https://doi.org/10.1016/j.bbrc.2020.11.095 (2021). Since the start of the COVID-19 pandemic, its treatment via the nasal route has been studied for a range of drugs17. The product targets a stable site on the spike protein of the virus that is not known to mutate. https://doi.org/10.1016/j.jinf.2021.05.009 (2021). Suitable for SRT was originally developed in 2009 by Dr. Thomas Hummel at the University of Dresden. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. Our study population was characterized by an initial mean viral load of log10 6.851.31cp/mL, which was higher than more recently reported SARS-CoV-2 viral load values26. Ethics approval was granted by the Ethics Committee of the Faculty of Medicine of Cologne University on the 10th of February 2021. Inhibition of leukotriene synthesis by azelastine. Bullinger, M., Kirchberger, I. Early negativization of SARS-CoV-2 infection by nasal spray of seawater plus additives: The RENAISSANCE open-label controlled clinical trial. The data that support the findings of this study are available from URSAPHARM Arzneimittel GmbH but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Molecular docking and dynamics simulation of FDA approved drugs with the main protease from 2019 novel coronavirus. It also appears to . Patient disposition. Inflammopharmacology 29(5), 14. Those compounds were tested in human lung and colon cells that were then exposed to SARS-CoV-2. Assuming a pooled standard deviation of =3 units, a two-sided =0.05 and a power of 90%, a sample size of 23 patients per treatment group was calculated. Now, researchers at Swansea University will test it against Covid-19. . IGM-6268. J. Infect. It would be desirable to extend the investigation of azelastine nasal spray as potential antiviral treatment with in vitro culture experiments. Will there be a COVID winter wave? Of note, pharmacometric analyses of our data indicate that more frequent applications of the nasal spray may be more appropriate for efficient treatment35. Patients were assigned a treatment number in an ascending mode according to their chronological order of inclusion. Acta Pharmacol. Soft mist inhalers are propellant-free devices that are slightly larger than conventional metered dose inhalers. Guenezan, J. et al. TriSb92 isone of multiple nasal spray approaches but unlikely to be as durable as effective nasal vaccines, saidEricTopol, MD, a professor of molecular medicine and executive vice president of Scripps Research in La Jolla, CA. Nature, 10.1038/s41586-022-04661-w. Advance online publication. Comparably, differences in reduction of log10 viral load (cp/mL) in our study were0.63 (ORF 1a/b gene) comparing treatment with 0.1% azelastine to placebo. https://doi.org/10.1038/s41586-022-04661-w. Read stories about the efforts underway to prevent, detect, and treat COVID-19 and its effects on our health. 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). Both descriptive and exploratory statistics were performed. In the meantime, to ensure continued support, we are displaying the site without styles 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. We would like to thank Prof. G.A. For pairwise comparisons between treatment groups, Mann Whitney U test was performed, and significance levels were adjusted to p<0.0167 based on the Bonferroni correction. It would be desirable to study azelastine treatment in a greater COVID-19 population to get further insights on azelastines effects on individual symptoms and to determine its potential on long-term symptoms. 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). JPK and CL have received grants from the sponsor URSAPHARM Arzneimittel GmbH for performing this trial. To evaluate the total load during the study, AUC was calculated using a linear equation. 03:08. This was a prospective, randomized, double-blind, placebo-controlled dose-finding proof-of-concept study, in which azelastine nasal spray was used in 2 doses: the commercially available concentration of 0.1% and a fivefold lower concentration of 0.02%. B.R. The trial medication (placebo nasal spray, 0.02% azelastine nasal spray or 0.1% azelastine nasal spray (the latter being identically composed as the commercial anti-allergic product Pollival) was manufactured at URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany). The patient status was assessed at V1V7 and at V9 by the investigators with a 11-category ordinal score proposed by the WHO11. To obtain Other evidence of viral infection showed similar differences between treated and untreated mice in the protective lining of cells called the, inside the nose, nasal mucosa, and airways., : Intranasal trimeric sherpabody inhibits SARS-CoV-2 including recent immunoevasive Omicron subvariants.. volume13, Articlenumber:6839 (2023) 4). Cornell research team to develop COVID-19 nose spray treatment. Google Scholar. All rights reserved. Thus, antibody therapy (bamlanivimab and etesevimab) in positively tested, non-hospitalized patients demonstrated that treatment resulted in decreased SARS-CoV-2 viral load by log100.57 on day 11, which was significantly greater compared to placebo (p=0.01)33. Get the most important science stories of the day, free in your inbox. Med. Sign up for the Nature Briefing newsletter what matters in science, free to your inbox daily. https://doi.org/10.1089/088318703322751327 (2004). Reznikov et al. It was assumed that all treatment groups present identical baseline virus load at enrolment with a mean value of 5.5 log10 copies/mL3 SD13,14. Nasal steroid sprays may reduce the severity of COVID-19, according to a new study. The higher viral load value may be explained with the dominance of the alpha (B.1.1.7) SARS-CoV-2 variant during the enrolment phase (Spring 2021, Germany16), which is known to infect the human nasal mucosa more efficiently than the wild-type and has been associated with higher viral load13,14. drafted the manuscript. https://cornellsun.com/2022/04/27/cornell-research-team-to-develop-covid-19-nose-spray-treatment/, https://doi.org/10.1038/s41586-022-04661-w, Antiviral Nasal Spray Shows Promise Fighting COVID-19. Even in cases where the antiviral does not prevent coronavirus infection, the treatment could slow infection. PubMed https://doi.org/10.1001/jama.2021.0202 (2021). Reznikov, L. R. et al. Resource-efficient internally controlled in-house real-time PCR detection of SARS-CoV-2. Moreover, this group showed that azelastine has the potential to inhibit SARS-CoV-2 cell entry by binding to the angiotensin-converting enzyme 2 (ACE2) receptor and to inhibit intracellular virus replication through binding to the sigma-1 receptor6. Although no significant differences between groups regarding the total symptom score was shown, it may be speculated that the 0.1% azelastine spray may have positive influences on single symptoms such as shortness of breath, which was improved significantly greater in this treatment group compared to placebo at early time points of infection. Cornell Daily Sun. Instructions for storing, preparing, and administering the study treatment will be provided to participants. Future studies will help understanding the impact of azelastine hydrochloride in treating SARS-CoV-2 infected patients. At the end of the study, patients and investigators assessed the overall tolerability and efficacy of the treatment as very good (3), good (2), moderate (1) or poor (0). . One puff of the respective nasal spray was applied per nostril, 3 times a day (morning, midday, evening). The trial protocol and the data are however available from the authors upon reasonable request and with permission of URSAPHARM Arzneimittel GmbH. the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Infect. All this made her work personal: for the past decade, Moscona, a molecular virologist, had been hunting for compounds that could stop viruses in their tracks, before the pathogens infect even a single cell in a persons body. The hope is the vaccines will build immunity in one spot the coronavirus often invades . China and India approve nasal COVID vaccines are they a game changer? A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic. About 388 participants were included in the study For calibration purposes of quantitative assessments, reference samples were included with each PCR run. CAS R.M., S.M.S., S.A. and P.M. designed the study protocol. Health-related quality of life in patients with COVID-19; international development of a patient-reported outcome measure. Nineteen of those were common COVID-19 symptoms (shortness of breath [n=4], loss of smell [n=4], loss of taste [n=3], [muscle] weakness [n=2], tiredness/exhaustion [n=2], muscle ache, concentration impaired, headache, and cough). Ther. The liquid contains NO at 0.11 ppm*hour, which acts as a viricidal agent. The Impact of Opioid Use Disorder Services on Overdose Deaths, Access to telehealth and medications for opioid use disorder during the pandemic reduced drug overdose deaths, Bivalent Boosters Offer Better Protection Against Omicron, Updated boosters are more effective at preventing severe COVID-19 from the most common SARS-CoV-2 variant, Page last updated: Whether the current data can be extrapolated to other SARS-CoV-2 variants needs to be investigated. The investigators judged the efficacy as good or very good in 74.1% (0.1% azelastine treatment), 82.1% (0.02% azelastine treatment) and 73.1% (placebo treatment) of treated patients. Additionally, 0.02% azelastine nasal spray and 0.1% azelastine nasal spray were formulated by the addition of 0.2mg/mL or 1mg/mL azelastine hydrochloride, respectively. Investigators assessed patients status throughout the trial including safety follow-ups (days 16 and 60). A summary of study activities is displayed in Table 2. Virol. Hamasaki, Y. et al. 20, e192e197. A closer look at single symptoms confirmed moderate expression of symptoms (supplementary Figure S1) and the general decrease of symptoms over time (supplementary Figure S2). The nasal sprays for COVID have been shown to surpass existing antibody treatments in engineered mice and have been effective in treating and preventing not only standard COVID-19 infections. All methods were carried out in accordance with relevant guidelines, and the principles of Good Clinical Practice and the Declaration of Helsinki were adhered to. Nature 605, 340348 (2022). C.A. Anna R. Mkel, PhD, senior scientist, Department of Virology, University of Helsinki, Finland. Review of azelastine nasal spray in the treatment of allergic and non-allergic rhinitis. As expected, a continuous decrease in the mean virus load was observed in all study groups during the 11 treatment days. 27, 790792. https://doi.org/10.1517/14656566.8.5.701 (2007). Categorical data were described by absolute frequencies and percentage of valid cases. Both have the allure of being variant-proof, Topol added., Many laboratories are shifting from treatments using monoclonal antibodies to treatments using smaller antibody fragments called "nanobodies" because they are more cost-effective and are able to last longer in storage, Mkel and colleagues noted., Several of these nanobodies have shown promise against viruses in cell culture or animal models, including as an intranasal preventive treatment for SARS-CoV-2.. https://doi.org/10.1001/jamaoto.2020.5490 (2021). Pharmaceutics 14, 2502. https://doi.org/10.3390/pharmaceutics14112502 (2022). Boots Dual Defence Nasal Spray is used to dampen the symptoms of cold and flu. Allergy Asthma Immunol. ISSN 1476-4687 (online) Nat. Ghahremanpour, M. M. et al. 24 COVID-19 status classified as negative, asymptomatic, mild, or severe. . Correspondence to https://doi.org/10.1016/s2213-2600(20)30354-4 (2020). Other evidence of viral infection showed similar differences between treated and untreated mice in the protective lining of cells called theepithelium inside the nose, nasal mucosa, and airways.. The 0.02% azelastine group showed an AUC value of 22.6412.56, which was not significantly different from the placebo group (p=0.022, Fig. and showed they could neutralize the SARS-CoV-2 virus. When treated with N-0385, 70% of the mice survived and had little to no lung damage. Dings, C. et al. We acknowledge support for the Article Processing Charge from the DFG (German Research Foundation, 491454339). 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. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. HG, MS, and FK declare no conflict of interest. Winchester, S., John, S., Jabbar, K. & John, I. From hydroxychloroquine and veterinarian doses of the antiparasitic drug ivermectin, questionableand potentially harmfultreatments for COVID-19 have circulated the internet. JAMA Otolaryngol. 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. Receive 51 print issues and online access, Get just this article for as long as you need it, Prices may be subject to local taxes which are calculated during checkout, doi: https://doi.org/10.1038/d41586-022-03341-z. These latch onto ACE2 receptors on human cells, allowing the virus to enter and infect the cells. One study of about 400 health-care workers suggests a nasal spray may reduce the incidence of COVID-19 by up to 80 per cent. Bearing in mind that viral load might be a surrogate measure of infectiousness, those results are encouraging as they indicate that azelastine may be a promising candidate for preventing the spread of this disease. WebMD does not provide medical advice, diagnosis or treatment. Viral load and disease severity in COVID-19. And she wished she could feel confident that she could see her immunocompromised relatives without inadvertently spreading the novel coronavirus to them.

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