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CTRI Number  CTRI/2020/06/026005 [Registered on: 21/06/2020] Trial Registered Prospectively
Last Modified On: 12/06/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   retrospective 
Study Design  Other 
Public Title of Study   Pooled testing for COVID 
Scientific Title of Study   Validation of SARS CoV-2 RT-PCR testing using combinatorial tapestry pooling of samples: a multi-centre study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya Ranganathan 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Room No 71 Department of Anaesthesiology Main Building Tata Memorial Hospital Ernest Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  24177000  
Fax  912224146937  
Email  drpriyaranganathan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Omshree Shetty 
Designation  Scientific Offcier, Molecular Pathology 
Affiliation  Tata Memorial Centre 
Address  Department of Pathology 7th Floor, Annexe Building Tata Memorial Hospital Ernest Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax  912224146937  
Email  omshreens@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Omshree Shetty 
Designation  Scientific Offcier, Molecular Pathology 
Affiliation  Tata Memorial Centre 
Address  Department of Pathology 7th Floor, Annexe Building Tata Memorial Hospital Ernest Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax  912224146937  
Email  omshreens@gmail.com  
 
Source of Monetary or Material Support  
National Centre for Biological Sciences, Rajiv Gandhi Nagar, Kodigehalli, Bengaluru, Karnataka 560065 India  
 
Primary Sponsor  
Name  National Centre for Biological Sciences 
Address  Rajiv Gandhi Nagar, Kodigehalli, Bengaluru, Karnataka 560065 India  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manoj Gopalkrishnan  Indian Institute of Technology Bombay  Department of Mechanical Engineering, IIT Bombay, Powai, Mumbai, Maharashtra 400076
Mumbai
MAHARASHTRA 
912225722545

manoj.gopalkrishnan@gmail.com 
Dasaradhi Palakodeti  Institute for Stem Cell Science & Regenerative Medicine (inStem)  Das Lab, inStem, GKVK - post, Bellary Road, Bangalore 560065, Karnataka, India
Bangalore
KARNATAKA 
08023666001

dasaradhip@instem.res.in 
R Parthiban  Malabar Cancer Centre  DEpartment of Microbiology, Malabar cancer centre, MCG Rd, lltathaazha, Thalassery, Kerala 670103
Kannur
KERALA 
04902355881

parthi71975@gmail.com 
Uma Ramakrishnan  National Centre for Biological Sciences  Uma Ramakrishnans Lab, National Centre for Biological Sciences, Rajiv Gandhi Nagar, Kodigehalli, Bengaluru, Karnataka 560065 India
Bangalore
KARNATAKA 
918023666001

uramakri@ncbs.res.in 
Omshree Shetty  Tata Memorial Centre  Depatment of Molecular Pathology, Annexe Building, Dr. E Borges Road, parel, Mumbai - 400 012
Mumbai
MAHARASHTRA 
912224177000

omshreens@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
IIT Bombay IEC  Approved 
inStem IEC  Approved 
Malabar Cancer Centre IEC  Approved 
NCBS IEC  Approved 
Tata Memorial Hospital IEC1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  The results of individual testing will be taken as the gold standard. We will compare the results of the pooled sampling against this 
Intervention  nil  This is a diagnostic validation study, using previously collected samples, which will be carried out independently, in parallel at each of the participating centres. Samples will be subjected to individual testing will be performed as per the COVID-19 testing workflow by CSIR-CCMB following ICMR guidelines.In addition, samples will be subjected to pooled sampling - simple pooling and combinatorial tapestry pooling based on a computerised sensing algorithm.  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  samples of nasopharyngeal swabs submitted for COVID testing to each of the participating centres as per current testing guidelines 
 
ExclusionCriteria 
Details  nil 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is the sensitivity and specificity of combinatorial tapestry
pooling technique as compared to individual testing, across various prevalence rates and degrees of pooling. 
baseline 
 
Secondary Outcome  
Outcome  TimePoints 
The sensitivity and specificity of the simple pooled technique as compared to individual technique,
across various prevalence rates and degrees of pooling 
baseline 
The sensitivity and specificity of each level of combinatorial tapestry pooling as compared to simple pooling at the same level.  baseline 
Cost per individual for each of the three types of testing (for negative and positive tests) at different
levels of pooling 
baseline 
 
Target Sample Size   Total Sample Size="321"
Sample Size from India="321" 
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)   22/06/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Brief Summary  
COVID is caused by the SARS CoV2 virus. Currently, we are testing individuals for the presence of the virus using nasal swabs. The cost of this test and the shortage of testing kits limits the number of tests that can be performed.
It has been shown that pooling of samples from different individuals is a cost-effective way to test for the presence of virus. In this study, we plan to compare two methods of pooling samples. The study will be carried out on samples which have already been collected for individual testing and no additional samples will be collected from individuals. The results of the pooled testing will be compared with the results of the individual tests (which will be carried out as standard of care)
 
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