Role of Hematological Parameters in the Stratification of... | NCT04670328

Studies
Role of Hematological Parameters in the Stratification of COVID-19 Disease Severity

NCT04670328

Sponsor

FMH College of Medicine and Dentistry

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

101Actual

Phase

Not provided

Conditions

Covid19

Interventions

not required

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

Dec 2020

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

May 1, 2020Actual

Primary Completion Date

Jul 31, 2020Actual

Completion Date

Jul 31, 2020Actual

First Submitted Date

Dec 14, 2020

First Submission Date that Met QC Criteria

Dec 15, 2020

First Posted Date

Dec 17, 2020Actual

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

Dec 15, 2020

Last Update Posted Date

Dec 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sadia Taj, Assistant Professor, 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

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity.

Detailed Description

Objective:

COVID-19 virus involves respiratory as well as other body systems including cardiovascular, gastrointestinal, neurological, immunological and hematopoietic system. Patient of covid-19 pneumonia presents with wide range of hemostatic abnormalities. These hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity.

Material and Method:

This was a retrospective study, conducted in Department of Pathology and Department of medicine, FMH college of Medicine and Dentistry from May 2020 to July 2020. Total of 101, confirmed cases of covid-19 disease, both genders between 17 to 75-year age were included. Hematological parameters were compared in mild, moderate, severe and critical disease group. Continuous variables were analyzed by using non parametric, Kruskal Wallis test while categorical variables were analyzed by chi-square test.

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

Retention

Enrollment

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Covid-19 disease severity		Mild, moderate, severe and critical disease	Diagnostic Test: not required

Interventions

Name	Type	Description	Arm Group Labels	Other Names
not required	Diagnostic Test	Diagnostic tests( hematological parameters) were assessed.	Covid-19 disease severity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete blood count- Hemoglobin. White blood count, platelet count, Neutrophil to lymphocyte ratio	disease severity was assessed on basis of hematological parameters.	3 months

Secondary Outcomes

Measure	Description	Time Frame
PT, APTT and D-dimer	improvement in PT, APTT and D-dimer levels were assessed	3 months

Other Outcomes

Measure	Description	Time Frame
LDH, serum ferritin level	improvement in LDH and were assessed	3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosed cases of covid-19 disease
Both genders
17 to 75 year age

Exclusion Criteria:

known case of chronic liver disease
known hematological diseases were excluded

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

diagnosed cases of covid-19

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayaz Lone, MBBS,FCPS	FMH College of Medicine and Dentistry	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FMH college of medicine and dentistry		Lahore	Punjab Province	54000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

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Browse Branches

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