ObesityNCT04674553
Effect of Obesity Among COVID-19 Patients in Critical Care Settings
An observational study of Obesity and Covid19, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial summary
A novel human coronavirus that is now named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (formerly called HCoV-19) emerged in Wuhan, China, in late 2019 and is now causing a pandemic. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Nov 2020to 10 Dec 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Asian people having COVID-19 PCR positive
Who may be able to join
- All Patients presented to ICU with PCR positive for Covid-19 .
- Both genders included.
- Age range 18 to 80 years.
- Patients fulfilling Criteria for moderate to severe disease.
- Conscious patient on initial presentation.
- BMI range from 18-> 40.
Who cannot join
- Unable to provide free informed consent.
- Pregnant females.
- Gross ascites, amputation or other conditions making BMI measurement unreliable.
Trial locations and contacts
1 site in 1 country.
About this study
A novel human coronavirus that is now named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (formerly called HCoV-19) emerged in Wuhan, China, in late 2019 and is now causing a pandemic. Human-to-human transmission is primarily achieved through close contact of respiratory droplets, direct contact with the infected individuals, or by contact with contaminated objects and surfaces. As a new chapter in human life opens up, the world seems to be divided into two parts pre- and post-COVID-19 era. Body mass index (BMI) is widely used to define obesity and overweight in adults. A BMI between 25 and 30 indicates overweight and above 30 indicates obesity. It is important to note that the levels of the inflammatory cytokines found in obese people are significantly higher than those in lean people, but they are still lower than those in individuals with infection or trauma. Obesity-mediated alterations in the airways and immune system are extremely important at the present moment considering SARS-Cov-2 infection. This study is designed to determine the effect of overweight and obesity with outcomes of patients with moderate to severe COVID-19 infection in critical care setting. Also, to see outcomes of assisted ventilation in obese patients.
This may help in establishing strong association of obesity with COVID-19 in our part of the world. This may open new treatment strategies for COVID-19 by treating obesity as an essential risk factor.
Read the detailed description
This Prospective Cohort Study study will be conducted in COVID-19 Intensive care unit, Services hospital Lahore. it will be completed in 3 months after approval of proposal taking 100 patients using Non Probability Purposive sampling.
After ethical approval, research will be started and patients will be recruited from ICU according to inclusion and exclusion criteria. Patients will be randomized to two groups Group A with normal BMI and Group B having over weight and obese patients. They will be given standard treatment as practiced and outcome will be measured in terms of recovery from disease or death. Duration of stay in hospital, progression of disease, O2 requirement, improvement in biochemical profile and radiology or occurrence of complications.
Data will be put in SPSS version 25 and analysis will be done.
- Keywords
- obesity covid-19 assisted ventilation
- Medical subject headings
- Obesity, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
COVID-19 related mortality
Measured: From date of randomization until the date of death from any cause assessed up to 4weeks of study
Recovery from COVID-19
Negative PCR for COVID-19 and discharge from hospital
Measured: From date of randomization until recovery and discharge from hospital assessed up to 4weeks of study
Secondary outcomes (2)
COVID-19 severity
Mild: Asymptomatic; Moderate:; Severe:; Critical: Any one of ARDS or MOF or septic shock
Measured: From date of randomization until the date of first documented symptom progression assessed up to 4weeks of study
Oxygen requirement
Mild:SpO2 >94%; Moderate: SpO2<94%; Severe: SpO2<90% but > 80%; Critical: SpO2<80%
Measured: From date of randomization until date of first documented progression assessed up to 4weeks of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start10 Nov 2020
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehwish Iftikhar, Services Institute of Medical Sciences, Pakistan
- Investigators
- Mehwish Iftikhar, FCPS (Endo), Principal investigator, SIMS SIUT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674553
- Sponsor's protocol ID
- 16021982
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Obesity Among COVID-19 Patients in Critical Care Settings
- ClinicalTrials.gov ID
- NCT04674553
- Acronym / sponsor ID
- 16021982
- Keywords
- obesity covid-19 assisted ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 19 Dec 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.
A novel human coronavirus that is now named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (formerly called HCoV-19) emerged in Wuhan, China, in late 2019 and is now causing a pandemic. Human-to-human transmission is primarily achieved through close contact of respiratory droplets, direct contact with the infected individuals, or by contact with contaminated objects and surfaces. As a new chapter in human life opens up, the world seems to be divided into two parts pre- and post-COVID-19 era. Body mass index (BMI) is widely used to define obesity and overweight in adults. A BMI between 25 and 30 indicates overweight and above 30 indicates obesity. It is important to note that the levels of the inflammatory cytokines found in obese people are significantly higher than those in lean people, but they are still lower than those in individuals with infection or trauma. Obesity-mediated alterations in the airways and immune system are extremely important at the present moment considering SARS-Cov-2 infection. This study is designed to determine the effect of overweight and obesity with outcomes of patients with moderate to severe COVID-19 infection in critical care setting. Also, to see outcomes of assisted ventilation in obese patients.
This may help in establishing strong association of obesity with COVID-19 in our part of the world. This may open new treatment strategies for COVID-19 by treating obesity as an essential risk factor.
Detailed description
This Prospective Cohort Study study will be conducted in COVID-19 Intensive care unit, Services hospital Lahore. it will be completed in 3 months after approval of proposal taking 100 patients using Non Probability Purposive sampling.
After ethical approval, research will be started and patients will be recruited from ICU according to inclusion and exclusion criteria. Patients will be randomized to two groups Group A with normal BMI and Group B having over weight and obese patients. They will be given standard treatment as practiced and outcome will be measured in terms of recovery from disease or death. Duration of stay in hospital, progression of disease, O2 requirement, improvement in biochemical profile and radiology or occurrence of complications.
Data will be put in SPSS version 25 and analysis will be done.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Asian people having COVID-19 PCR positive
Key inclusion criteria (6 listed)
- All Patients presented to ICU with PCR positive for Covid-19 .
- Both genders included.
- Age range 18 to 80 years.
- Patients fulfilling Criteria for moderate to severe disease.
- Conscious patient on initial presentation.
Key exclusion criteria (3 listed)
- Unable to provide free informed consent.
- Pregnant females.
- Gross ascites, amputation or other conditions making BMI measurement unreliable.
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
In-hospital mortality
Time frame: From date of randomization until the date of death from any cause assessed up to 4weeks of study
COVID-19 related mortality
Recovery from COVID-19
Time frame: From date of randomization until recovery and discharge from hospital assessed up to 4weeks of study
Negative PCR for COVID-19 and discharge from hospital
2 secondary outcomes
COVID-19 severity
Time frame: From date of randomization until the date of first documented symptom progression assessed up to 4weeks of study
Oxygen requirement
Time frame: From date of randomization until date of first documented progression assessed up to 4weeks of study
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 19 Dec 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.
Mehwish Iftikhar, FCPS (Endo) principal investigator
SIMS SIUT
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 Obesity and Covid19, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
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 6 inclusion and 3 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 19 Dec 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 Pakistan. 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?
In-hospital mortality (time frame: From date of randomization until the date of death from any cause assessed up to 4weeks of study). 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?
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 19 Dec 2020.