| CTRI Number |
CTRI/2023/07/055518 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
White blood cell parameters in COVID-19 infection |
|
Scientific Title of Study
|
White blood cell parameters in patients diagnosed with COVID-19 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Jain Gupta |
| Designation |
Senior specialist |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Pathology, Lok Nayak Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
9873617571 |
| Fax |
|
| Email |
drrashmijaingupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Jain Gupta |
| Designation |
Senior specialist |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Pathology, Lok Nayak Hospital, New Delhi
DELHI
110002
India |
| Phone |
9873617571 |
| Fax |
|
| Email |
drrashmijaingupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Jain Gupta |
| Designation |
Senior specialist |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Pathology, Lok Nayak Hospital, New Delhi
DELHI
110002
India |
| Phone |
9873617571 |
| Fax |
|
| Email |
drrashmijaingupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pathology, Lok Nayak Hospital, New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Rashmi Jain Gupta |
| Address |
Department of Pathology, Lok Nayak Hospital, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 Rashmi Jain Gupta |
Lok Nayak Hospital, New Delhi 110002 |
Laboratory 1, Room no. 109, Department of Pathology, Accident and emergency block, Lok Nayak Hospital, Jawaharlal Nehru Marg, New Delhi 110002
Central
DELHI |
9873617571
drrashmijaingupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and associated Lok Nayak hospital |
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
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted to Lok Nayak Hospital who were diagnosed with COVID-19 during the period of study from 15 April to 15 May 2021 and from 4 January to 4 February 2022 |
|
| ExclusionCriteria |
| Details |
Patients whose white blood cell count was extremely low and differential leucocyte count could not be done. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the white blood cell parameters total leucocyte count, percentage of neutrophils, lymphocytes, eosinophils & basophils of the patients admitted during the COVID wave in April May 2021 & during the COVID wave in January February 2022. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the white blood cell parameters of patients diagnosed with COVID-19 with the severity of COVID-19 infection |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
21/07/2023 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 a retrospective study where secondary data from previous laboratory records of patients infected with COVID-19 admitted at Lok Nayak Hospital will be analyzed. The patients admitted during the second COVID wave from 15 April to 15 May 2021 and those admitted during the third COVID wave from 4 January to 4 February 2022 will be included in the study. The patients will further be categorized as critically ill intensive care unit (ICU) patients or non-ICU patients. White blood cell parameters included from the automated hematology analyzer Mindray and Sysmex will be total leucocyte count, percentage of neutrophils, lymphocytes, eosinophils and basophils. Neutrophil lymphocyte ratio (NLR) and neutrophil monocyte ratio (NMR) will be calculated from the data collected. |