FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/09/036581 [Registered on: 16/09/2021] Trial Registered Prospectively
Last Modified On: 10/05/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   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 = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praveen Chabukswar  Ajanta Superspeciality Hospital  Harsool Rd, N-13, Wankhede Nagar, Mahmoodpura, Aurangabad, Maharashtra 431003
Aurangabad
MAHARASHTRA 
8600718400

prvnchbkswr@gmail.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 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 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 Shyam Mukundan  Lakshmi Nursing Home  Palace Road, Aluva, Ernakulam , Kerala, 683101
Ernakulam
KERALA 
7356793054

drshyamresearch@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 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 Ajay Abhimanyu Bulle  Meditrina Institute of Medical Sciences  278, Central Bazar Road, Ramdaspeth, Nagpur, Maharashtra- 440012
Nagpur
MAHARASHTRA 
9823515550

researchngp@gmail.com 
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 Aneesh Raj  NIMS, Medicity  NIMS Medicity, Aralummoodu, P.O.,Neyyattinkara, Thiruvananthpuram- 695123 , Kerala, India
Thiruvananthapuram
KERALA 
9539688684

draneeshraj@gmail.com 
Dr Harsh Mittal  Panchsheel Hospital Pvt Ltd  C3/63A, 64A, Yamuna Vihar, Delhi-110053
New Delhi
DELHI 
9560506410

harshmittal86@gmail.com 
Dr Pravin Kamble  Saikrupa Hospital  Renuka corner, Tapkir chowk, Thergaon, Pune, Maharashtra 411033
Pune
MAHARASHTRA 
9372074767

drpravinkamble@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 18  
Name of Committee  Approval Status 
Asian Cancer Hospital Ethics Committee Jaipur  Approved 
Bioethics Independent Ethics Committee  Approved 
Ethics Committee Panchsheel Hospital, New Delhi  Approved 
Ethics Committee Panchsheel Hospital, New Delhi  Approved 
Ethics Committee, Ajanta Superspeciality Hospital, Aurangabad  Approved 
Institutional Ethics Committee for Sehgal Nursing Home  Approved 
Institutional Ethics Committee Government Medical College, Kozhikode   Approved 
Institutional Ethics Committee Malabar Medical College Hospital  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 
Mavens Institutional Ethics Committee  Approved 
Meditrina Institute Ethics Committee, Nagpur  Approved 
NIMS IEC  Approved 
Saikrupa Hospital Institutional Ethics Committee, Pune  Approved 
Scientific Research & Ethics Review Committee, Batra Hospital and Medical Research Center, New Delhi  Approved 
The Indus Hospital Institutional 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  
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:
(i)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 COVID-19 rt-PCR or rt-qPCR
test in the preceding 48 hours; or
(ii)at a study site and is needing a COVID-19
rt-PCR or rt-qPCR test.
 
 
ExclusionCriteria 
Details  Participant has one or more medical contraindication to voluntary cough, including the following:
1. Severe respiratory distress;
2. History of pneumothorax; Eye, chest, or abdominal surgery within 3 months of enrolling in the study;
3. Patients requiring continuous oxygen or ventilator support; and
4. Hemoptysis (coughing up of blood) within 1 month of enrolling for the study; or
5. Patients 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   Total Sample Size="220"
Sample Size from India="220" 
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   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

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 – particularly for developing world countries – and ultimately these tests can’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:

  1. 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

  2. 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

  3. 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

  4. 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

 
Close