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CTRI Number  CTRI/2020/09/027881 [Registered on: 17/09/2020] Trial Registered Prospectively
Last Modified On: 28/10/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Serological Survey 
Study Design  Other 
Public Title of Study   An observational multi-center study on COVID 19 disease to study on HERD immunity 
Scientific Title of Study   An observational multi-center study on COVID 19 disease to study on HERD immunity in the population based on random sampling through conducting at two time points to infer epidemic trajectory. 
Trial Acronym  SARS-CoV2 infection Survey/2020 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijaykumar Patil 
Designation  Professor 
Affiliation  Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College & CPR Hospital, Kolhapur 
Address  CPR Hospital Bhausinghaji Road, Dasara Chowk,Kolhapur, Maharashtra, INDIA. Kolhapur MAHARASHTRA India

Kolhapur
MAHARASHTRA
416002
India 
Phone  9371877555  
Fax    
Email  mangovijay@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dhananjay Lad 
Designation  Director & Owner 
Affiliation  CROM Clinical Research & Medical Tourism Pvt. Ltd. 
Address  CROM Premises, Building no. 2, Opp. Caculo Mall, St. Inez, Panaji North Goa GOA India

North Goa
GOA
403001
India 
Phone  9158592177  
Fax    
Email  laddhl@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dhananjay Lad 
Designation  Director & Owner 
Affiliation  CROM Clinical Research & Medical Tourism Pvt. Ltd. 
Address  CROM Premises, Building no. 2, Opp. Caculo Mall, St. Inez, Panaji North Goa GOA India

North Goa
GOA
403001
India 
Phone  9158592177  
Fax    
Email  laddhl@gmail.com  
 
Source of Monetary or Material Support  
Public Health Department, Central Building, Bavada, Karveer, Kolhapur  
 
Primary Sponsor  
Name  Public Health Department 
Address  Kolhapur, Maharashtra 
Type of Sponsor  Other [Government Heath Department] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijaykumar Patil  Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College & CPR Hospital, Kolhapur  Room no. 7 Research Department, CPR Hospital Bhausinghaji Road, Dasara Chowk,Kolhapur, Maharashtra, INDIA. Kolhapur MAHARASHTRA
Kolhapur
MAHARASHTRA 		 9371877555

mangovijay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajarshee Chhatrapati Shahu Maharaj Government Medical College, Chhatrapati Pramila Raje General Hospital Kolhapur Institutional Ethics Committee II, (RCSMGMCIEC II),Kolhapur.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HERD immunity 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Apparently Healthy subjects will be recruited.
2.Subjects of both sexes aged more than 10 years old.
3.Willing and able to provide written informed consent
4.Subjects who has not tested positive for COVID 19 infection in the past. 
 
ExclusionCriteria 
Details  1.Subjects having less than 10 years of age
2.Subjects already tested positive for the COVID19 infection in the past and cured.
3.Critical co-morbidities.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Compared to the other infections, COVID infections are more asymptomatic and there is a chance to recover without any medications or standard of care for COVID-19 disease.  14 days 
 
Secondary Outcome  
Outcome  TimePoints 
There will be a chance to develop the antibodies or develop the resistance against the COVID-19 can be known as HERD immunity.

There will be reduction in spreading of the COVID infection through developing the immunity and wearing masks and taking all the precautions as per the WHO guidelines. 		 14 days 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "1192"
Final Enrollment numbers achieved (India)="1192" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/09/2020 
Date of Study Completion (India) 25/09/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   The IgM test will be done to determine the presence of antibodies developed against COVID-19 infection. The test will be performed in a manner to check that subject may having the infection without knowing and recovered without having any symptoms so it will be assumed that subject has developed the antibodies for the infection or subject has got the HERD immunity. The impact of risk factors which may alter the immunity in the different age group which will also be studied. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   COVID-19 is now spreading throughout the world because of its high infectivity and communicability. Also there is a lack in the proper management of the disease. So any contribution in the knowledge or treatment of COVID-19 from any source could be of great value to the medical profession. Thus the present study is proposed to understand the immunity developed by the own and fight against the COVID 19 virus in patients infected with COVID-19 infection. 
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