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

NCT05249803 | Completed DMC FDA Drug FDA Device

• 1 other identifier: FMH-27/12/2021-IRB-983
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19 Pneumonia

Keywords

Comorbidities; Outcomes; Covid-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comorbidities

  6 months

Study Arms (1)

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

Interventions

Patients with COVID-19 Pneumonia COMBINATION_PRODUCT

Patients were offered with usual care of COVID-19 in ICU and we did retrospective study

Patients with COVID-19 pneumonia

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• FMH College of Medicine and Dentistry: lead

Study Sites (1)

Fatima Memorial Hospital College of Medicine & Dentistry

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

• Aijaz Zeeshan K Chachar, MBBS,FCPS

  FMH College of Medicine & Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician (Senior Registrar)

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 22, 2022
• Study Start: March 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

PA (1)