- First participant enrolled in US clinical study to investigate the relationship between cough and COVID-19 and develop an instant COVID-19 screening smartphone app
- Participants enrol and participate in the study using the COVID-Cough Study app for iPhone which is available on the App Store
- Participants provide a cough sample and undergo simultaneous RT-qPCR at-home saliva-based testing to determine COVID-19 status
- Preliminary study data expected next quarter
Brisbane, Australia, 17 May 2021 — ResApp Health Limited (ASX:RAP), a leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease, is pleased to report that it has recruited the first participant in its US-based clinical study to explore the relationship between cough and SARS-CoV2 (“COVID-19”) infection (refer ASX announcement: 11 March 2021).
First participant recruitment follows approval from an institutional review board (IRB) that assessed and approved the ethical design of the study. The study is registered on clinicaltrials.gov (NCT04864535).
Ongoing recruitment initiatives are now underway, with additional marketing being undertaken to expedite the enrolment process. The study aims to recruit up to 1,500 asymptomatic and symptomatic individuals during the next three months. To be eligible to enrol in the study participants must be aged 21 years or older and be a resident of the United States.
Participants will enrol in the study using the COVID-Cough Study application (“app”) for iPhone which is now available on the App Store. Once enrolled, study participants use the app to record a cough sample and complete a Phosphorus medical form. A test kit order will then be submitted and if approved by a physician, they will be sent a COVID-19 RT-qPCR at-home saliva test within 24 hours.
Participants will then provide a saliva sample, an additional cough sample, and return the completed test kit via courier to Phosphorous’ CAP-accredited and CLIA-certified lab for PCR testing. The participant will receive their COVID-19 RT-qPCR test result within 48 hours.
ResApp looks forward to providing ongoing updates to shareholders on recruitment and data analysis.
CEO and Managing Director Dr Tony Keating said: “We are pleased to have recruited our first participant and commenced a study that has the potential to lead to the creation of a robust and accurate algorithm which could instantly detect whether or not an individual has COVID-19 using a smartphone.
“Recruitment initiatives will ramp up over the coming weeks and with the US reporting approximately 30,000 positive COVID-19 cases per day we expect to complete recruitment quickly. This study will allow ResApp to create a high-quality data set which can be used for algorithm training and other potential initiatives including COVID-19 prevention strategies.
“We anticipate that the algorithm will become an important and useful tool for governments, healthcare providers, service providers in a number of industries, employers and individuals and we look forward to updating shareholders on our progress.”
About ResApp Health Limited
ResApp Health Limited (ASX: RAP) is a leading digital health company developing smartphone applications for the diagnosis and management of the respiratory disease. ResApp’s machine learning algorithms use sound to diagnose and measure the severity of respiratory conditions without the need for additional accessories or hardware. ResApp’s regulatory-approved and clinically validated products include ResAppDx, a smartphone-based acute respiratory disease diagnostic test for use in telehealth, emergency department and primary care settings; and SleepCheck, a smartphone application which allows consumers to self-assess their risk of sleep apnoea. Both products are CE Marked in Europe and TGA approved in Australia. For more information, please visit www.resapphealth.com.au.
ResApp Health Limited
ABN 51 094 468 318
Level 12, 100 Creek St, Brisbane, QLD 4000
© 2021 ResApp Health Limited. All rights reserved. US Patent No. 10,098,569, Australian Patent No. 2013239327, Japanese Patent No. 6,435,257, South Korean Patent No. 1020812410000 and Patents Pending. ResApp Health®, the ResApp Health logo and ResAppDx® are registered trademarks of ResApp Health Limited in the United States and other countries. ResAppDx is not available for sale in the United States.