| CTRI Number |
CTRI/2021/01/030789 [Registered on: 27/01/2021] Trial Registered Prospectively |
| Last Modified On: |
26/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of different complete blood count(CBC) parameters in prognosis of COVID -19 patients |
|
Scientific Title of Study
|
Evaluation of Hematological parameters as prognostic indicators in COVID -19 patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarojini Raman |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Medical Sciences,Bhubaneswar |
| Address |
Department Of Pathology,
KIMS,Campus-5
KIIT University
BBSR
Khordha
ORISSA
751024
India |
| Phone |
7077288117 |
| Fax |
|
| Email |
sarojini.raman@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarojini Raman |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Medical Sciences,Bhubaneswar |
| Address |
Department Of Pathology,
KIMS,Campus-5
KIIT University
BBSR
Khordha
ORISSA
751024
India |
| Phone |
7077288117 |
| Fax |
|
| Email |
sarojini.raman@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sarojini Raman |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Medical Sciences,Bhubaneswar |
| Address |
Department Of Pathology,
KIMS,Campus-5
KIIT University
BBSR
Khordha
ORISSA
751024
India |
| Phone |
7077288117 |
| Fax |
|
| Email |
sarojini.raman@kims.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KIMS Hospital |
| Address |
KIMS CAMPUS-5
PATIA,BBSR
ODISHA,INDIA |
| 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 SAROJINI RAMAN |
ODISHA COVID HOSPITAL,KIMS |
Ground Floor,First and Third Floor:A,B
Second Floor:ICU,HDU
CAMPUS-5,
KIIT CAMPUS,PATIA,BBSR
Khordha
ORISSA |
7077288117
sarojini.raman@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE KIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)ALL RT-PCR POSITIVE COVID-19 PATIENTS |
|
| ExclusionCriteria |
| Details |
1)All COVID unrelated cases .
2)Patients in which proper clinical details missing |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| These parameters are expected to act as indicators of immune status of patient, hyperinflammatory and cytokine storm status, indicators of superinfection , disease severity and extent of systemic inflammation |
The parameters will be assessed at the time of admission and at the time of discharge in case of general ward patients and at 1 week interval in case of ICU patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FEW DERIVED HEMATOLOGICAL PARAMETERS CAN ACT AS INDICTORS OF POOR PROGNOSIS IN COVID 19 PATIENTS |
Parameters will be assessed at the time of discharge in general ward patients and at 1 week interval in ICU patients |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
29/01/2021 |
| 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="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study aims to assess the role of hematological parameters ,both direct and derived, in predicting the severity of COVID 19 patients.The parameters like absolute lymphocyte count,total leukocyte count,absolute neutrophil count, neutrophil lymphocyte ratio,platelet lymphocyte ratio,RDW to total platelet count ratio,mean platelet volume etc will be evaluated in predicting the severity of disease requiring early intervention in COVID 19 patients.These parameters will be correlated with other biochemical and clinical parameters also. The results obtained in the study will be published in appropriate journals. |