PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 19:25:07 GMT)

CTRI Number CTRI/2021/03/031685 [Registered on: 03/03/2021] - Trial Registered Prospectively Last Modified On 03/03/2021 Post Graduate Thesis No Type of Trial Observational Type of Study Cross Sectional Study Study Design Other Public Title of Study “COVID-19 vaccination: The dilemma faced by a Health care worker. Scientific Title of “COVID-19 vaccination: The continuing dilemma of a health care worker” Study Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Pragyan S Panda Trial Coordinator (multi-center study) Designation Assistant Professor Affiliation Janakpuri Super Speciality Hospital Society Address Janakpuri Super Speciality Hospital Society. Department of Microbiology 1st floor C2B Janakpuri New 110058 C2B Janakpuri 110058 New Delhi DELHI 110049 Phone 9013072955 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Pragyan S Panda Query) Designation Assistant Professor Affiliation Janakpuri Super Speciality Hospital Society Address Janakpuri Super Speciality Hospital Society. Department of Microbiology 1st floor C2B Janakpuri New Delhi 110058 C2B Janakpuri New Delhi 110058 South 110058 India Phone 9013072955 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Pragyan S Panda Designation Assistant Professor Affiliation Janakpuri Super Speciality Hospital Society Address Janakpuri Super Speciality Hospital Society. Department of Microbiology 1st floor C2B Janakpuri New Delhi 110058 C2B Janakpuri New Delhi 110058 South West DELHI 110049

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India Phone 9013072955 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Janakpuri Super Speciality Hospital Society Primary Sponsor Primary Sponsor Details Name Janakpuri Super Speciality Hospital Society Address C2B Janakpuri New Delhi 110058 Type of Sponsor Other [Janakpuri Super speciality Hospital Society] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Pragyan S Panda Janakpuri Super Department of 9013072955 Speciality Hospital Microbiology 1st Floor Society C2B Janakpuri New pragyanpanda2006@g Delhi 110058 mail.com South West DELHI Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 16/02/2021 No Committee Janakpuri Super Speciality Hospital Society Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Health care workers who has not undergone COVID-19 vaccination Intervention / Type Name Details Comparator Agent Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Both Details HCWs of Janakpuri Super Speciality Hospital Society, who has not undergone COVID-19 vaccination. Exclusion Criteria Exclusion Criteria Details None Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints

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1. Will be able to evaluate the reasons amongst Cross- sectional study HCWs for not availing their turn to undergo for Qualitative evaluation of reasons amongst COVID-19 vaccination. HCWs for not availing their turn undergo COVID-19 vaccination Secondary Outcome Outcome Timepoints WIll assist to bring forth those apprehensions By means of a Cross sectional questionnaire and will further guide the COVID-19 vaccination based study there will be evaluation of reasons drive. for HCWs to forgo their turn for COVID-19 vaccination. Target Sample Size Total Sample Size=70 Sample Size from India=70 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 05/03/2021 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details nil Brief Summary

Title: “COVID-19 vaccination: The continuing dilemma of a health care worker”

This cross sectional questionnaire based study will be conducted at Janakpuri Super Speciality Hospital Society, an autonomous institute, under the aegis of Govt of NCT of Delhi. It is a 150 bedded hospital catering to super specialities like Neurology, Nephrology, Gastroenterology and Cardiology. Study participants will be enrolled amongst the health care workers, who have not availed their chance of vaccination as per the Govt. schedule. A pre-designed questionnaire will be filled by the study participants for demographic details, past medical history, record of any co-morbidities or prior COVID-19 infection and the reason/ reasons for not availing their turn to

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undergo vaccination. The questionnaire will have both open ended and closed ended questions and will be evaluated qualitatively. The questionnaire will be kept anonymous.

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