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

December 15, 2020 updated by: Sadia Taj, FMH College of Medicine and Dentistry
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • FMH college of medicine and dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

diagnosed cases of covid-19

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Covid-19 disease severity
Mild, moderate, severe and critical disease
Diagnostic test: not required
Diagnostic tests( hematological parameters) were assessed.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FMH College of Medicine and Dentistry

Investigators

  • Study Chair: Ayaz Lone, MBBS,FCPS, FMH college of medicine and dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 15, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMHCMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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