"Clinical Characteristics, Comorbidities and Outcome of Critically Sick Patients With COVID-19

"Clinical Characteristics, Comorbidities and Outcome of Critically Sick Patients With COVID-19 Pneumonia Admitted in Intensive Care Unit of a Tertiary Care Hospital in Lahore, Pakistan": A Retrospective Cohort Study

COVID-19, caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), is a multisystem disease which primarily involves the respiratory tract. The first case of COVID-19 was identified in late 2019 in the province of Wuhan, China which was followed by the rapid spread of the disease globally, becoming a present-day pandemic.

Objectives: The aim of this study was to describe the clinical characteristics, comorbidities and outcome of the critically sick patients with COVID-19 pneumonia admitted in ICU of a tertiary care hospital in Lahore.

Study Overview

• Status: Completed
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Combination product: Patients with COVID-19 Pneumonia

Detailed Description

Objectives: The aim of this study was to describe the clinical characteristics, comorbidities and outcome of the critically sick patients with COVID-19 pneumonia admitted in ICU of a tertiary care hospital in Lahore.

Material & Methods:

Study design: Retrospective study. Study Settings: Study was conducted in Fatima Memorial Hospital, Lahore. Study Duration: Study was conducted on Covid-19 patients who were admitted from March 2021 to August 2021.

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Fatima Memorial Hospital College of Medicine & Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Non-interventional retrospective cohort study of critically sick patients with COVID-19 pneumonia admitted in the Intensive Care Unit of Fatima Memorial hospital (FMH) in Lahore, Pakistan from March 2021 to August 2021 4.3. Sample Size & Technique: Records of 133 patients admitted to the ICU of the Fatima memorial hospital, Lahore, were studied.

Description

Inclusion Criteria:

• Critically sick patients with COVID-19 Pneumonia
• All admitted ICU patients with a diagnosis of COVID-19 pneumonia
• Patients having positive reverse transcriptase PCR for COVID-19
• Patients with High-resolution computed tomography (HRCT) chest findings suggestive of COVID-related lung injury
• All patients above 16 years of age with both genders( males and females)

Exclusion Criteria:

• All patients with PCR negative with mild symptoms
• Patients with No signs of COVID-19 pneumonia on HRCT chest

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with COVID-19 pneumonia; These patients were admitted in ICU for management of Covid-19 pneumonia usual care was offered to all patients	Combination product: Patients with COVID-19 Pneumonia; Patients were offered with usual care of COVID-19 in ICU and we did retrospective study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	The primary endpoint of the study will be to assess the ICU mortality (in percentages% and Numbers) of critically sick patients with COVID-19 pneumonia admitted to the intensive care unit	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comorbidities	we will assess various comorbidities in critically sick patients with COVID-19 pneumonia admitted to the intensive care unit	6 months

Collaborators and Investigators

• Sponsor: FMH College of Medicine and Dentistry
• Investigators: Principal Investigator: Aijaz Zeeshan K Chachar, MBBS,FCPS, FMH College of Medicine & Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Covid-19; Outcomes; Comorbidities
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: FMH-27/12/2021-IRB-983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All the record can be retrieved from medical record department of fatima memorial hospital Lahore
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No