| CTRI Number |
CTRI/2020/10/028436 [Registered on: 16/10/2020] Trial Registered Prospectively |
| Last Modified On: |
05/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
This study is designed to look at certain blood parameters like biomarkers for predicting the outcome of COVID patients |
|
Scientific Title of Study
|
Role of Biomarkers and it’s trend to predict the outcome of COVID patients, retrospective review |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amarja Havaldar |
| Designation |
Assistant Professor |
| Affiliation |
St Johns Medical college |
| Address |
Department of Critical care medicine St Johns Hospital Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9036082112 |
| Fax |
|
| Email |
amarjahavaldar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarja Havaldar |
| Designation |
Assistant Professor |
| Affiliation |
St Johns Medical college |
| Address |
Department of Critical care medicine St Johns Hospital Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9036082112 |
| Fax |
|
| Email |
amarjahavaldar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amarja Havaldar |
| Designation |
Assistant Professor |
| Affiliation |
St Johns Medical college |
| Address |
Department of Critical care medicine St Johns Hospital Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9036082112 |
| Fax |
|
| Email |
amarjahavaldar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Amarja Havaldar |
| Address |
Department of Critical care |
| 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 Amarja Havaldar |
St Johns Medical college |
Department of Critical Care medicine St Johns Hospital Bangalore
KARNATAKA Bangalore KARNATAKA
Bangalore
KARNATAKA |
9036082112
amarjahavaldar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Johns Medical college IEC |
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 |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with COVID 19 pneumonia admitted in ICU |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the trend of biomarkers and it’s effect on outcome (ICU mortality)in patients admitted with the diagnosis of COVID pneumonia. |
ICU mortality or at the end of 4 weeks
Hospital mortality or at the end of 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the number of ventilator free days
2. To study the difference in ICU length of stay
|
ICU mortality or at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
25/10/2020 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Use of
various biomarkers is being investigated and proposed biomarkers are C reactive
protein CRP, LDH, D Dimer, Ferritin, Troponin I , Procalcitonin and IL 6. Use
of these various biomarkers has been studied widely and can be suggested to be
used for prognostication. The simple biomarker such as Neutrophil/ Lymphocyte
ratio also can help in predicting outcome.
The aim of our study is to evaluate
the trend of various biomarkers done for these patients and can it be used to
predict the outcome of COVID 19 patients. |