Obesity Clinical Trial - Effect of Obesity Among COVID-19 Patients in

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04674553
Study type	Observational
Source	Services Institute of Medical Sciences, Pakistan
Contact
Status	Completed
Phase
Start date	November 10, 2020
Completion date	December 10, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms