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CTRI Number  CTRI/2021/07/034587 [Registered on: 05/07/2021] Trial Registered Prospectively
Last Modified On: 29/06/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Admission of patients to intensive care unit after vaccination for covid or noncovid illenss and to study their clinical charactristics  
Scientific Title of Study   : To study the demographics and clinical characteristics of patients requiring Intensive care admission post COVID vaccination for COVID or Non Covid illnesses and their outcome, A Multicentre study,(PostCoVac Study) Retrospective Design 
Trial Acronym  PostCOVac Study 
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  Assistant Professor 
Affiliation  St Johns Medical college 
Address  Department of Critical Care medicine St Johns Hospital Bangalore KARNATAKA

Bangalore
KARNATAKA
560034
India 
Phone  9036082112  
Fax    
Email  amarjahavaldar@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amarja Ashok Havaldar 
Designation  Assistant Professor 
Affiliation  St Johns Medical college 
Address  Department of Critical Care medicine St Johns Hospital Bangalore KARNATAKA

Bangalore
KARNATAKA
560034
India 
Phone  9036082112  
Fax    
Email  amarjahavaldar@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amarja Ashok Havaldar 
Designation  Assistant Professor 
Affiliation  St Johns Medical college 
Address  Department of Critical Care medicine St Johns Hospital Bangalore KARNATAKA

Bangalore
KARNATAKA
560034
India 
Phone  9036082112  
Fax    
Email  amarjahavaldar@rediffmail.com  
 
Source of Monetary or Material Support  
IGIMS Patna 
RIMS Ranchi 
St Johns Medical college, Bangalore 
Yashoda Hospital ,Hyderabad 
 
Primary Sponsor  
Name  Dr Amarja Ashok Havaldar  
Address  Department of Critical Care medicine, St Johns Hospital Bangalore KARNATAKA  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjeev  IGIMS  Department of Critical care medicine
Patna
BIHAR 		 9473191829

sanjeev_pranay71@hotmail.com 
Dr Abhilash Chennabasappa  JSS Medical college Hospital  Department of Anaesthesia and Critical care
Mysore
KARNATAKA 		 9741804075

abhilashc91@gmail.com 
Dr Jayaprakash  RIMS Ranchi  Department of Critical care medicine
Ranchi
JHARKHAND 		 8084715507

dr.jay_prakash@rediffmail.com 
Dr Amarja Ashok Havaldar  St Johns Medical college  Department of Critical Care medicine
Bangalore
KARNATAKA 		 9036082112

amarjahavaldar@rediffmail.com 
Dr Kaladhar S  Yashoda Hospital  Department of Critical care
Hyderabad
TELANGANA 		 9553396000

kaladhar_sheshala@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
IGIMS Patna  Approved 
JSS Medical College  Approved 
RIMS Ranchi  Approved 
St Johns Medical college  Approved 
Yashoda Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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: I00-I99||Diseases of the circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patient’s admitted in ICU post vaccination either after first or second dose of vaccine will be included. 
 
ExclusionCriteria 
Details  Patients who have not taken the vaccine will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Broadly dividing patients into two groups. COVID or nonCovid illness.
1. Covid illness To evaluate the severity of Covid infection of patients admitted post vaccination and the effect on ICU mortality.
2. Noncovid illness – To identify what type of nonCovid illnesses patients developed post vaccination requiring Intensive care admission.and also to look for any thromboembolic phenomenon. And its effect on ICU mortality.

 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Number of ventilator free days
ICU length of stay
Hospital Mortality  		 Hospital discharge or hospital mortality at 90 days whichever is the earliest 
 
Target Sample Size   Total Sample Size="770"
Sample Size from India="770" 
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)   10/07/2021 
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
Modification(s)  		 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   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 study of patients getting admitted to Intensive care unit post vaccination due to COVID or non Covid illness and to study their characteristics, severity of illness and outcome
The purpose of study is to look for any particular cause for ICU admission, and if patients get COVID inspite of Vaccination to check for the severity of infection

 
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