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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Covid19

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Mehwish Iftikhar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Asian people having COVID-19 PCR positive

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Services Institute of Medical Sciences, Pakistan
• Investigators: Principal Investigator: Mehwish Iftikhar, FCPS (Endo), SIMS

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2020
• Primary Completion (ACTUAL): December 10, 2020
• Study Completion (ACTUAL): December 10, 2020

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (ACTUAL): December 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: obesity covid-19 assisted ventilation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; COVID-19; Obesity
• Other Study ID Numbers: 16021982

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No