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CTRI Number  CTRI/2020/12/030052 [Registered on: 28/12/2020] Trial Registered Prospectively
Last Modified On: 24/12/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   RESEARCH STUDY ON COVID19 ANTIBODIES IN HEALTH CARE WORKERS AT TERTIARY CARE HOSPITAL 
Scientific Title of Study   COVID19 SEROLOGY IN HEALTH CARE WORKERS AT TERTIARY CARE CENTRE 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhuvanamha Devi Ramamurthy 
Designation  Associate Professor 
Affiliation  SRM institute of Science and Technology 
Address  Department of Pathology SRM MCH and RC SRM institute of Science and Technology Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  8148840658  
Fax    
Email  drrbdevipath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhuvanamha Devi Ramamurthy 
Designation  Associate Professor 
Affiliation  SRM institute of Science and Technology 
Address  Department of Pathology SRM MCH and RC SRM institute of Science and Technology Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  8148840658  
Fax    
Email  drrbdevipath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhuvanamha Devi Ramamurthy 
Designation  Associate Professor 
Affiliation  SRM institute of Science and Technology 
Address  Department of Pathology SRM MCH and RC SRM institute of Science and Technology Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  8148840658  
Fax    
Email  drrbdevipath@gmail.com  
 
Source of Monetary or Material Support  
Research institution, SRM Medical College Hospital and Research Centre, SRM institute of Science and Technology 
 
Primary Sponsor  
Name  SRM 
Address  SRM MCH and RC 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
DrRBhuvanamha Devi Self  Department of Pathology SRM MCH RC Kattankulathur 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Bhuvanamha Devi  SRM Medical College Research Centre Kattankulathur  SRM nagar Kattakulathur
Kancheepuram
TAMIL NADU 		 8148840658

drrbdevipath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health care workers and volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All Health care workers working in SRM MCH & RC, Potheri
In Covid 19 – ICU Wards and OP clinic
In non-COVID 19 ICU Wards and OP Clinics
Without daily patient contact
Healthy individuals as Controls
 
 
ExclusionCriteria 
Details  Individuals with typical symptoms of COVID 19
Individuals not giving Consent for the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the sero-prevalence of IgG Sar-CoV2 in Health care workers who are exposed to COVID-19 patients, in SRM MCH&RC, Tertiary care Hospital.  4 to 8weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Identifying these individuals at earliest allows close follow-up for screening them to assess and prevent end organ damage.

To reassure our HCWs that they are not infected and to adhere, the same precautionary measures that they were following.
 		 10to12weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   20/01/2021 
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   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data requestors will need to sign data access agreement. Data will be made available through mail

  6. For how long will this data be available start date provided 20-01-2021 and end date provided 30-06-2021?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   For this study, we would be recruiting the Cases and Controls after scrutinizing through the questionnaire for their eligibility. 
The enrolled subjects shall be given Pretest and Post test counceling. 
Informed Consent shall be taken (Using bilingual english and tamil consent form). 
Demographic details shall be collected. 
Under aseptic precautions 2 ml of venous blood shall be collected in plain vacutainer. 
The serum will be separated andprocessed for detection of IgG COVID 19 antibodies
Statistical analysis will be done. Results  shall be interpreted
 
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