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

NCT04674553 | Completed

• 1 other identifier: 16021982
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Covid19

Keywords

obesity covid-19 assisted ventilation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• COVID-19 severity

  From date of randomization until the date of first documented symptom progression assessed up to 4weeks of study

• Oxygen requirement

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asian people having COVID-19 PCR positive

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Mehwish Iftikhar

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Obesity; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Mehwish Iftikhar, FCPS (Endo)

  SIMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Inevstigator

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 19, 2020
• Study Start: November 10, 2020
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

PA (1)