Effect of Obesity Among COVID-19 Patients in Critical Care Settings

Obesity Clinical Trial

Official title:

Effect of Obesity Among COVID-19 Patients in Critical Care Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04674553
• Other study ID #: 16021982
• Status: Completed
• Start date: November 10, 2020
• Est. completion date: December 10, 2020

Study information

• Verified date: December 2020
• Source: Services Institute of Medical Sciences, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. All Patients presented to ICU with PCR positive for Covid-19 .

2. Both genders included.

3. Age range 18 to 80 years.

4. Patients fulfilling Criteria for moderate to severe disease.

5. Conscious patient on initial presentation.

6. BMI range from 18-> 40.

Exclusion Criteria:

1. Unable to provide free informed consent.

2. Pregnant females.

3. Gross ascites, amputation or other conditions making BMI measurement unreliable.

Related Conditions & MeSH terms

• Covid19
• Obesity

Locations

Country	Name	City	State
Pakistan	Mehwish Iftikhar	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Institute of Medical Sciences, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality	COVID-19 related mortality	From date of randomization until the date of death from any cause assessed up to 4weeks of study
Primary	Recovery from COVID-19	Negative PCR for COVID-19 and discharge from hospital	From date of randomization until recovery and discharge from hospital assessed up to 4weeks of study
Secondary	COVID-19 severity	Mild: Asymptomatic; Moderate:; Severe:; Critical: Any one of ARDS or MOF or septic shock	From date of randomization until the date of first documented symptom progression assessed up to 4weeks of study
Secondary	Oxygen requirement	Mild:SpO2 >94%; Moderate: SpO2<94%; Severe: SpO2<90% but > 80%; Critical: SpO2<80%	From date of randomization until date of first documented progression assessed up to 4weeks of study