| CTRI Number |
CTRI/2021/03/031663 [Registered on: 02/03/2021] Trial Registered Prospectively |
| Last Modified On: |
28/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Complete Blood Count as screening tool for COVID-19 |
|
Scientific Title of Study
|
White Blood Cell Scattergrams in COVID-19 patients – a rapid screening tool? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mustafa Ranapurwala |
| Designation |
Professor in pathology |
| Affiliation |
Pramukhswami Medical College, Bhaikaka University, Karamsad, GUJ,IN. |
| Address |
112,Hematology and Clinical Pathology section,
Central Diagnositc Centre, First Floor, Main Building, Shree Krishna Hospital,
Anand
GUJARAT
388325
India |
| Phone |
09898982709 |
| Fax |
|
| Email |
dr.mustafa.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mustafa Ranapurwala |
| Designation |
Professor in pathology |
| Affiliation |
Pramukhswami Medical College, Bhaikaka University, Karamsad, GUJ,IN. |
| Address |
112,Hematology and Clinical Pathology section,
Central Diagnositc Laboratory, First Floor, Main Building, Shree Krishna Hospital,
Anand
GUJARAT
388325
India |
| Phone |
09898982709 |
| Fax |
|
| Email |
dr.mustafa.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mustafa Ranapurwala |
| Designation |
Professor in pathology |
| Affiliation |
Pramukhswami Medical College, Bhaikaka University, Karamsad, GUJ,IN. |
| Address |
112,Hematology and Clinical Pathology section,
Central Diagnositc Centre, First Floor, Main Building, Shree Krishna Hospital,
Anand
GUJARAT
388325
India |
| Phone |
09898982709 |
| Fax |
|
| Email |
dr.mustafa.r@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pramukhswami Medical College |
| Address |
Pramukhswami Medical College and Shree Krishna Hospital,
Bhaikaka University,
Karamsad- 388325. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mustafa Fakaruddin Ranapurwala |
Hematology and Clinical Pathology Section |
Central Diagnostic Laboratory,
First Floor, Main Building
Shree Krishna Hospital, Gokalnagar, Karamsad - 388325
Anand
GUJARAT |
9898982709
dr.mustafa.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE – 2 H M PATEL CENTRE FOR MEDICAL CARE AND EDUCATION, KARAMSAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J100||Influenza due to other identifiedinfluenza virus with pneumonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
RAT and/or RT-PCR positive COVID – 19 patients in whom haemogram was ordered. |
|
| ExclusionCriteria |
| Details |
Suspected COVID – 19 patients, who tested negative with either RAT or RT- PCR.
COVID – 19 patients in whom haemogram was not ordered.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Specific pattern of sandglass pattern in COVID-19 patients |
at baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/03/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study is being undertaken to evaluate the utility of the specific pattern of WBC
scattergram as a screening tool for COVID-19 by establishing the sensitivity
and specificity of the
‘sandglass pattern’. No study has been published
so far from the Indian subcontinent. Hence, with the present study, we wish to study these graphic displays and whether
specific patterns are associated with COVID-19
infection. |