- ResApp Health has expanded its COVID-19 clinical program to include the collection of longitudinal data for positive COVID-19 subjects and recruit additional patients in India
- ResApp has engaged Triomics as a clinical trial partner to start-up and manage the study in India
- ResApp aims to develop a smartphone-based algorithm to instantly screen for COVID-19 and monitor disease progression using ResApp’s proprietary cough sound analysis technology
Brisbane, Australia, 9 August 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 advise that it has expanded its SARS-CoV2 (“COVID-19”) clinical program by including the collection of longitudinal data* for subjects who are COVID-19 positive. ResApp has also engaged Triomics, a clinical trial company based in India, to start recruitment of COVID-19 positive and negative patients in India.
As an expansion of ResApp’s US COVID Cough study (ref ASX announcement 11 March 2021), COVID Cough Study 2 (clinicaltrials.gov: NCT04989452) will enrol COVID-19 positive patients that have been identified in the first study and record cough sounds on day 1, day 10 and day 25 after enrolment. Data will also be collected on disease progression and any medical care received (such as hospitalisation). This additional data will allow ResApp to develop algorithms to remotely monitor patients with COVID-19 and help healthcare providers optimise medical care of these patients.
ResApp will work with Triomics to collect COVID-19 data in India and supplement the data currently being collected in the US. India is a global hotspot for COVID-19 with over 40,000 positive cases per day currently being recorded, including many with the Delta or Delta plus variants. Triomics’ unique digital R&D platform uses AI to match sites, identify potential patients and seamlessly manage clinical studies. Triomics works with over 100 hospitals across India to facilitate clinical trials for a broad range of the world’s leading health researchers, including pharmaceutical, vaccine and diagnostic companies. They have experience in conducting COVID-19 and device studies and are an ideal partner to support ResApp.
The Indian study aims to recruit 100 COVID-19 positive cases and 100 COVID-19 negative cases at three hospital-based sites and will use gold standard polymerase chain reaction (PCR) pathology testing as a reference standard. Longitudinal data will also be collected on the 100 COVID-19 positive cases. First patient recruitment is expected to occur in the coming weeks following Institutional Review Board (IRB) approval. Recruitment in India is estimated to be complete by the end of October.
CEO and Managing Director Dr Tony Keating said: “Recent events connected to the new Delta strain of COVID-19 have reinforced that we will be living with this disease for many years to come, even with high vaccination levels – as evidenced in Israel, the United Kingdom and the US. This study will build upon the data we are collecting in the US and further enhance our knowledge of COVID-19 and its variants.
“Collecting further data will support our efforts to develop smartphone-based tools to instantly screen for COVID-19 as well as help healthcare providers effectively manage patients who have a COVID-19 infection.
“We are pleased to be working with Triomics, who’s reach of over 100 hospitals across India and their novel clinical research platform will enable us to rapidly execute this study. We look forward to updating shareholders on first patient recruitment and developments in the coming weeks.”
* Longitudinal data involves repeated observations of the same data at different points in time and can provide insights on how the patient and their disease progresses over time.
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.