Ontario light therapy clinical trial aims to accelerate recovery from COVID-19

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 is testing 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.

Light therapy device for the treatment of COVID-19

Vielight Inc. has developed a compact and portable device named the “Vielight RX Plus”, which is based on the science of photobiomodulation (PBM). PBM uses certain light energy to modify cellular functions and has the potential to play a role in the management of COVID-19. This clinical trial is assessing 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 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.

Clinical trial format and recruitment

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 of the participants randomized to receive the Vielight RX Plus device, and the other 140 participants receiving 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.”

Making connections through the Trial Site Network

This trial was made possible in part by a connection made directly through CTO’s Trial Site Network. Andrew Haller, Industry Outreach Associate at CTO, was able to utilize the Trial Site Network to connect Vielight and Impact Clinical Trials in order to get this trial underway. The Trial Site Network, part of CTO’s Industry Concierge program, is comprised of 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 provide guidance to 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 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.

This is just one of the many connections made through the Trial Site Network. “We have connected more than 60 incoming industry trials and validation studies to over 80 potential site partners,” said Haller. “CTO is proud to support the clinical trials community in Ontario to advance COVID-19 research,” said Susan Marlin, President and CEO of CTO.

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