"Clinical Characteristics, Comorbidities and Outcome of C... | NCT05249803

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

NCT05249803

Sponsor

FMH College of Medicine and Dentistry

Status

Completed

Last Update Posted

Feb 22, 2022Actual

Enrollment

133Actual

Phase

Not provided

Conditions

COVID-19 Pneumonia

Interventions

Patients with COVID-19 Pneumonia

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Aug 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Feb 1, 2022

First Submission Date that Met QC Criteria

Feb 21, 2022

First Posted Date

Feb 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2022

Last Update Posted Date

Feb 22, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aijaz Zeeshan Khan Chachar, Consultant Physician (Senior Registrar), FMH College of Medicine and DentistryPrincipal Investigator

Lead Sponsor

FMH College of Medicine and DentistryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

133Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aijaz Zeeshan K Chachar, MBBS,FCPS	FMH College of Medicine & Dentistry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fatima Memorial Hospital College of Medicine & Dentistry		Lahore	Punjab Province	54000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All the record can be retrieved from medical record department of fatima memorial hospital Lahore

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Not provided

Access Criteria

Not provided

URL

http://www.fatimamemorial.org.pk

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided