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Pathogenesis-based preexposure prophylaxis associated with a low risk of SARS-CoV-2 infection in healthcare workers at a designated COVID-19 hospital: a pilot study

Authors
  • Dubina, Michael V.1, 2
  • Gomonova, Veronika V.3
  • Taraskina, Anastasia E.3
  • Vasilyeva, Natalia V.3
  • Sayganov, Sergey A.3
  • 1 State Research Institute of Highly Pure Biopreparations FMBA Russia, 7 Pudozhskaya str, St. Petersburg, 197110, Russia , St. Petersburg (Russia)
  • 2 Russian Academy of Sciences, 14 Leninskiy pr, Moscow, 119991, Russia , Moscow (Russia)
  • 3 North-Western State Medical University named after I.I. Mechnikov of Ministry of Health of Russian Federation, 41 Kirochnaya str, St. Petersburg, 191015, Russia , St. Petersburg (Russia)
Type
Published Article
Journal
BMC Infectious Diseases
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Jun 07, 2021
Volume
21
Issue
1
Identifiers
DOI: 10.1186/s12879-021-06241-1
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundAt present, no agents are known to be effective at preventing COVID-19. Based on current knowledge of the pathogenesis of this disease, we suggest that SARS-CoV-2 infection might be attenuated by directly maintaining innate pulmonary redox, metabolic and dilation functions using well-tolerated medications that are known to serve these functions, specifically, a low-dose aerosolized combination of glutathione, inosine and potassium.MethodsFrom June 1 to July 10, 2020, we conducted a pilot, prospective, open-label, single-arm, single-center study to evaluate the safety and efficacy of preexposure prophylaxis (PrEP) with aerosolized combination medication (ACM) on the incidence of SARS-CoV-2 positivity in 99 healthcare workers (HCWs) at a hospital designated for treating COVID-19 patients. We compared SARS-CoV-2 positivity in ACM users to retrospective data collected from 268 untreated HCWs at the same hospital. Eligible participants received an aerosolized combination of 21.3 mg/ml glutathione and 8.7 mg/ml inosine in 107 mM potassium solution for 14 days. The main outcome was the frequency of laboratory-confirmed SARS-CoV-2 cases, defined as individuals with positive genetic or immunological tests within 28 days of the study period.ResultsSARS-CoV-2 was detected in 2 ACM users (2, 95% CI: 0.3 to 7.1%), which was significantly less than the incidence in nonusers, at 24 (9, 95% CI: 5.8 to 13.0%; P = 0.02). During the PrEP period, solicited adverse events occurred in five participants; all were mild and transient reactions.ConclusionsOur findings might be used either to prevent SARS-CoV-2 infection or to support ongoing and new research into more effective treatments for COVID-19.Trial registrationISRCTN, ISRCTN34160010. Registered 14 September 2020 - Retrospectively registered.

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