Subjects: HEALTH, LIFESTYLE, MISCELLANEOUS, MISCELLANEOUS, MISCELLANEOUS
Vielight Commences Recruitment for COVID-19 Clinical Trial in Ontario
Toronto, Canada, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Vielight Inc. is pleased to announce the commencement of recruitment for a COVID-19 clinical trial in Ontario, Canada. This involves a home-use device the "Vielight RX Plus" to accelerate recovery from COVID-19 infection. The trial was authorized by Health Canada on September 3, 2020. Recruitment for the trial, which recently started in the US, will now be extended to Ontario.
In this trial, Vielight Inc. is looking for clinical evidence to validate the Vielight RX Plus as an effective therapeutic device to accelerate the recovery of patients who recently tested positive for COVID-19 infection. The device delivers a combination of LED-based red light intranasally and near infrared (NIR) light to the body. The intervention is based on the science of photobiomodulation (PBM), which utilizes certain light energy to modify cellular functions.
This randomized controlled clinical trial is seeking to study subjects who are between the ages of 18 and 65 years old, residents of Ontario, Canada and have been very recently diagnosed with a COVID-19 infection.
The trial will be conducted remotely with non-hospitalized subjects who have recently tested positive for COVID-19. Investigators based in Ontario will provide secure video consultations to communicate with the trial participants.
The Research Supporting this Clinical Trial
"The body of published research on PBM and related coronavirus infection etiology suggest that PBM may be effective in inhibiting the replication of coronaviruses. It could boost the activities of the immune system while managing the risk of inflammation", said Dr. Michael Hamblin, Associate Professor Emeritus at Harvard Medical School and Massachusetts General Hospital. "PBM is also recognized for its healing properties, which may aid recovery."
"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", said Dr. Lew Lim, Founder and CEO of Vielight Inc. "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."
The Clinical Trial Format and Recruitment
The randomized controlled trial is expected to involve 280 participants who are confirmed to have COVID-19 infection. 140 of the participants will be randomized to the active Vielight RX Plus protocol, and the other 140 participants will be randomized to the standard care regimen, only. Recruitment for participants is currently open; it will close when the target number of 280 qualified participants is reached.
Data will be captured electronically from online questionnaires. Support and oversight are carried out by medically qualified investigators, with all best-practice safety measures in place. There will be no human contact, and all communications are relayed remotely. Success in this trial is measured by the time to recovery over a 30-day study period.
About Vielight Inc.
Vielight Inc. is a privately held company based in Toronto, Canada. The company develops and supplies low risk photobiomodulation general wellness devices globally. Vielight holds the reputation as one of the most active companies in research and development in the field of PBM. Vielight PBM devices are investigated in a number of active clinical trials. These trials include investigation of the use of the Vielight PBM devices for Alzheimer's disease, traumatic brain injury, and other institutional PBM research projects. More information about Vielight Inc. can be found at https://vielight.com.
Information on the clinical trial is available at https://clinicaltrials.gov/ct2/show/NCT04418505.
Potential subjects should call 1-800-517-8010 or email [email protected] for trial participation enquiries. For more information about the trial recruitment please visit www.covidlight.ca.
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