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.

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Key information

Conditions

Obesity Body Weight COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mehwish Iftikhar

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Unable to provide free informed consent.
Pregnant females.
Gross ascites, amputation or other conditions making BMI measurement unreliable.

Treatment and study plan

Primary outcomes

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

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

Mild: Asymptomatic; Moderate:; Severe:; Critical: Any one of ARDS or MOF or septic shock
Oxygen requirement

Time frame: From date of randomization until date of first documented progression assessed up to 4weeks of study

Mild:SpO2 >94%; Moderate: SpO2<94%; Severe: SpO2<90% but > 80%; Critical: SpO2<80%

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Dec 19, 2020
Registry last updated: Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed