Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial.
648 patient RCT pHOXWELL nasal spray in India, showing significantly lower IgGS+ and significantly lower symptomatic cases with treatment.
pHOXWELL includes a combination of natural virucidal agents and is designed to mimic the fluid surrounding healthy cells. The spray included xylitol, zinc chloride, polyethylene glycol 400, poloxamer, disodium hydrogen phosphate, sodium chloride, hydroxypropyl methylcellulose, ginger oil, eucalyptus oil, basil oil, clove oil, sodium hydrogen carbonate, potassium dihydrogen phosphate, ethylenediaminetetraacetic acid, sodium hyaluronate, calcium chloride dihydrate, benzalkonium chloride, magnesium chloride hexahydrate, potassium chloride, and glycerol. The spray was administered up to three times per day (TID) 140 μl/nostril for 45 days, with a gap of 6-8 hours between doses.
risk of symptomatic case, 47.4% lower, RR 0.53, p < 0.001, treatment 57 of 275 (20.7%), control 112 of 281 (39.9%), NNT 5.2, odds ratio converted to relative risk.
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risk of IgG positive, 62.7% lower, RR 0.37, p < 0.001, treatment 36 of 275 (13.1%), control 97 of 281 (34.5%), NNT 4.7, adjusted per study, odds ratio converted to relative risk, multivariable.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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This study is excluded in meta
analysis:
combined treatments may contribute more to the effect seen.
Balmforth et al., 7/25/2022, Double Blind Randomized Controlled Trial, placebo-controlled, India, peer-reviewed, 15 authors, study period April 2021 - July 2021, this trial uses multiple treatments in the treatment arm (combined with multiple treatments) - results of individual treatments may vary, trial CTRI/2021/04/032989.
Contact:
damian.balmforth@nhs.net.