And she wished she could feel confident that she could see her immunocompromised relatives without inadvertently spreading the novel coronavirus to them. For quantification of SARS-CoV-2-RNA in copies/mL, a standard curve derived from a dilution series of a SARS-CoV-2 cell culture isolate in VTM and adjusted to Ct values obtained from two samples with defined SARS-CoV-2-RNA copy numbers (106 and 105 copies/mL; INSTAND e.V., Duesseldorf, Germany) was used. ADS Monoclonal antibodies can block SARS-CoV-2 from . All nasal sprays were composed of hypromellose, disodium edetate, citric acid, disodium phosphate dodecahydrate, sodium chloride and purified water. Open Access funding enabled and organized by Projekt DEAL. Lee, K. (2022, April 27). PubMedGoogle Scholar. The anti-histamine azelastine, identified by computational drug repurposing, inhibits infection by major variants of SARS-CoV-2 in cell cultures and reconstituted human nasal tissue. https://doi.org/10.1016/j.bbrc.2020.11.095 (2021). The current study was a randomized, parallel, double-blind, placebo-controlled trial. Outpatients visiting Corona test centres were informed about the possibility of participating in the trial. Pawar, R. D. et al. Anna R. Mkel, PhD, senior scientist, Department of Virology, University of Helsinki, Finland. However, a rinsing and diluting effect of the placebo formulation would have led to an underestimation of the effect of the use of the azelastine nasal spray. By application of a novel computational approach based on Shannon entropy homology, Konrat et al. PubMed Central COVID-19 vaccines teach the immune system to recognize a particular protein on SARS-CoV-2 that is known as the spike protein. PubMed D.G., C.S. In a study examining the effect of azelastine nasal spray on upper respiratory infections in children, it was found that the placebo group, receiving hypertonic saline solution (twice daily) also produced a favourable response compared to those receiving no treatment31. Antiviral activity was subsequently verified in cell culture. . 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. ICE-COVID, will investigate whether Dual Defence can either prevent Covid-19 infection or reduce . Samples of day 1 represent pre-treatment baseline samples. In a highly relevant and translational in vitro model using reconstituted human nasal tissue, a fivefold diluted commercially available azelastine nasal spray solution inhibited viral replication almost completely within 72h after SARS-CoV-2 infection10. Nature (Nature) and B.S. ITTintention to treat. Jean, F. (2022). Article MG, PA, HM and HAS declare no conflict of interest. Sign up for the Nature Briefing newsletter what matters in science, free to your inbox daily. Topol is also editor-in-chief of Medscape, WebMD's sister site for medical professionals. Biophys. Our study showed both strengths and limitations. The number of possibly and probably related adverse events was comparable between treatment groups (supplementary Table S6), and no safety concerns regarding the treatment regime were raised. Smell Retraining Therapy - ENT Health New research has answers, COVID's future: mini-waves rather than seasonal surges, Are repeat COVID infections dangerous? Will there be a COVID winter wave? https://doi.org/10.1056/NEJMc2027040 (2021). The reduction of the symptom score from baseline to day 11 was 8.389.42 in the 0.02% azelastine group and 11.129.45 in the placebo group. Hamasaki, Y. et al. Konrat, R. et al. The sample size calculation was based on the expected reduction of virus load during the treatment considering 3 treatment arms. JPK and CL have received grants from the sponsor URSAPHARM Arzneimittel GmbH for performing this trial. [1] Nasal delivery of an IgM offers broad protection from SARS-CoV-2 variants. Applied treatment regimens aimed to explore differences regarding viral carriage upon treatment with azelastine compared to placebo. Acta Pharmacol. Nationwide effectiveness of five SARS-CoV-2 vaccines in - PubMed Jain, R. & Mujwar, S. Repurposing metocurine as main protease inhibitor to develop novel antiviral therapy for COVID-19. 24 COVID-19 status classified as negative, asymptomatic, mild, or severe. Med. reviewed, edited and finalised the manuscript. 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. While PCR results in the placebo group turned negative only on day 11 of treatment, individual patients of the 0.1% azelastine group already showed negative PCR test results from day 2 on. Comirnaty may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19. The Coronavirus Immunotherapy Consortium identified new candidate drugs based on monoclonal antibodies in work funded by NIAID. drafted the manuscript. 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. . Preliminary results of the current study have been published as preprint15. Cornell Daily Sun. 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. Data on virus variants was available for 59 patients and 54 (92%) of those carried the alpha (B.1.1.7) variant. All tests were performed two-sided and the type 1 error () was set to 5%. 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. Nasopharyngeal swabs were obtained by investigators using nylon-flocked swabs (Biocomma; SW01E, flexible minitip, Biocomma, Shenzen, China). Identification of antiviral antihistamines for COVID-19 repurposing. Multinomial regression analysis was done to 26 determine the association between nasal carriage of Bacillus and COVID-19 severity after 27 adjusting for age, sex, and co-morbidity status. was the principal investigator responsible for the conduct of the study, M.G. 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. Studies into Xlear's antiviral effects on SARS . Nasal Sprays Could Protect You From Serious COVID-19 Illness KaplanMeier survival analyses with log-rank test were performed to display the occurrence of negative PCR test results upon treatment. Since azelastine has been shown to inhibit viral replication by 99.9% in Vero E6 cell culture and in reconstituted human nasal tissue cultures, it was assumed that a reduction of 3-log in virus load would be seen within 3days in actively treated patients, while no effect on virus load reduction would be seen in placebo treated patients. Rep. 117 https://doi.org/10.1007/s43440-023-00463-7. You are using a browser version with limited support for CSS. Of note, the mean viral load value showed small variability, thereby supporting the power of the current study. The most promising compound, N-0385, virtually stopped infection in its tracks. H.S. https://doi.org/10.1021/acsmedchemlett.0c00521 (2020). To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The WHO clinical progression scale progressively decreased in all treatment groups during the study. SRT was originally developed in 2009 by Dr. Thomas Hummel at the University of Dresden. Kim, M.-C. et al. 4). Of note, the decrease of viral load on day 4 was significantly greater in the 0.1% azelastine group (decrease by log10 1.901.03) compared to placebo (decrease by log10 1.050.70). The experimental drug works in mice, and researchers believe it may be effective in humans. ISSN 0028-0836 (print). Google Scholar. Inhibition of SARS-CoV-2 by bentonite-based nasal spray. Front. Boots Dual Defence Nasal Spray is used to dampen the symptoms of cold and flu. Rev. A nasal and mouth spray called "IGM-6268" is in the early stages of clinical trials. JAMA 325, 632644. 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. 3). Now, researchers at Swansea University will test it against Covid-19. Nasal defence sprays Products such as Vicks First Defence nasal spray claim to trap and neutralise viruses in the nose before they have a chance to develop and spread. 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. Get the most important science stories of the day, free in your inbox. 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. Overall, none of the participating patients had clinically relevant increased values of body temperature (data not shown). Following translocation from nucleus to the endoplasmic reticulum (ER), the sigma-1 receptor (among other factors) plays a role in viral replication. To evaluate the total load during the study, AUC was calculated using a linear equation. Internet Explorer). Since viral levels during early infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) tend to be highest in the nose and nasopharynx1, a nasal spray with an active substance inhibiting virus entry and replication may stop or delay the progression of the disease to the lower respiratory system and reduce the transmission to uninfected individuals. & Ware, J. 2 and supplementary Table S2). N.W. By submitting a comment you agree to abide by our Terms and Community Guidelines. After treatment, virus load was reduced in all groups (p<0.0001) but was greater in the 0.1% group compared to placebo (p=0.007). Google Scholar. 19(10), 16. The trial protocol and the data are however available from the authors upon reasonable request and with permission of URSAPHARM Arzneimittel GmbH. Boots Dual Defence, which contains Carragelose, a patented version of iota-carrageenan, is already clinically proven to help shorten the duration and severity of cold and flu-like symptoms,[ii] and new in-vitro (test tube) laboratory study results suggest that Carragelose could also reduce the risk of an infection with SARS-CoV-2, the virus which 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. 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. 27, 790792. A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic. Negative PCR results appeared earlier and more frequently in the azelastine treated groups: being 18.52% and 21.43% in the 0.1% and 0.02% groups, respectively, compared to 0% for placebo on day 8. the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Many elderly people as well asindividuals who are immunodeficient for various reasons do not respond to vaccines, and are in the need of other protective measures, said Kalle Saksela, MD, PhD, senior author of the study and a virologist at the University of Helsinki. Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Even in cases where the antiviral does not prevent coronavirus infection, the treatment could slow infection. Intern. Asthma Allergy Immunol. March 31, 2023 An antiviral therapy in early development has the potential to prevent COVID-19 infections when given as a nasal spray as little as 4 hours before exposure. Inflammopharmacology 29(5), 14. When treated with N-0385, 70% of the mice survived and had little to no lung damage. Similarly, no clinically relevant differences regarding blood oxygen saturation values were detected between groups (data not shown).

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