| CTRI Number |
CTRI/2021/09/036489 [Registered on: 14/09/2021] Trial Registered Prospectively |
| Last Modified On: |
09/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Device validation study for detecting likely presnce of COVID-19 |
|
Scientific Title of Study
|
Development, validation, pilot deployment of an ultra scalable technology SWAASA AI, as an auxiliary to COVID 19 rapid test. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P V Sudhakar |
| Designation |
Professor and Head |
| Affiliation |
Andhra Medical College |
| Address |
Department of Plastic Surgery, Andhra Medical College, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530002
India |
| Phone |
08912561157 |
| Fax |
|
| Email |
amc_vsp@nic.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmalatha Pentakota |
| Designation |
MD (Gen Medicine) |
| Affiliation |
Andhra Medical College |
| Address |
Dept of General Medicine, Andhra Medical College, Visakhapatnam
Andhra Medical College
Visakhapatnam
ANDHRA PRADESH
530002
India |
| Phone |
9246620072 |
| Fax |
|
| Email |
padmalathamdgen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Narayana Rao Sripada |
| Designation |
Founder / Director |
| Affiliation |
Salcit Technologies Private Limited |
| Address |
FLAT NO 408,DREAM CASTLE NIZAMPET ROAD, KUKATPALLY
FLAT NO 408,DREAM CASTLE NIZAMPET ROAD, KUKATPALLY
Medchal
TELANGANA
500090
India |
| Phone |
9945399533 |
| Fax |
|
| Email |
svn@salcit.in |
|
|
Source of Monetary or Material Support
|
| Cellular and Molecular Platforms, GKVK Post, Bellary Road, Bengaluru, Karnataka 560 065 |
|
|
Primary Sponsor
|
| Name |
Cellular and Molecular Platforms |
| Address |
GKVK Post, Bellary Road, Bengaluru, Karnataka 560 065 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Padmalatha Pentakota |
King George Hospital, Andhra Medical College |
CSR block, King George Hospital and Isolation Ward, King George Hospital, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH |
9246620072
padmalathamdgen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, King George Hospital, Visakhapatnam, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects not having any respiratory symptoms |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patients, 18 years of age and over.
Patients able to read, understand and sign the Informed Consent Form.
Newly diagnosed COVID 19 Patients.
|
|
| ExclusionCriteria |
| Details |
Patients less than 18 years of age
Pregnant females.
Asymptomatic patients attending isolation ward for COVID testing
Patients on ventilators support
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Validation of the SWAASA AI Platform in detecting likely presence of COVID-19 by comparing with the final clinical diagnosis based on test results of a standard reference test or tests. |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate the effectiveness of Swaasa AI platform in detecting COVID-19 in a primary health care setting |
2 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="656" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2021 |
| Date of Study Completion (India) |
17/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Since the COVID 19 pandemic people
all over the world have been experiencing devastating consequences as it
spreads very rapidly with significant risks of mortality and morbidity. In this
scenario we need to remember the quotation “Prevention is better than cure†and
it will be possible only with early detection which results in decrease in the
mortality rate as well as rate of spread of the disease. The
Swaasa AI platform is a
revolutionary approach to respiratory healthcare. It is a highly effective platform
that maintains the functionality of Spirometry by removing the constraints of
cost, location, scheduling, special equipment, and trained personnel. Swaasa AI
platform provides patients with increased accessibility by enabling them to use
their personal mobile devices for testing.
The core technology is based on
audiometric analysis of cough (and/or lung) sounds using our patented Machine
Learning (ML) algorithm residing in our Swaasa.AI engine in the cloud. The
system has been validated through a registered clinical
trial
in India. Our work has also resulted in peer-reviewed
publication.
We are now extending the platform to
study cough sound characteristics of COVID-19. This will help in detecting the
likely presence of COVID19 based on a combination of cough sound analysis and a
subset of questions from SGRQ. The Swaasa platform monitors dry cough count,
wet cough count, oxygen saturation and respiratory rate over a period of time
this provides physicians a comprehensive and longitudinal view of their
patient’s symptoms.
|