| CTRI Number |
CTRI/2020/07/026574 [Registered on: 14/07/2020] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the seriousness in COVID-19 patients with the blood test report.
|
|
Scientific Title of Study
|
Neutrophil-lymphocyte ratio and Platelet to lymphocyte ratio as markers for predicting the severity in COVID-19 patients: A Prospective Observational study.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yudhyavir Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS |
| Address |
Room No 322A JPNATC AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9811140057 |
| Fax |
|
| Email |
yudhyavir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yudhyavir Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS |
| Address |
Room No 322A JPNATC AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9811140057 |
| Fax |
|
| Email |
yudhyavir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yudhyavir Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS |
| Address |
Room No 322A JPNATC AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9811140057 |
| Fax |
|
| Email |
yudhyavir@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Hospital |
| Address |
DEPTT of Anaesthesia,
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Yudhyavi Singh |
COVID Centre,AIIMS, New Delhi |
Room No 322A
South
DELHI |
9811140057
yudhyavir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee |
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, (2) ICD-10 Condition: B349||Viral infection, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Only confirmed cases of COVID-19 diagnosed on the basis of ICMR standard |
|
| ExclusionCriteria |
| Details |
1.Age below 6 years.
2.Pregnant patients
3.Dialysis dependent patients
4.All trauma patients
5.Any malignancy
6.Any psychiatric illness
7.Consent not given
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the ability of the NLR and PLR to predict severity in COVID-19 patients.
|
Baseline-on admission
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mortality
2. Length of hospitalization
3. Mechanical ventilation
|
28 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Of note, a high incidence of lymphopenia in COVID-19 patients has been seen. In addition, the baseline neutrophil-to-lymphocyte ratio (NLR) has been confirmed as a potential prognostic indicator for patients in various other studies. So identifying severe patients in the early stage is of great significance for reducing the clinical morbidity and improving the cure rate. So, we aimed to compare peripheral blood neutrophil to lymphocyte count ratio (NLR) and platelet to lymphocyte ratio to explore the clinical indicator that can predict severity of COVID-19 in the early stage. Patients clinical symptoms and signs will be obtained from electronic medical records or files when the patient is admitted and receiving the treatment. All the relevant routine laboratory investigations will be noted from the electronic data records at the time of receiving the treatment. If required follow-up on telephone consultation will be done on the discharge. |