Digital health company ResApp Health Limited (ASX:RAP) has recruited the first participant in its US-based clinical study to explore the relationship between cough and SARS-CoV2 (COVID-19) infection.
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.
CEO and Managing Director, Dr Tony Keating, said 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 Studyapplication (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.
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,” Dr Keating said.
“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.”