Phase III trial for COVID-19 prevention (ongoing)
SaNOtize is enrolling participants in a Phase III efficacy study to evaluate NONS™ as an antiviral preventing COVID-19 infection. This double-blinded, placebo controlled clinical trial is Health Canada-approved and is recruiting up to 4,000 volunteers in Canada and Sri Lanka.
Clinical trial registry: Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection
For Canadian site enrollment information, please see here.
Retrospective clinical study for COVID-19 prevention after exposure(completed April 2022)
Participants in the recent study included 625 students at a university in Thailand that was undergoing quarantine for an Omicron outbreak. Those with confirmed exposure to COVID-19 were offered the option to take nitric oxide nasal spray (NONS™) as a possible preventive measure against infection. Nitric oxide is a naturally occurring molecule known to have antimicrobial properties, including a direct effect on SARS-CoV-2, the virus that causes COVID-19. Those who chose to use NONS™ (203 participants) sprayed it intranasally at least four times daily (422 volunteers chose not to use NONS). The infection rate in participants who took NONS™ was 6.4% versus 25.6% in the control group (P<0.0001), representing a significant reduction in infection risk of 75%. Adverse events were all mild (nasal discomfort, 3.9% of NONS participants).
Phase III clinical trial for COVID-19 treatment
(completed Jan 2022)
This study was a randomized, double-blind, placebo-controlled study that took place at 20 clinical sites across India and enrolled 306 patients who had contracted COVID-19. In the NONS™ treatment group, the SARS-CoV-2 viral load was reduced by more than 94% within 24 hours of treatment, and by more than 99% in 48 hours, compared to participants using a saline nasal spray (placebo). The median time to a negative PCR test in this group was 4 days in the treatment group compared with 8 days in the control. More patients taking NONS™ were also asymptomatic by the end of the 16-day study compared to those taking placebo. Mild adverse events were observed in NONS participants (6.5%, nasal discomfort) compared to 2.7% in the placebo group.
Although the study was designed only to assess treatment, it also looked at infection rates of people in close contact with study participants: the NONS household infection rates remained stable, while infections in placebo households increased, hinting at a potential role in prevention (no statistics were run on the close contacts data).
Phase II clinical trial for COVID-19 treatment(completed Mar 2021, published in the Journal of Infection, Aug 2021)
This randomized, double-blind, placebo-controlled trial evaluated use of NONS in early treatment of 80 confirmed cases of COVID-19 in the UK. Use of NONS™ 5-6 times daily for nine days significantly reduced participants’ levels of SARS-CoV-2, the virus that causes COVID-19, including in participants with high viral loads. For participants using NONS™, the average viral load reduction in the first 24 hours was 95%, and with 72 hours, the viral load dropped by more than 99%. Resolution of symptoms was also faster on NONS treatment than on placebo. No serious (SAE), severe or moderate adverse events were reported in NONS participants. Two SAEs were reported in the placebo group.
Data was published at the Journal of Infection:
Web link: Clinical efficacy of nitric oxide nasal spray (NONS) for the treatment of mild COVID-19 infection
PDF: Clinical efficacy of nitric oxide nasal spray (NONS) for the treatment of mild COVID-19 infection
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