This is the first randomized, placebo-controlled, single-blind clinical study of Steriwave™ nasal photodisinfection in 75 predominantly vaccinated COVID-19 patients to be published.

The study, published in Frontiers in Cellular and Infection Microbiology,[1] met its primary endpoint, with a highly significant decrease in viral infectivity recorded as early as two days after treatment (p<0.0001). By contrast, patients in the placebo control arm, who underwent simulated treatment without the active components being applied, were non-responsive (p=0.24). No serious adverse events were reported. 

Steriwave therapy also significantly improved the immune-protective status of treated patients, as measured by PCR testing one week after treatment (over six times fewer PCR-positive patients compared to controls).  These results were paralleled by significant improvement in the patient-reported symptoms of chest tightness and headache.

The study was conducted at the Clínica Universidad de Navarra, a tertiary teaching hospital in Pamplona, Spain during the highly contagious sixth Omicron (B.1.1.529) outbreak in late 2021 and early 2022. This sixth SARS-CoV-2 wave in Spain was characterized as a “perfect storm” resulting in record numbers of new infections due to the combination of fewer restrictions in place, waning immunity offered by COVID-19 vaccines and the more contagious Omicron strain. Over 90% of the patients recruited into the study were fully vaccinated.

In an important additional finding, study researchers demonstrated that Steriwave photodisinfection substantially prolonged patient immunity against SARS-CoV-2 at 20 weeks after treatment.  This effect was detectable not only in antibody-mediated immunity (short-term antibody response to infection, or to mRNA vaccines, which fades relatively quickly), but also in T-cell mediated immunity (the long-term immune system “memory” capable of rapidly responding to future viral infections). 

Lead author, co-principal investigator, and Head of Occupational Medicine at the Clínica Universidad de Navarra Dr. Alejandro Fernandez-Montero commented “This randomized, controlled study shows that photodisinfection could be an effective and safe novel treatment for SARS-CoV-2 carriers, significantly decreasing the infectivity period. Most exciting is the demonstration of an adaptive immune response in treated patients. This is the basis of vaccination, and it means that nasal decolonization might provide an alternative, low-cost, widely accessible, respiratory virus treatment during future pandemics. The treatment specifically helped to maintain, over time, the cell-mediated immunity, which is remarkable as this is the immune protection needed against severe disease.”

Dr. José Luis Del Pozo, Head of Infectious Diseases Division and Clinical Microbiology at the Clínica Universidad de Navarra, Co-principal Investigator, and Study Author, commented “This study expanded our understanding of SARS-CoV-2 pathogenesis, because interestingly, we showed that treatment with aPDT applied only to the nasal passages also reduced SARS-CoV-2 colonization of the nasopharyngeal region. This implies that we might be able to slow viral spread from the upper to the lower respiratory tract, reducing the extent of illness and thereby reducing pressure on hospital facilities such as the ICU.  It also means that we might be able to slow or inhibit viral spread from person to person during an outbreak, in both clinical and non-clinical settings, even when those patients have been previously vaccinated.”

Carolyn Cross, Ondine Biomedical’s CEO stated “ The Clínica Universidad de Navarra study sheds new light on the photodisinfection treatment of respiratory viruses, where antibiotics are entirely ineffective and new anti-viral therapies are limited. As new SARS-CoV-2 variants rapidly emerge across the globe, we look forward to being able to play our part in helping our communities, hospitals, clinics, and emergency workers deal with these new threats.”

[1] Frontiers in Cellular and Infection Microbiology, 25 January 2023, Sec. Virus and Host, Volume 13.