.
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 Mar 2023.
- Background: PubMed 32271993Simonnet A, Chetboun M, Poissy J, Raverdy V, Noulette J, Duhamel A, Labreuche J, Mathieu D, Pattou F, Jourdain M; LICORN and the Lille COVID-19 and Obesity study group. High Prevalence of Obesity in Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Requiring Invasive Mechanical Ventilation. Obesity (Silver Spring). 2020 Jul;28(7):1195-1199. doi: 10.1002/oby.22831. Epub 2020 Jun 10.
- Background: PubMed 32409499Gao F, Zheng KI, Wang XB, Sun QF, Pan KH, Wang TY, Chen YP, Targher G, Byrne CD, George J, Zheng MH. Obesity Is a Risk Factor for Greater COVID-19 Severity. Diabetes Care. 2020 Jul;43(7):e72-e74. doi: 10.2337/dc20-0682. Epub 2020 May 14. No abstract available.
- Background: PubMed 33358523Yu W, Rohli KE, Yang S, Jia P. Impact of obesity on COVID-19 patients. J Diabetes Complications. 2021 Mar;35(3):107817. doi: 10.1016/j.jdiacomp.2020.107817. Epub 2020 Nov 26.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19 Pandemic
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Enrolling by invitationObservational study
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Dementia
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
Active, not recruiting
Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use
Liver Diseases, Alcohol Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
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-19 Pandemic and Obesity, run by Mohammed VI University Hospital at 1 site in Morocco.
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 1 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 Mar 2023. 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 Morocco. 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?
Obesity: An underappreciate risk factor for severe form of COVID-19: Retrospective cohort study of 415 cases (time frame: in all the 22 mounths). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05771857, which also lists 3 linked publications.
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 Mar 2023.