Professor Jeong Hwan-jeong (Department of Nuclear Medicine, School of Medicine) has begun the first clinical trial in common cold patients to verify the clinical effectiveness of the respiratory disease therapeutic device "Bye-Vi," which applies an integrated optical-energy proximal irradiation technology he developed last year.

This clinical trial is being led by Professor Hong Yong-tae of the Department of Otolaryngology at Jeonbuk National University (JBNU) Hospital. The clinical trial plan involving common cold patients underwent review by the Ministry of Food and Drug Safety and the JBNU Hospital Institutional Review Board and received final approval. Recruitment of clinical trial participants will begin on the 17th.

The research on this technology advanced in the context of securing treatment technologies during the COVID-19 pandemic. The team was the first to confirm that a specific light energy suppresses proliferating viruses, and a therapeutic device applying this finding was developed. However, research and clinical trials that should have been conducted on COVID-19 patients were blocked because current definitions of infectious disease treatment include only vaccines and therapeutics, and inflexible regulations on the designation of clinical trial institutions prevented validation of the device’s effects.

The research team appealed repeatedly for improvement of these issues, but with little change they shifted course to demonstrate antiviral effects in common cold patients instead of COVID-19 patients, leading to the present clinical trial.

The team began this research in January 2020. In a study published last September in the photobiology SCI international journal Photochemistry & Photobiology, they reported that a specific light source is effective not only against SARS-CoV-2 but also in suppressing replication of respiratory viruses such as influenza, and that the antiviral mechanism occurs by inhibiting various host cell processes the virus exploits for replication.

Based on these findings, in April of last year the team developed the world’s first therapeutic device that delivers light energy to the nose and throat of COVID-19 patients to inactivate or suppress the virus. The device completed electrical safety and biological safety testing in November of last year and passed medical device safety verification. Clinical application to verify the antiviral effect in patients has now just begun.

If this clinical trial in common cold patients is followed by application in COVID-19 Omicron patients, it is expected not only to enable early treatment and suppression of infectivity among confirmed COVID-19 patients but also to shorten treatment duration and reduce medical expenses.

The research team stated, "While the commercialization process for this technology has encountered difficulties domestically, in the United States a medical device with a similar concept has already obtained approval to proceed to Phase 3 clinical trials and those trials are underway. Although the U.S. trial progress can be interpreted as contemporaneous scientific development, it is regrettable that we may miss an opportunity for Korea to lead in this area."

They added, "The first clinical trial in common cold patients involves a small number of participants, so it should not take much time. Based on these results, if clinical trials are conducted at COVID-19-dedicated hospitals or among confirmed persons in self-quarantine with coordinated support from the Ministry of Health and Welfare, the Korea Disease Control and Prevention Agency, and local governments, Bye-Vi will clearly contribute to treating confirmed patients and preventing community transmission."

Meanwhile, those who wish to participate in the ongoing clinical trial involving common cold patients may contact the JBNU Hospital Medical Device Clinical Trial Center (063-259-3466) or visit the center in person to enroll.

If the therapeutic device, developed domestically for the first time in the world, demonstrates treatment effects beyond the common cold against variants such as Omicron, stealth Omicron, and Deltacron, it is expected to help normalize abnormal medical circumstances.