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
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Abstract
Background
At 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.
Methods
From 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.
Results
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 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.
Conclusions
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.
Trial registration
ISRCTN, ISRCTN34160010 . Registered 14 September 2020 - Retrospectively registered.
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SciScore for 10.1101/2020.09.25.20199562: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The study was reviewed and approved by the Local Ethics Committee at NWSMU (4/27-05-2020).
Consent: Informed consent was obtained from all participants of the study.Randomization Study procedures: From the full staff of HCWs at the hospital, 99 volunteers were assigned to a study condition among 100 HCWs who were randomly recruited to participate in the study by members of the study team at the hospital from June 1 to June 12, 2020 (Figure 1). Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Serum antibodies were assayed using two diagnostic kits approved in Russia for … SciScore for 10.1101/2020.09.25.20199562: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The study was reviewed and approved by the Local Ethics Committee at NWSMU (4/27-05-2020).
Consent: Informed consent was obtained from all participants of the study.Randomization Study procedures: From the full staff of HCWs at the hospital, 99 volunteers were assigned to a study condition among 100 HCWs who were randomly recruited to participate in the study by members of the study team at the hospital from June 1 to June 12, 2020 (Figure 1). Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Serum antibodies were assayed using two diagnostic kits approved in Russia for qualitative detection of immunoglobulins against SARS-CoV-2 in human plasma, per the manufacturers’ instructions: SARS-CoV-2-IgM-IFA BEST (Vector-Best, Novosibirsk, Russia) and SARS-CoV-2–IgG (Lytech, Moscow, Russia). Vector-Best, Novosibirsk, Russia) and SARS-CoV-2–IgG (Lytech, Moscow, Russia).suggested: NoneSoftware and Algorithms Sentences Resources The analysis was conducted using SAS software. SASsuggested: (SASqPCR, RRID:SCR_003056)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title ISRCTN34160010 NA NA Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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