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Ontario is recognized for leading innovative clinical trials, and the province’s research community has demonstrated this strength throughout the COVID-19 pandemic. One ongoing study is Vielight Inc.’s COVIDlight trial, which is evaluating whether a specialized light-therapy device might shorten recovery time for COVID-19 patients. The trial was facilitated in part by Clinical Trials Ontario’s Trial Site Network, which connected Vielight Inc. with Impact Clinical Trials. CTO spoke with representatives from both organizations about the study and their experience with the network.
Vielight Inc. has developed a compact, portable device called the “Vielight RX Plus,” based on photobiomodulation (PBM). PBM uses specific wavelengths of light to influence cellular activity and may help manage COVID-19 symptoms. The trial is examining whether the device can reduce the duration or severity of symptoms in people with COVID-19.
The RX Plus delivers light to the sternum and nasal cavity.
“This device offers a holistic approach for COVID-19 patients,”
said Nazanin Hosseinkhah, research scientist and physicist at Vielight Inc.
“It stimulates the thymus gland, promotes nitric-oxide release, may increase natural-killer-cell activity, provides anti-inflammatory effects, and can boost cellular energy.”
This at-home study is exploring whether the device can modulate immune-cell and cytokine activity in a convenient way.
“We hope the trial will support faster home recovery and ease pressure on the healthcare system,”
said Hosseinkhah.
Impact Clinical Trials is managing this randomized, controlled study, which aims to enroll 280 participants with confirmed COVID-19. Authorized by Health Canada in early September, the trial is recruiting in Ontario and the United States. Participants are randomly assigned to receive either the RX Plus device plus standard care or standard care alone. The study is conducted remotely with non-hospitalized volunteers.
Treatment-group participants receive the device by courier within 24 h of enrollment and are asked to apply it to the chest and nostril for 20 min daily, then record symptoms in a daily survey for 30 days.
“This is a simple, at-home study,”
said Andrea Berk of Impact Clinical Trials.
“Both treatment and control participants have 24-hour access to study staff for questions.”
The collaboration was enabled by CTO’s Trial Site Network, part of the Industry Concierge program. The network includes more than 230 Ontario hospitals, research institutes, private networks, and CROs, allowing CTO to provide direct introductions.
CTO Trial Site Network Search ongoing trials
“We have been able to guide companies such as Vielight in getting their trials up and running in Ontario,”
said Andrew Haller.
“I was introduced to Andrew Haller from CTO a few months before the COVID-19 pandemic,”
said Berk.
“Pre-COVID I was working on half a dozen connections that had been made through the Trial Site Network. When COVID-19 hit, those projects were put on hold. I reached out to Andrew to let him know Impact Clinical Trials had the consulting capacity, and that is when he introduced us to Vielight.”
Haller knew that Vielight had been searching for someone to manage their clinical trial. “When Andrew introduced us to Andrea Berk from Impact Clinical Trials, we immediately connected and knew they were the right fit,” said Hosseinkhah.
