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.
This study is excluded in meta
combined treatments may contribute more to the effect seen.
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.
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.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Balmforth et al., 25 Jul 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
Abstract: Journal Pre-proof
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.
Damian Balmforth , James A Swales , Laurence Silpa ,
Alan Dunton , Kay E. Davies , Stephen G. Davies ,
Archana Kamath , Jayanti Gupta , Sandeep Gupta ,
M. Abid Masood , Áine McKnight , Doug Rees , Angela J. Russell ,
Manu Jaggi , Rakesh Uppal
To appear in:
Journal of Clinical Virology
9 May 2022
20 July 2022
24 July 2022
Please cite this article as: Damian Balmforth , James A Swales , Laurence Silpa , Alan Dunton ,
Kay E. Davies ,
Stephen G. Davies ,
Archana Kamath ,
Jayanti Gupta ,
Sandeep Gupta ,
M. Abid Masood , Áine McKnight , Doug Rees , Angela J. Russell , Manu Jaggi , Rakesh Uppal ,
Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARSCoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial., Journal of Clinical
Virology (2022), doi: https://doi.org/10.1016/j.jcv.2022.105248
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Title: 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.
Damian Balmforth 1, James A Swales 2, Laurence Silpa 2,3, Alan Dunton 4, Kay E. Davies 5,
Stephen G. Davies 6, Archana Kamath 7, Jayanti Gupta 8, Sandeep Gupta 9, M. Abid Masood
, Áine McKnight 10, Doug Rees 2, Angela J. Russell 3,6, Manu Jaggi 11, Rakesh Uppal 1,12
(1) St Bartholomew’s Hospital, West Smithfield, London, EC1A 7BE, UK
(2) Raphael Labs Limited, 6 Derby Street, London, W1J 7AD, UK
(3) Department of Pharmacology, University of Oxford, Mansfield Road, Oxford, OX1 3QT, UK
(4) Danerius, LLC. Sarasota, Florida, USA
(5) Department of Physiology, Anatomy and Genetics, University of Oxford, Sir Henry
Wellcome Building of Gene Function, South Parks Road, Oxford, OX1 3PT, UK
(6) Department of Chemistry, University of Oxford, Chemistry Research Laboratory, Mansfield
Road, Oxford, OX1 3TA, UK
(7) Manipal Hospital & Research Center, Mangalore, Karnataka, India
(8) TrialGunva Pvt. LTd, Bengaluru, Karnataka, India
(9) Department of Pulmonology, Atharva Multispeciality Hospital & Research Centre,
Lucknow, Uttar Pradesh, India
(10) Queen Mary University of London, Blizard Institute, Barts and The London School of
Medicine and Dentistry, London, UK
(11) Althea Lifesciences, Sahibabad, Uttar Pradesh, India
(12) Queen Mary University of London, William Harvey Research Institute, Barts and The
London School of Medicine and Dentistry, London, EC1M 6BQ,..
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