Within this context it is important to point out that in vitro data indicate efficacy of azelastine against various SARS-CoV-2 variants tested10. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. ISSN 0028-0836 (print). Assignment of the treatment with the investigational medicinal product in the different doses vs. placebo to each treatment number was performed in a centrally conducted, computer-generated 1:1:1 randomization procedure. Evaluation of AUC values (reflecting baseline adjusted decreases of viral load over 11days) showed that the 0.1% azelastine group exhibited a greater AUC value of 24.1413.12 (referring to greater decrease) compared to the placebo group with an AUC value of 18.894.70 (p=0.007, Fig. Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of H.G., M.S., and F.K. Lancet Infect. As a sensitivity analysis based on the SARS-CoV-2 E gene PCR tended to show overall the same effects, PCR results of the E gene are shown in the supplementary material (supplementary Table S3 and S4). Similarly, when given 2 or 4 hours after SARS-CoV-2 had already infected the epithelium, TriSb92 was linked to a complete lack of the virus's RNA in the lungs. A phase 1 study for IGM-6268 is still taking place, and it's expected to be finished by December 2022. From hydroxychloroquine and veterinarian doses of the antiparasitic drug ivermectin, questionableand potentially harmfultreatments for COVID-19 have circulated the internet. Unlike a COVID vaccine that boosts a persons immune system as protection, the antiviral nasal spray works more directly by blocking the virus, acting as a "biological mask in the nasal cavity," according to, One of these smaller antibodies is being developed, to develop synthetic nanobodies; and in a third case, researchers isolated nanobodies. Categorical data were described by absolute frequencies and percentage of valid cases. ACS Med. J. Infect. Patients of the current trial were eligible upon positive PCR test results, and if enrolled no later than 48h after swab sampling. The independent 25 variable was the nasal carriage of Bacillus species. AB is employed at Ursatec GmbH, supplier of primary packing materials to Ursapharm. Since viral levels during early infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) tend to be highest in the nose and nasopharynx 1, a nasal spray with an active substance . Molecular docking and dynamics simulation of FDA approved drugs with the main protease from 2019 novel coronavirus. . If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. A study led by an expert from The University of Western Australia has found a virus-killing nasal spray could be effective in reducing the spread of COVID-19. 4). It has been suggested that azelastine can inhibit the entry of the SARS-CoV-2 into the nasal mucosa by binding to the ACE2 receptor and also act via binding to the main protease of SARS-CoV-2 and to the host cells sigma-1 receptor, therewith facilitating both viral entry and replication-inhibiting effects6,9. https://doi.org/10.1007/s11224-020-01605-w (2020). Of note, the known bitter taste of azelastine was only negatively reported by a single patient, and compliance between treatment groups was comparable (meanSD: 97 0.129.7% compliance), thus indicating that the taste did not negatively influence treatment adherence. ISSN 2045-2322 (online). PM, MF, DG, CS and BS are employed at URSAPHARM Arzneimittel GmbH. Researchers have looked for ways to prevent SARS-CoV-2 infection that the virus cant learn to dodge or evade by mutating. H.S. Generally, treatment with azelastine appeared safe in SARS-CoV-2 positive patients: no serious adverse events were reported in the current study, and the number of adverse events was comparable between groups. https://doi.org/10.1016/s1473-3099(20)30483-7 (2020). Michel, J. et al. PDF Effect of nasal carriage of Bacillus species on COVID-19 severity: A These devices release a low-velocity aerosol mist that can be slowly inhaled over a longer period of time than metered dose and dry powder inhalers. At the end of the study (day 60), all except one single patient (placebo group) showed a score of 0. Identification of antiviral antihistamines for COVID-19 repurposing. How nasal-spray vaccines could change the pandemic, How much virus does a person with COVID exhale? Google Scholar. Google Scholar. The independent 25 variable was the nasal carriage of Bacillus species. Viral load and disease severity in COVID-19. Drug Resist. The availability of a self-administrable nasal spray reducing subsequent viral transmission would have great impacts for the community as correlations between SARS-CoV-2 viral load and infectiousness have been shown23. It should be noted that the SARS-CoV-2 alpha variant (B.1.1.7) was the dominant variant in Germany during the enrolment phase of the current study16. Objectives: The Hungarian vaccination campaign was conducted with five different vaccines during the third wave of the coronavirus disease 2019 (COVID-19) pandemic in 2021. Google Scholar. The viral load reduction of the ORF 1a/b gene from baseline to day 11 was log10 5.042.05 in the 0.1% azelastine group, log10 4.391.74 in the 0.02% azelastine and log10 4.151.34 in the placebo group. Vitiello, A., Ferrara, F., Troiano, V. & La Porta, R. COVID-19 vaccines and decreased transmission of SARS-CoV-2. Boots Dual Defence Nasal Spray is used to dampen the symptoms of cold and flu. Because N-0385 was suitable for use as a nasal spray, researchers used a mouse model that develops severe COVID-19 and gave the mice either N-0385 or control doses of saline in their noses. By submitting a comment you agree to abide by our Terms and Community Guidelines. Jean, F. (2022). Ninety SARS-CoV-2 positive patients were randomized into 3 groups receiving placebo, 0.02% or 0.1% azelastine nasal spray for 11days, during which viral loads were assessed by quantitative PCR. Of note, in vitro tests carried out prior to the current study did not indicate any interaction between the study products and the PCR reaction (see supplementary PCR data). Early intervention with azelastine nasal sprays reduces viral load in SARS-CoV-2 infected patients. Boots Dual Defence Nasal Spray 20ml - Boots Pharmacol. The surface of SARS-CoV-2, the virus that causes COVID-19, is covered with spike proteins. was responsible for the patient disposition. Importantly, the AUC analysis depicting the viral load decrease based on the detection of the ORF 1a/b gene over the 11-day treatment period showed a significantly greater reduction of virus load in the 0.1% azelastine group compared to placebo. The reduction in the symptom score was clinically relevant for all three groups. Recent publications indicating that in vitro infectivity correlates with high virus concentrations (Ct25) in nasal swabs28,29,30 underline the importance of analysis of this subset population. Antiviral efficacy was observed at an EC50 of~6M, which is an approximately 400-fold lower concentration compared to commercially available azelastine nasal sprays. The reduction of virus load (reflected by decreases of ORF 1a/b gene copy numbers) from baseline to the end of treatment (day 11) was log10 4.452.26 in the 0.1% azelastine group, log10 4.122.01 in the 0.02% azelastine and log10 3.821.61 in the placebo group (Fig. A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic. Review of azelastine nasal spray in the treatment of allergic and non-allergic rhinitis. Levine-Tiefenbrun, M. et al. When given in advance, none of the treated mice had SARS-CoV-2 RNA in their lungs, while untreated mice in the comparison group had abundant levels. E.N., V.S., G.N., R.K., A.B., M.F. Samples were processed on the day of receipt at the central processing laboratory (Institute of Virology, University Hospital Cologne, Cologne, Germany) by vortexing and aliquoting the viral transport medium and stored at80C until analysis. and JavaScript. The median/mean viral load value (ORF 1a/b gene) of the ITT analysis set at enrolment was log10 7.23/6.851.31 cp/mL (approximately 7 million viral copies per mL, the highest values being~540 million cp/mL). Sign up for the Nature Briefing newsletter what matters in science, free to your inbox daily. reported that a low pH hypromellose nasal powder spray containing common components of nasal sprays could reduce SARS-CoV-2 infection rates19. Pawar, R. D. et al. Symptoms were analyzed as single symptom scores, and as the total symptom score (TSS) reflecting the sum of all 20 single symptoms and presence/absence of fever (reaching a minimum value of 20 and maximum value of 103). To infect a cell, the virus tricks several of that cells proteins, including one called TMPRSS2, to gain entry. Within the subgroup of patients with baseline Ct values below 25, a similar progression of viral load data was observed (Fig. Nasal spray that protects against COVID-19 is also effective against the common cold . Pharmaceutics 14, 2502. https://doi.org/10.3390/pharmaceutics14112502 (2022). By Dr. Ramya Dwivedi, Ph.D. Jul 19 2021. The aim of our study was to support the preclinical evidence for azelastines antiviral activity in patients tested positive for SARS-CoV-2. PDF Effect of nasal carriage of Bacillus species on COVID-19 severity: A Furthermore, three independent groups predicted interaction of azelastine hydrochloride with the main protease of SARS-CoV-2: main protease (Mpro) or 3C-like cysteine protease (3CLpro)7,8,9. Article Pharmacother. Monoclonal antibodies can block SARS-CoV-2 from . Since the start of the COVID-19 pandemic, its treatment via the nasal route has been studied for a range of drugs17. FH is the CEO of URSAPHARM Arzneimittel GmbH. Future studies will help understanding the impact of azelastine hydrochloride in treating SARS-CoV-2 infected patients. A study of frontline workers is looking into how a Boots nasal spray could prevent Covid-19. It also appears to .