Pathogenesis based pre exposure prophylaxis associated with low risk of SARS CoV 2 infection in healthcare workers at a designated Covid 19 hospital

At present, no agents are known to be effective in 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, using a low dose aerosolized combination of glutathione, inosine and potassium. From June 1 to July 10, 2020, we conducted a low-intervention open-label single-centre study to evaluate safety and efficacy of pre-exposure prophylaxis (PrEP) with the aerosolized combination medications (ACM) on SARS-CoV-2 incidence in 99 healthcare workers (HCWs) at a hospital that was designated to treat Covid-19 patients. We also retrospectively compared SARS-CoV-2 incidence in the ACM users to that in 268 untreated HCWs at the same hospital. Eligible participants received an aerosolized combination of 21.3 mg/ml glutathione, 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. During the PrEP period, solicited adverse events occurred in five participants; all were mild and transient reactions. SARS-CoV-2 was detected in 2 ACM users (2%, 95% CI: 0.3% to 7.1%), which was significantly less than the incidence in 24 nonusers (9%, 95% CI: 5.8% to 13.0%; P = 0.02). Our 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. The study was registered with rosrid.ru, AAAA-A20-120061690058-2, and isrctn.com, [ISRCTN34160010][1]. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN34160010. The study was propsectively registered with rosrid.ru in accordance with national regulations. ### Funding Statement No external funding was received. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was reviewed and approved by the Local Ethics Committee at North-Western State Medical University named after I.I. Mechnikov of the Ministry of Health of Russian Federation, St. Petersburg, Russia (4/27-05-2020) All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes The datasets generated during and/or analysed during the study are available from the corresponding author on reasonable request. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN34160010