"Abstract
Background: The COVID-19 pandemic continues to devastate communities all over the world. The aim of this study was to evaluate the efficacy and safety of the test agent as a prophylaxis against SARS-CoV-2 infection in a population of high-risk healthcare workers.
Methods: The study was a multi-centre, prospective, double blind, randomized, placebo-controlled trial. Key eligibility criteria included absence of significant co-morbidity and no previous SARS-CoV-2 infection or vaccination. Participants were randomised to either the active agent nasal spray or placebo using computer generated random number tables. The nasal spray was administered 3 times daily over a 45 day course...
Conclusion: The test agent significantly reduced SARS-CoV-2 infection in healthcare workers, with 62% fewer infections when compared to placebo. It was found to be safe and well tolerated and offers a novel treatment option for prophylaxis against SARS-CoV-2 infection.
1. Introduction
Rapid advances have been made in vaccination against SARS-CoV-2 and in the treatment of COVID-19. However, the virus continues to infect and kill people all over the world. Many low-income countries have difficulty obtaining vaccines or affording the more expensive therapies and globally there is a significant issue with vaccine hesitancy...
All the components in the test agent were deliberately selected to be inexpensive, stable, readily available globally and, most importantly, already described in Pharmacopeia or equivalent documents in several countries world-wide...
2. Methods
2.1. Composition of the test agent: The test agent was developed by Raphael Labs Ltd (London, United Kingdom) and formulated in collaboration with Dabur Research Foundation (Uttar Pradesh, India).
The components of the test spray include sterile water, polyethylene glycol 400, poloxamer 188, xylitol, 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, glycerol, and zinc chloride...
4. Discussion: The test agent has been shown to significantly reduce SARS-CoV-2 infections in high-risk healthcare workers, with 62% fewer infections compared to placebo... The benefits of the test agent spray were further supported by a significant reduction in symptoms when compared to placebo."
"Declaration of competing interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
JAS, LS, AD, KED, SGD, MAM, AM, RM, DR, AJR, and RU are shareholders of Raphael Labs LTD. JS is the managing director of Swales Pharma Consulting providing consulting services for a range of pharmaceutical companies. AJM and AR sit on the advisory board of Raphael labs."
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