Ontario is a known leader in conducting innovative clinical trials, and the clinical trials community in Ontario has proven this strength throughout the COVID-19 pandemic. One innovative trial underway in Ontario is Vielight Inc.’s COVIDlight trial, which tests whether the recovery of COVID-19 patients may be accelerated by the use of a specialized light therapy device. This trial was made possible in part by Clinical Trials Ontario’s Trial Site Network through a connection made between Vielight Inc. and Impact Clinical Trials. CTO spoke with representatives from Vielight and Impact Clinical Trials about their trial and their experience with the Trial Site Network.
Vielight Inc. has developed a compact and portable device named the “Vielight RX Plus,” based on the science of photobiomodulation (PBM). PBM uses certain light energy to modify cellular functions and can play a role in the management of COVID-19. This clinical trial assesses the efficacy of the Vielight RX Plus to reduce symptom duration and severity in patients suffering from COVID-19.
The Vielight RX Plus device delivers light therapy to the sternum and the nasal canal.
“This device brings a holistic approach to the treatment of COVID-19 patients,”
said Nazanin Hosseinkhah, Research Scientist and Physicist at Vielight Inc.
“The device stimulates the thymus gland, creates nitric oxide, increases natural killer cells, acts as an anti-inflammatory therapy, and increases cellular energy.”
This unique, at-home study has the potential to modulate immune cell and cytokine activity in COVID-19 patients with an easy to use the device.
“We are very hopeful that this trial will prove to help patients recover from COVID-19 at home, and result in less burden to the healthcare system,”
said Hosseinkhah.
This randomized controlled trial, being managed by Impact Clinical Trials, is actively recruiting 280 participants who are confirmed to have contracted COVID-19. The trial was authorized by Health Canada in early September and is recruiting participants in Ontario and the United States. Participants are allocated into a treatment or a control group, with 140 participants randomized to receive the Vielight RX Plus device and the other 140 participants receiving the current standard of care. The trial is conducted remotely with non-hospitalized participants.
Participants in the treatment group receive the device by courier within 24 hours of registering for the trial. They are asked to place the device on their chest and onto their nostril for 20 mins each day. They then track their symptoms within a daily survey over a 30-day period.
“This is a simple, at-home study for participants to be involved in,”
said Andrea Berk from Impact Clinical Trials.
“Participants in both the treatment and the control groups are completely supported throughout the trial, with a 24-hour number they can call if they have any questions.”
This trial was made possible in part by a connection made directly through CTO’s Trial Site Network. The Trial Site Network, part of CTO’s Industry Concierge program, comprises more than 230 sites. The Network allows CTO to provide warm introductions to Ontario’s hospitals, research institutions, private research networks, and CROs.
“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 take on the management of 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.
