After confirmed exposure to COVID-19, infection rate in participants (n=625) who took NONS™ was 6.4% versus 25.6% in the control group (P<0.0001)
The new data build upon previously reported Phase III trial results demonstrating that a rapid reduction of viral load prevents progression to infection after COVID-19 exposure
VANCOUVER, British Columbia, May 11, 2022--(BUSINESS WIRE)--SaNOtize Research and Development ("SaNOtize") today announced results from a retrospective clinical study assessing the efficacy of nitric oxide releasing nasal spray (NONS™) in preventing COVID-19 infection after high-risk exposure. Nitric oxide is a naturally occurring molecule known to have antimicrobial properties, including a direct effect on SARS-CoV-2 and its variants, the virus that causes COVID-19. The new study, conducted at Srinakharinwirot University in Bangkok, Thailand, found participants who took NONS after COVID-19 exposure were 75% less likely to become infected when compared to the control group, yielding a statistically significant reduction in infection rate.
"The results of this study using real-world evidence suggest NONS is an effective self-administered tool to prevent COVID-19 infection, even after high-risk exposure," said lead author Jarinratn Sirirattawan, MD, Assistant Professor, Srinakharinwirot University, Ongkharak site, Thailand. "In previous randomized controlled, Phase III, clinical trials, NONS was also shown to be effective in rapidly reducing the duration of disease by 50% in participants who had already acquired COVID-19, suggesting it is a promising tool for both treatment and prevention."
The study was carried out during an emergency effort by the University to contain an Omicron outbreak in February, 2022. Medical personnel, students, and professors (1,039 individuals, aged 18-60) were quarantined in dormitories after possible COVID-19 exposure. Individuals were included in the current analysis if they had confirmed high-risk exposure to a COVID-19 infected roommate (defined as being within one to two meters of the infected individual for at least five minutes without a mask). NONS was offered to staff and students who reported exposure.
After exclusion for being low-risk or testing positive via antigen test kit (ATK) within 24 hours, 625 student participants were included in the analysis. Of these, 203 participants used NONS at least four times per day and 422 volunteers did not use NONS. All volunteers were tested via ATK on the fifth, seventh, and tenth day of quarantine, and positive tests were confirmed by PCR.
Among the 203 participants who used NONS, 13 tested positive (6.4% infection rate). Of the 422 in the control group, 108 participants tested positive (25.6% infection rate), a statistically significant difference from the treatment group (P<0.0001). Participants in the NONS group reported only a mild side effect of nasal irritation (8 of the 203, or 3.9%).
The study will be submitted for publication in a peer-reviewed journal.
"Given the rate at which COVID-19 continues to mutate, and the consensus that it will soon be endemic, we need to expand the tools at our disposal to protect against it," said Chris Miller, PhD, Chief Scientific Officer and co-founder of SaNOtize. "The mounting evidence for NONS is promising, as it suggests a safe and effective tool in our evolving strategy against COVID-19. We are excited to look more closely at its potential role in COVID-19 prevention, including our upcoming Phase III trial in Canada for which we are currently recruiting up to 4,000 participants."
NONS is not yet approved for sale in Canada or USA. It is approved as a medical device under the brand name VirXTM in Thailand and as a medical device under the brand name of enovid™ in Indonesia, Israel, and Bahrain. In India, NONS received an emergency use approval by the Central Drugs Standard Control Organization (CDSCO) for treatment of adult patients with COVID-19 who have a risk of progression of the disease. In Singapore and Nepal, it is registered as a Class I medical device and under CE mark in the European Union.
SaNOtize Research & Development Corp. is a pharmaceutical company based in Vancouver, BC, commercializing the multi-faceted antimicrobial properties of a liquid producing nitric oxide. The company developed and patented a first-in-class nitric oxide releasing solution to treat and prevent upper respiratory and topical infections. For more information, visit www.SaNOtize.com.
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