SARS-CoV-2 accelerated clearance using a novel nitric oxide nasal spray (NONS) treatment: A randomized trial
thelancet.com/journals/lansea/article/PIIS277...Posted Jul 13, 2022, 1:42 PM UTC
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thelancet.com
For subjects having a negative qualitative RT-PCR (RT-PCR negative) result at Day four, no RT-PCR assessments were done on Day eight.
This is quite disappointing in my opinion. The treatment was for 7 days, so a test afterward would have given us some insight on whether the treatment is just temporarily clearing the virus in the local area tested, or if the infection has actually been stamped out. I can’t help but feel this may have been deliberate
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“Interpretation Use of NONS in patients recently infected with SARS-CoV-2 accelerates nasal virus clearance.”
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Would a PDE5 inhibitor have any similar effect then?
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I’ve wondered the same thing. Or how about L-Arginine? would love to hear more discussion about this
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Ingredients: Sodium chloride, Citric acid, HPMC, Sodium nitrite, Benzalkonium Chloride. All components are used widely in the food industry and have a very strong safety profile. Do not use this product is you are sensitive to any of the ingredients
Not a chemist, but nitric oxide (NO) is a toxic pollutant that does show a strong effect against infection, and apparently NO can be produced by the reaction of citric acrid (essentially lemon juice) and sodium nitrite (processed meat preservative). But I have a feeling that the benzalkonium chloride (hand sanitizers, floor cleaners) is doing the heavy lifting here.
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Your body produces trillions of molecules of nitric oxide every second in the endothelium. It works anti-virally there.
Inhale in through your nose and your body adds a tiny amount of nitric oxide in the paranasal cavities which then gives your lungs and airways (breathe out through the mouth) an anti viral treatment.
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Nitrate in your diet (beetroot juice is best) is converted by your mouth bacteria to nitrite and in the gut to nitric oxide and then sent off for lots of important processes in your body.
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Using mouthwash disrupts this nitrate-nitrite-nitric oxide pathway.
(Various studies show that patients given mouthwash in hospital have higher morbidity than those not given it. An ICU doctor wrote a hypothesis about this in Oct 2020 in Intensive Care Magazine and recommended against antiseptic mouthwashes.)
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The first study of inhaled nitric oxide was published last week - showed better outcomes in pregnant women who had Covid-19.
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Does brushing teeth have a similar affect as mouthwash? Why or why not?
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Apparently even using antibacterial toothpaste doesn't reduce NO levels, which surprised me. Based on this I'd feel confident suggesting that non-antibacterial toothpaste is even less likely to cause a problem.
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The placebo solution had benzalkonium chloride as well
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Good catch. It's inclusion in the placebo is odd, if not suspicious. On one hand, it may reduce efficacy results. On the other, might it have been included to mask adverse effects? This paper touches on AEs corresponding to it.
It's also a bit curious they refer to it just as a preservative, and omit mention that it’s a biocidal / antimicrobial agent as well
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How is it suspicious? If they didn’t include it, you wouldn’t be able to tell if the effect was actually from the nitric oxide or the preservative.
Also it is a preservative. All preservatives are anti microbials, that is literally the whole point of preservatives.
The also do you think they don’t study adverse events in both groups? They do.
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I said "odd, if not suspicious." This study is for the SaNOtize / Enovid product (that's what the list of ingredients above corresponds to). Wouldn’t they want to determine the effect of the whole product, rather than just part of it?
I just figured it might be worth pointing out the biocidal attribute in the study & how the placebo may not actually be inert
Are you aware that the difference in AEs between treatment and placebo group is typically how safety is determined?
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The toxic pollutant is nitrous oxide. I think that’s NO2. Nitric Oxide is NO.
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“On Day two (≤ 24 hours on treatment), Day four (72 h on treatment), and Day eight (seven days on treatment; EOT) study site procedures included AE review, concomitant medication review, study medication compliance review, nasal swabs for RT-PCR, SpO2, MetHb, vital signs and investigator's WHO CPS score“
Where are the results of the above bolded items? The only thing I see in the Appendix along these lines is blood pressure.
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Can anyone comment on how significant dyslipidaemia and hypertriglyceridaemia are? From a quick google search it seems those are correlated with one another. Not sure what to make of those AEs in the treatment group. Hard to tell from the low numbers whether they're related or not
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Secondary objective / endpoint is stated as “proportion of patients achieving a two point change in WHO CPS Score on Day two, four, eight and 19. “ So why are they reporting results for day 8, 16, 18 and 20??
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“A significantly higher proportion of patients demonstrated a 2-point clinical status improvement on the WHO Progression Scale, the most clinically validated point system used in clinical trials, in the NONS group as compared to the placebo group in the high-risk group (p < 0.05).”
The above quote was from the earlier press release on this trial, but I don’t see evidence for that claim in this paper. Am I missing it? If not, that’s a red flag in my opinion
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There is an entire section dedicated to that.
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Yes, I don't see statistical significance. Unless they're cherry-picking day 16 for some odd reason (which is the only thing I see with p<.05)? Cherry-picking would be a red flag in itself, and perhaps even more so with day 16 which doesn't appear to have been registered as a day to examine for outcomes- see parallel comment
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As stated in the paper, the p-values are not corrected for multiplicity.
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Yes, and why not? I find it all the more odd they highlighted a p-value “for informational purpose only; not corrected for multiplicity” on a day (16) that was not intended to be observed (per registered protocols)
Regardless, where is the evidence of statistical significance for the claim they made in the earlier press release?
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Clinical trial updated last month. Press releases have announced a new Phase III trial. The updated info on the ongoing trial is here https://clinicaltrials.gov/ct2/show/NCT05109611
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If the spray goes in the nose, and the testing is a swab of the nose, how do we know the spray is not just masking the test?
Sorry if that's a dumb question.
Not a dumb question and one I have with all the nasal stuff. I think the takeaway here is the overall trends, it’s not that it just temporarily eliminate detectable covid via nasal swab, it’s that it decreases it over time faster than your body would without it.
Not a dumb question at all. It's an important question. I asked the company (SaNOtize) weeks ago via its Twitter account. I haven't received an answer on that one. They've answered quite a few of my other questions. Make of that what you will. I put more stock in the clinical / symptom data than the virological (PCR) data