Diagnostics, Health Tech

ObvioHealth to collect data for virtual Covid-19 registry study after app gets clearance

The company launched the study to collect data on Covid-19 symptoms and immune responses earlier this month. The goal is to recruit 10,000 participants and then follow them for six months. Participants developing symptoms will be eligible for serological testing.

As Covid-19 quickly evolved from a local outbreak in a central Chinese city to a global pandemic, virtual health research company ObvioHealth sprang into action.

The Orlando, Florida-based company said earlier this month that it had started a virtual symptom and immune response registry for Covid-19 that will enroll up to 10,000 participants who connect via mobile devices and then follow them for six months, with the entire study expected to take 12 months.

“We had to take the lead – to take a jump and put together this clinical trial ourselves to find the best way to learn about this infection,” said Matty Notaro, ObvioHealth’s senior vice president for global operations, in a phone interview. Data from the study – in which participants must consent to participate – will be shared with the scientific community and also be available for use by drug and diagnostics companies, she added.

Although it began recruitment on April 2 and was posted to ClinicalTrials.gov last Thursday, as of Tuesday the study was still listed as not yet recruiting. Notaro explained that “quite a number” of patients have already registered for the study, but it can’t yet collect data on them because it is still awaiting approval for the accompanying mobile app from Google Play. “Apple and Google are being very mindful of the Covid-19 apps getting approved,” she said.

The company said that findings from the study will offer insights into how some of Covid-19’s symptoms evolve, some of the risk factors associated with infection and specific immune responses, which can then inform global health policy. Participants who have tested positive or who begin to show symptoms of the disease may be sent a rapid finger-prick serological assay kit – once those kits become available in the U.S. – in order to assess their immune responses, with test results reported through the app. The app will then give users reminders so they can input how their symptoms have progressed and resolved over the course of the study, including visits to clinics, hospitalization or further testing. Referrals to telehealth support will be available for participants who show serious symptoms.

Photo: Hiraman, Getty Images