Vielight Launches COVID-19 Clinical Trial With Home-Use Device

Vielight Inc. is starting a new clinical trial in the United States. In this trial, the company will test the hypothesis that the recovery of patients who recently tested positive for COVID-19 infection may be accelerated by specialized light therapy.

The study intervention applies a combination of intranasally-delivered LED-based red light and LED-based near infrared (NIR) light to the body. For this purpose, Vielight has developed a compact and portable device named the “Vielight RX Plus”, which is suitable for home use. The intervention is based on the science of photobiomodulation (PBM) which utilizes certain light energy to modify cellular functions.
 
The hypothesis that the device is effective as a treatment for COVID-19 will be tested in a randomized controlled clinical trial. The research team is looking to recruit subjects who are between the ages of 18 and 65 years old, residents of the United States, and have been very recently diagnosed with a COVID-19 infection.
 
The trial will be conducted remotely with participants expected to stay at home during their participation and recovery. Investigators from Progressive Medical Research, located in Port Orange, Fla., will provide secure video consultations to communicate with the trial participants.
 
Research Supporting the 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 seek to prove the hypothesis 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. “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.”
 
Trial Format and Recruitment
The randomized controlled trial is expected to involve 280 participants who are confirmed to have COVID-19 infection. One hundred forty 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.