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CTRI Number

CTRI/2021/09/036581 [Registered on: 16/09/2021] Trial Registered Prospectively

Last Modified On:

01/03/2023

Post Graduate Thesis

Type of Trial

Observational

Type of Study
Modification(s)

Observational Study

Study Design

Other

Public Title of Study

A Pilot Study for the Collection Of Vocalized Individual Digital Cough Sounds from patients with suspected COVID-19 in India

Scientific Title of Study

A Pilot Study for the Collection Of Vocalized Individual Digital Cough Sounds from patients with suspected COVID-19 in India

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name
Designation
Affiliation
Address
Phone
Fax
Email

Details of Contact Person
Scientific Query
Modification(s)

Name	Suresh Kumar Karri
Designation	Sr. Project Manager
Affiliation	Triomics Healthcare Private Limited
Address	Level 5, Green Boulevard, Block C, Sector 62 Noida Uttar Pradesh 201 301 India Gautam Buddha Nagar UTTAR PRADESH 201310 India
Phone	9739798272
Fax
Email	suresh.karri@triomics.in

Details of Contact Person
Public Query
Modification(s)

Name	Suresh Kumar Karri
Designation	Sr. Project Manager
Affiliation	Triomics Healthcare Private Limited
Address	Level 5, Green Boulevard, Block C, Sector 62 Noida Uttar Pradesh 201 301 India Gautam Buddha Nagar UTTAR PRADESH 201310 India
Phone	9739798272
Fax
Email	suresh.karri@triomics.in

Source of Monetary or Material Support

ResApp Health Limited Level 12, 100 Creek Street Brisbane QLD 4000 Australia

Primary Sponsor

Name	ResApp Health Limited
Address	Level 12, 100 Creek Street Brisbane QLD 4000 Australia
Type of Sponsor	Other [Technology Company]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 45
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Akshay Budhraja	Aakash healthcare super speciality hospital	Hospital Plot, Road No 201, Dwarka Sector3, New Delhi, Delhi 110075 New Delhi DELHI	9893322007 dr.akshaybudhraja@gmail.com
Dr R P Rajesh	Adhavvan Diabetes and Research Centre	No 46C, Bharatheeswarar Colony Main Road, Kodambakkam, Chennai 600024, Chennai Chennai TAMIL NADU	9629394222 doctorrpr@gmail.com
Dr Praveen Chabukswar	Ajanta Superspeciality Hospital	Harsool Rd, N-13, Wankhede Nagar, Mahmoodpura, Aurangabad, Maharashtra 431003 Aurangabad MAHARASHTRA	8600718400 prvnchbkswr@gmail.com
Dr Manav Manchanda	Asian Institute of Medical Sciences	Badkal Flyover, Road, Sector 21A, Faridabad, Haryana 121001 Faridabad HARYANA	9650099137 manav.manchanda@aimsindia.com
Dr Suninder Singh Arora	Batra Hospital & Medical Research Center	1, Tughlakabad institutional Area Mehrauli Badarpur Road, New Delhi-110062 New Delhi DELHI	9810113414 drssarora@gmail.com
Dr Sundeep Nayar	BLK-Max Super Speciality Hospital	Rajendra Place, Pusa Road, New Delhi -110005 New Delhi DELHI	9810006781 sandeep.nayar@blkhospital.com
Dr Arunkumar Radhakrishnan	Chettinad Hospital and Research Institute	Chettinad Health City, SH 49A, Kelambakkam, Tamil Nadu 603103 Chennai TAMIL NADU	9778425561 drarunresearch2020@gmail.com
Dr Clarence J Samuel	Christian Medical College and Hospital	CMC - Ludhiana Ludhiana PUNJAB	9988099867 clarencejs@yahoo.com
Dr Akhil Gupta	Clinton Multispeciality Hospital	84, Vinobha Vihar, Model Town, Malviya Nagar, Jaipur Jaipur RAJASTHAN	7007590702 clinitonbiologics@gmail.com
Dr Dhananjaya B	Dinka Multispecialty Clinic and Center for Diabetes	N0. 30/1, Madhu Building, Kodichikkanahalli Last Bus Stop Bangalore KARNATAKA	9740183373 dinkaresearch@gmail.com
Dr Baraneedharan	Dr Baranee Sukra Diabetes Care and Research Centre	7th Ave, Ashtalaxmi Garden, Besant Nagar, Chennai, Tamil Nadu 600090 Chennai TAMIL NADU	9841113009 way2baranee@gmail.com
Dr Tummuru Venkata Reddy	Evya Multispeciality Hospital	Mansoorabad Rd, Sharada Nagar, Indira Nagar, Vanasthalipuram, Telangana 500070 Hyderabad TELANGANA	9951209564 venkatesh.induss@gmail.com
Dr SSVV Narsinga Rao	Government Medical College and Government Medical Hospital	GMC & GMH (Old RIMSGGH), Srikakulam, 532001, Andhra Pradesh Srikakulam ANDHRA PRADESH	8942279033 gghsrikakulam@gmail.com
Dr Rojith Balakrishnan	Government Medical College and Hospital	GMC, Kozhikode, Kerala Kozhikode KERALA	9746006050 drrojith@gmail.com
Dr P Venkatesh	Indus Hospital	Krishnaveni Nagar, Gaddiannaram, Near Municipal Office, Saroornagar - 500060 Hyderabad TELANGANA	9440383778 drvenkat22@gmail.com
Dr Bushna Bavumon	Iqraa International Hospital and Research Centre	Wayanad Rd, Malaparamba, Kozhikode, Kerala 673009 Kozhikode KERALA	9746450380 drbushbavumon22@gmail.com
Dr Rakesh Patil	Kasturi Medicare Pvt. Ltd	Harshniketan, Gaondevi Road, Behind Navrang Hotel, Bhayandar West Maharashtra, India-401303 Mumbai MAHARASHTRA	8356003006 drrakeshpatil04@gmail.com
Dr Sriharee Kulkarni	Kulkarrnis Medzone	G D Naidu Hall, Mohan Matrix, 450, 12th Cross Rd, near Vidya Bharathi School, Mahalakshmipuram, Bengaluru, Karnataka 560086 Bangalore KARNATAKA	9611271177 drsriharee@gmail.com
Dr Shyam Mukundan	Lakshmi Nursing Home	Palace Road, Aluva, Ernakulam , Kerala, 683101 Ernakulam KERALA	7356793054 drshyamresearch@gmail.com
Dr Mantri Sumant Narayan	Life Speciality Clinic	889, 28 Main Road, Corporation Colony, Jayanagar 9 Block Bangalore KARNATAKA	9481594148 svhospital1997@gmail.com
Dr Sreenivasulu Madduri	Likhitha Diagnostics	No.3-3-12/A, Hanumanagar,BesidePranhitha Hospitals, Dilshuknagar Hyderabad TELANGANA	8555856991 seenuh21@gmail.com
Dr Mohammed Mirvaz Zulfikar	Malabar Medical College Hospital & Research Centre	Department of General Medicine, P.O.Modakkallur, Atholi, Kozhikode, KERALA, 673623 Kozhikode KERALA	04962701800 mohammedmzulfikar@gmail.com
Dr Satyanarayana Mysore	Manipal Hospital	#98, Old Madras Hospital, Kodihalli, Bangalore - 560017 Bangalore KARNATAKA	9741303009 drsatya.research@gmail.com
Dr Aman Maggo	Mata Roop Rani Mahindru Maggo Hospital	Om Vihar Phase 1 Rd, Phase 1A, Om Vihar, Uttam Nagar, Delhi, 110059 New Delhi DELHI	9999900043 amanmaggo84@gmail.com
Dr Payal Mathur	Mavens Hospital	N37, LANE OPPOSITE RELIANCE FRESH, VAISHALINAGAR, AJMER Ajmer RAJASTHAN	9413827905 drpayalmathur@yahoo.com
Dr Ranganatha R	Mazumdar Shah Medical Center a unit of Narayana Health	#258/A, Bommasandra Industrial Area, Hosur Road, Anekal Talk, Bangalore 560099 Bangalore KARNATAKA	9740200774 rrpulmo@gmail.com
Dr Ajay Abhimanyu Bulle	Meditrina Institute of Medical Sciences	278, Central Bazar Road, Ramdaspeth, Nagpur, Maharashtra- 440012 Nagpur MAHARASHTRA	9823515550 researchngp@gmail.com
Dr Santosh	Medray Diagnostic Centre	16, Sanjay Nagar Main Rd, NGEF Layout, Raj Mahal Vilas 2nd Stage, Sanjayanagara, Bengaluru, Karnataka 560094 Bangalore KARNATAKA	9900000524 drsanthosh@medray.in
Dr V Chakravarthy	Metrocure Hospital	16-2-661/EFGH, Street Number 1, beside Bajaj Electronics, Judges Colony, Malakpet, Hyderabad, Telangana 500036 Hyderabad TELANGANA	9603366902 chakravarthy.metrocure@gmail.co
Dr Nidhi Raveendran	NIMS, Medicity	NIMS Medicity, Aralummoodu, P.O.,Neyyattinkara, Thiruvananthpuram- 695123 , Kerala, India Thiruvananthapuram KERALA	9605887365 nidhiraveendran1995@gmail.com
Dr Z N Quraishi	Noor Nursing Home	Jogeshwari West, Mumbai, Maharashtra, India-401100 Mumbai MAHARASHTRA	9322404338 noorimagingcentre@yahoo.com
Dr Harsh Mittal	Panchsheel Hospital Pvt Ltd	C3/63A, 64A, Yamuna Vihar, Delhi-110053 New Delhi DELHI	9560506410 harshmittal86@gmail.com
Dr Nanthini Devi	Panimalar Medical College Hospital and Research Institute	Varadharajapuram, Chennai Outer Ring Rd, Poonamallee, Chennai, Tamil Nadu 600123 Chennai TAMIL NADU	9840856073 nandhu.smiley7@gmail.com
Dr Pravin Soni	PCMCS PGI Yashwantrao Chavan Memorial Hospital	SantTukaram Nagar, Pimpiri colony,Pune,Maharashtra-411018 Pune MAHARASHTRA	9822057511 drpravinsoni18@gmail.com
Dr Prashanth C	PKTB Mysore	KRS Rd, Kumbarakoppal, Gokulam, Mysuru, Karnataka 570002 Bangalore KARNATAKA	8147299390 prshnthcr@gmail.com
Dr Nagaraja C	Rajiv Gandhi Institute of Chest Diseases	Someshwaranagara Dharmaram College Post, 1st Main Rd, near NIMHANS, Bengaluru, Karnataka 560029 Bangalore KARNATAKA	8026088500 drnagaraja.rgicd@gmail.com
Dr Pravin Kamble	Saikrupa Hospital	Renuka corner, Tapkir chowk, Thergaon, Pune, Maharashtra 411033 Pune MAHARASHTRA	9372074767 drpravinkamble@gmail.com
Dr Poorna Prasad	Shettys Hospital	Plot No, 11 and 12, 12th F Main Rd, Kaveri Nagar, Bommanahalli, Bengaluru, Karnataka 560068 Bangalore KARNATAKA	9741941064 spoornaprasad123@gmail.com
Dr Vijay Babu	SKS Hospital and Postgraduate Medical Institute	23, SKS Hospital Rd, Guptha Nagar, Alagapuram Periyaputhur, Salem, Tamil Nadu 636004 Salem TAMIL NADU	9944196155 drvijaymd@hotmail.com
Dr Sadhana S M	Sri Venkateshwara Hospital	BTM 2nd Stage, Kuvempu Nagar, Stage 2, BTM Layout, Bengaluru, Karnataka 560076 Bangalore KARNATAKA	9448474377 svhospitalresearch@gmail.com
Dr Suda Amarnath Reddy	Srushti Hospital	Kodichikkanahalli Main Road, Near BWSSB, Kaveri Water Tank, Bangalore, Karnataka, India Bangalore KARNATAKA	9003154951 drsudaamarnathreddy@gmail.com
Dr Suresh SM	Suresh Dia Care	723-B, 11th Main Road, 3rd Block, Rajajinagar- 560010 Bangalore KARNATAKA	9844011862 sureshhospital@gmail.com
Dr Dilip Shah	Vijay Vallabh Hospital And Medical Research Centre	423, Tirupati Nagar, Phase 1, Bolinj, Virar West Mumbai MAHARASHTRA	9820324286 drdilipshah04@gmail.com
Dr Hansraj Alva	Vinaya Hospital and Research Center	Karangalpady, Mangalore-575003 Dakshina Kannada KARNATAKA	9343562622 hansalva2001@yahoo.com
Dr Dhaiwat shukla	VS General Hospital	VS General Hospital, Ellisbridge, Ahmedabad Ahmadabad GUJARAT	9654775195 dr.dhaiwatshukla89@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 45
Name of Committee	Approval Status
Asian Cancer Hospital Ethics Committee Jaipur	Approved
Bangalore Ethics Committee	Approved
Bangalore Ethics Committee	Approved
Bioethics Independent Ethics Committee	Approved
Ethics Committee of Maniple Hospitals	Approved
Ethics Committee Panchsheel Hospital, New Delhi	Approved
Ethics Committee Panchsheel Hospital, New Delhi	Approved
Ethics Committee Vinaya Hospital	Approved
Ethics Committee, Ajanta Superspeciality Hospital, Aurangabad	Approved
Ethics Committee, SDS TRC and RGICD	Approved
IEC Mysore Medical College and Research Institute	Approved
IEC, Asian Institute of Medical Sciences	Approved
Institutional Ethics Committee Akash Super speciality Hospital	Approved
Institutional Ethics Committee for Sehgal Nursing Home	Approved
Institutional Ethics Committee Government Medical College, Kozhikode	Approved
Institutional Ethics Committee Iqraa International Hospital and Research Centre	Approved
Institutional Ethics Committee Malabar Medical College Hospital	Approved
Institutional Ethics Committee PMCHRI	Approved
Institutional Ethics Committee, Christian Medical College and Hospital	Approved
Institutional Ethics Committee, Dr. BL Kapur Memorial Hospital, New Delhi	Approved
Institutional Ethics Committee, GMC & GMH	Approved
Institutional Ethics Committee, Madonna Hospital and Research Center, Ernakulam	Approved
Institutional Human Ethics Committee for Faculty Research	Approved
Madonna Hospital and Research Centre	Approved
Mavens Institutional Ethics Committee	Approved
Meditrina Institute Ethics Committee, Nagpur	Approved
Narayana Health Medical Ethics Committee	Approved
NIMS IEC	Approved
Royal Pune Independent Ethics Committee	Approved
Saikrupa Hospital Institutional Ethics Committee, Pune	Approved
Scientific Research & Ethics Review Committee, Batra Hospital and Medical Research Center, New Delhi	Approved
Shah Lifeline Hospital and Heart Institute Ethics Committee	Approved
Shah Lifeline Hospital and Heart Institute Ethics Committee	Approved
Shah Lifeline Hospital and Heart Institute Ethics Committee	Approved
Shettys Ethics Committee	Approved
Shettys Hospital Ethics Committee	Approved
Shettys Hospital Ethics Committee	Approved
Shettys Hospital Ethics Committee	Approved
Shrey Hospital IEC	Approved
SKS Hospital Ethics Committee	Approved
Sri Venkateshwara Hospital Ethics Committee	Approved
The Indus Hospital Institutional Ethics Committee	Approved
The Induss Hospital Ethics Committee	Approved
The Induss Hospital Institutional Ethics Committee	Approved
Universal Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

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

Inclusion Criteria
Modification(s)

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1. be aged 18 years and older 2. be able to provide informed consent 3. be willing to follow study procedures 4. be able to provide at least 5 coughs (voluntary and/or spontaneous) and 5. Is either â€¢ an in-patient at a study site who are experiencing mild to moderate symptoms of COVID- 19 based on the ICMR guidelines, and has undergone a positive COVID19 rtPCR or rtqPCR test in the preceding 48 hours (not applicable to v 0.2 protocol) or â€¢ at a study site and is needing a COVID19 rtPCR or rtqPCR test.

ExclusionCriteria

Details

1. Participant has one or more medical
contraindication to voluntary cough,
including the following
o Severe respiratory distress
o History of pneumothorax;
o Eye, chest, or abdominal surgery
within 3 months of enrolling for
the study
o Hemoptysis (coughing up of
blood) within 1 month of
enrolling for the study or
o Patient is requiring continuous
oxygen or ventilator support.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

Collection of cough sound recordings, current medical symptoms, and medical history on a single occasion from 120 COVID-19 negative or positive participants as identified by PCR.

Collection of cough sound recordings, current medical symptoms, medical history, and medical treatment information on 3 distinct occasions (day 0, day 2, day 4) from 100 individuals with a known positive COVID-19 PCR result.
To develop a post data collection algorithm to detect COVID-19 and the severity of COVID-19 and determine the accuracy of the developed algorithm with a combination of collected cough sound analysis and medical symptoms to detect COVID-19 and the severity of COVID-19 using PCR as a reference standard.

Screening/Baseline Visit, Day 2 and Day 4.

Secondary Outcome

Outcome	TimePoints
N/A	N/A

Target Sample Size
Modification(s)

Total Sample Size="8000"
Sample Size from India="8000"
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)

22/09/2021

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
Modification(s)

Years="1"
Months="6"
Days="15"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary
Modification(s)

The novel coronavirus (SARS-CoV-2) has spread rapidly around the globe and caused widescale physical, mental, and economic damage. A key component for countries to effectively navigate this pandemic is the ability to screen for COVID-19 disease and triage individuals en masse rapidly and effectively. This ability to rapidly screen for COVID-19 is beginning to emerge with widespread testing capacity, however cost and access is a major rate limiting factor â€“ particularly for developing world countries â€“ and ultimately these tests canâ€™t predict disease severity.
The technology currently exists to effectively screen for diseases such as pneumonia, asthma, and COPD using a combination of unique sound patterns contained within cough sounds and subject reported symptoms, and thus we believe the same machine learning technology can offer similar efficacy for COVID-19. If so, this screening tool would provide a rapid, safe, and low-cost mechanism to identify COVID-19 positive individuals.
This study therefore seeks to gather cough sound samples from eligible study participants and using rt-PCR and rt-qPCR as our reference standards, analyze their cough sound recordings along with subject reported symptoms to explore four hypotheses:
There is a unique sound pattern observable in the cough sounds of COVID-19 positive individuals that is distinguishable from COVID-19 negative individuals and cough sounds of COVID-19 positive individuals change in a predictable manner over time
An artificial intelligence algorithm with a high degree of sensitivity and specificity can be developed to indicate the presence of COVID-19 using cough sounds alone, or a combination of cough sounds and subject reported symptoms
An algorithm with a high degree of sensitivity and specificity can be developed to triage COVID-19 positive individuals based on their likely need for medical treatment using longitudinal cough sounds alone, or a combination of longitudinal cough sounds and subject reported symptoms
An algorithm with a high degree of sensitivity and specificity can be developed to predict the COVID-19 rt-qPCR Cycle Threshold value for COVID-19 positive individuals