| CTRI Number |
CTRI/2023/01/049142 [Registered on: 23/01/2023] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Secondary analysis of published studies |
| Study Design |
Other |
|
Public Title of Study
|
Effect of vaccination in Covid-19 patients requring ICU admission |
|
Scientific Title of Study
|
To estimate the effect of Vaccination in critically ill COVID-19 patients, analysis using propensity matching. |
| 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 Ashok Havaldar |
| Designation |
Associate 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 Ashok Havaldar |
| Designation |
Associate 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 Ashok Havaldar |
| Designation |
Associate 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 Ashok Havaldar |
| Address |
Department of Critical Care medicine St Johns Hospital Bangalore
Bangalore
KARNATAKA
560034
India |
| 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 Ashok Havaldar |
St Johns Medical College |
Department of Critical
Care medicine St Johns
Hospital Bangalore
Bangalore
Bangalore
KARNATAKA |
9036082112
amarjahavaldar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC St Johns medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U071||COVID 19 virus identified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The non-vaccinated and vaccinated patients who developed covid-19 requiring ICU admission. |
|
| ExclusionCriteria |
| Details |
The patients admitted with the non-covid illness will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the effect of vaccination on the ICU mortality |
Condition at the time of ICU discharge alive or dead |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the duration of mechanical ventilation.
To study the ICU length of stay |
Till ICU discharge or Death |
|
|
Target Sample Size
|
Total Sample Size="841"
Sample Size from India="841"
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)
|
31/01/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a secondary analysis of the already published studies. The study is aimed to estimate the effect of vaccination on ICU mortaliy in patients who developed covid-19 illness. |