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0 0.5 1 1.5 2+ Symptomatic case 47% Improvement Relative Risk IgG positive 63% c19early.org/z Balmforth et al. CTRI/2021/04/032989 Zinc RCT Prophylaxis Is prophylaxis with zinc+multiple treatments beneficial for COVID-19? Double-blind RCT 648 patients in India (April - July 2021) Fewer symptomatic cases (p<0.0001) and lower IgG positivity (p<0.0001) Balmforth et al., J. Clinical Virology, doi:10.1016/j.jcv.2022.105248 Favors zinc Favors control
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.
Balmforth et al., Journal of Clinical Virology, doi:10.1016/j.jcv.2022.105248, CTRI/2021/04/032989
Balmforth et al., Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2.., Journal of Clinical Virology, doi:10.1016/j.jcv.2022.105248, CTRI/2021/04/032989
Jul 2022   Source   PDF  
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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 analysis: 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.
Contact: damian.balmforth@nhs.net.
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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 PII: DOI: Reference: S1386-6532(22)00180-9 https://doi.org/10.1016/j.jcv.2022.105248 JCV 105248 To appear in: Journal of Clinical Virology Received date: Revised date: Accepted date: 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 This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2022 Published by Elsevier B.V. 1 Title: Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention 2 of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial. 3 Damian Balmforth 1, James A Swales 2, Laurence Silpa 2,3, Alan Dunton 4, Kay E. Davies 5, 4 Stephen G. Davies 6, Archana Kamath 7, Jayanti Gupta 8, Sandeep Gupta 9, M. Abid Masood 5 2 , Áine McKnight 10, Doug Rees 2, Angela J. Russell 3,6, Manu Jaggi 11, Rakesh Uppal 1,12 6 7 (1) St Bartholomew’s Hospital, West Smithfield, London, EC1A 7BE, UK 8 (2) Raphael Labs Limited, 6 Derby Street, London, W1J 7AD, UK 9 (3) Department of Pharmacology, University of Oxford, Mansfield Road, Oxford, OX1 3QT, UK 10 (4) Danerius, LLC. Sarasota, Florida, USA 11 (5) Department of Physiology, Anatomy and Genetics, University of Oxford, Sir Henry 12 Wellcome Building of Gene Function, South Parks Road, Oxford, OX1 3PT, UK 13 (6) Department of Chemistry, University of Oxford, Chemistry Research Laboratory, Mansfield 14 Road, Oxford, OX1 3TA, UK 15 (7) Manipal Hospital & Research Center, Mangalore, Karnataka, India 16 (8) TrialGunva Pvt. LTd, Bengaluru, Karnataka, India 17 (9) Department of Pulmonology, Atharva Multispeciality Hospital & Research Centre, 18 Lucknow, Uttar Pradesh, India 19 (10) Queen Mary University of London, Blizard Institute, Barts and The London School of 20 Medicine and Dentistry, London, UK 21 (11) Althea Lifesciences, Sahibabad, Uttar Pradesh, India 22 (12) Queen Mary University of London, William Harvey Research Institute, Barts and The 23 London School of Medicine and Dentistry, London, EC1M 6BQ,..
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