The trial will validate the Vielight RX Plus as an effective therapeutic device to speed up the recovery of Covid-19 patients
Canada-based Vielight has commenced the enrolment of patients in a Covid-19 trial in Ontario to validate the efficacy of its home-use therapeutic device.
Health Canada has authorised the trial to validate the Vielight RX Plus as an effective therapeutic device to boost the recovery of patients who recently tested positive for Covid-19 infection.
The company already started the trial of the Vielight RX Plus device in the US.
Vielight RX Plus devices offers both LED-based red light intranasally and near infrared (NIR) light to the body.
According to the company, the intervention is based on the science of photobiomodulation (PBM), which uses certain light energy to modify cellular functions.
The company will recruit patients between the ages of 18 and 65 years old in the trial
The company aims to evaluate subjects between the ages of 18 and 65 years old in Ontario who were recently diagnosed with a Covdi-19 infection in the trial.
Vielight stated that the trial will be carried out remotely with non-hospitalised subjects who have recently tested positive for Covid-19 and Ontario-based investigators will offer secure video consultations to communicate with the trial participants.
The company plans to recruit 280 participants with Covid-19 infection in the randomised controlled trial, of which 140 participants will be randomised to the active Vielight RX Plus protocol and other 140 participants will be randomised to the standard care regimen.
Vielight will measure the success in this trial by the time to recovery over a 30-day study period.
Based in Toronto of Canada, Vielight is involved in the development and distribution of low-risk photobiomodulation general wellness devices.
Vielight PBM devices are evaluated in multiple active clinical trials. The trials comprise assessing the use of Vielight PBM devices for Alzheimer’s disease, traumatic brain injury, and other institutional PBM research projects.
Vielight founder and CEO Dr Lew Lim said: “We have designed the Vielight RX Plus with specific parameters based on PBM research that are relevant to impacting coronavirus infections. By conducting this study, we are looking to prove that the Vielight RX Plus will accelerate recovery and reduce the severity of the viral infection.
“It’s affordability, comfort and suitability for home-use are important features needed for widespread adoption. We now need to evaluate through this clinical trial, whether it will also be effective.”
In August this year, Digital Diagnostics secured the German Federal Institute for Drugs and Medical Devices (BfArM) approval for the clinical study of its Digid Cantisense SARS-CoV-2 test.