| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 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 |
|
|
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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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) |