NCT04670328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

December 14, 2020

Last Update Submit

December 15, 2020

Conditions

Covid19

Keywords

Covid-19 diseaseNeutrophil to Lymphocyte ratiohematological manifestations

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • PT, APTT and D-dimer

    3 months

Other Outcomes (1)

  • LDH, serum ferritin level

    3 months

Study Arms (1)

Covid-19 disease severity

Mild, moderate, severe and critical disease

Diagnostic Test: not required

Interventions

not requiredDIAGNOSTIC_TEST

Diagnostic tests( hematological parameters) were assessed.

Covid-19 disease severity

Eligibility Criteria

Age17 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

diagnosed cases of covid-19

You may qualify if:

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

You may not qualify if:

  • known case of chronic liver disease
  • known hematological diseases were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FMH college of medicine and dentistry

Lahore, Punjab Province, 54000, Pakistan

Location

Biospecimen

Retention: NONE RETAINED

blood test

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ayaz Lone, MBBS,FCPS

    FMH College of Medicine and Dentistry

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 17, 2020

Study Start

May 1, 2020

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

No plan to share IPD

Locations

PA(1)