Overall, the current results are encouraging; however, further studies should be carried out to strengthen the findings, and treatment should be extended to other age and risk groups and cover individuals with different levels of symptom severity. 20, e192e197. Watts, A. M., Cripps, A. W., West, N. P. & Cox, A. J. Modulation of allergic inflammation in the nasal mucosa of allergic rhinitis sufferers with topical pharmaceutical agents. 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. Absolute changes in viral copy numbers (log10 cp/mL) from baseline (day 1) over time based on the ORF 1a/b gene (ITT analysis set). On days 1, 5, 8 and 11, patients completed the standardized SF-36 questionnaire of quality of life. contracts here. To obtain Reznikov et al. the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in How nasal-spray vaccines could change the pandemic, How much virus does a person with COVID exhale? Pediatr. You are using a browser version with limited support for CSS. Article 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. But the spike protein may mutate to evade immune response. Ethics approval was granted by the Ethics Committee of the Faculty of Medicine of Cologne University on the 10th of February 2021. 2005 - 2023 WebMD LLC, an Internet Brands company. was the principal investigator responsible for the conduct of the study, M.G. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiological . First report on a double-blind placebo-controlled phase II clinical trial. 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). 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 . Smell retraining therapy (SRT) is a treatment for loss of smell, also referred to as hyposmia or anosmia. Will there be a COVID winter wave? Lancet Infect. Boots Dual Defence Nasal Spray is used to dampen the symptoms of cold and flu. In addition, intervals between swab sampling were short and the overall number of performed PCR tests was high to allow a very close determination of the viral clearance. Researchers are developing coronavirus vaccines that will be sprayed up the nose. 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. https://doi.org/10.1016/s1473-3099(20)30483-7 (2020). Three-group comparisons were analysed with KruskalWallis test. AB is employed at Ursatec GmbH, supplier of primary packing materials to Ursapharm. Trial registration: The study was registered in the German Clinical Trial Register (DRKS-ID: DRKS00024520; Date of Registration in DRKS: 12/02/2021). Allergy Asthma Immunol. 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. Virol. 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. Identification of 14 known drugs as inhibitors of the main protease of SARS-CoV-2. New research has answers, COVID's future: mini-waves rather than seasonal surges, Are repeat COVID infections dangerous? Symptoms were evaluated on a 5-point scale from 1=symptom absent or present very weakly to 5=symptom present very strongly: anosmia, ageusia, cough, sore throat, shortness of breath, coryza, general weakness, headache, aching limb, loss of appetite, pneumonia, nausea, abdominal pain, vomiting, diarrhea, conjunctivitis, rash, lymph node swelling, apathy, somnolence. was the deputy investigator. 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. Loading Twitter content. The overall AUC of the Azelastine 0.1% group (red area) was significantly greater than that of placebo (green area), p=0.007. E.N., V.S., G.N., R.K., A.B., M.F. 17(2), 19. These latch onto ACE2 receptors on human cells, allowing the virus to enter and infect the cells. Correspondence to Internet Explorer). 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. Pharmaceutics 14, 2059. https://doi.org/10.3390/pharmaceutics14102059 (2022). By application of a novel computational approach based on Shannon entropy homology, Konrat et al. Liu, L. et al. Investigators assessed patients status throughout the trial including safety follow-ups (days 16 and 60). https://doi.org/10.1056/NEJMc2027040 (2021). Boots Dual Defence Nasal Spray is used to dampen the symptoms of cold and flu. Biochem. 5) Of note, these differences were not statistically significant (p=0.112). Whether the current data can be extrapolated to other SARS-CoV-2 variants needs to be investigated. Ghahremanpour, M. M. et al. At the end of the study (day 60), all except one single patient (placebo group) showed a score of 0. Xlear have developed and patented a xylitol containing nasal spray for the treatment of upper-respiratory tract infections. Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults. Kim, M.-C. et al. 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. Virological assessment of hospitalized patients with COVID-2019. Viral load and disease severity in COVID-19. J. Med. Viruses 13, 895. https://doi.org/10.3390/v13050895 (2021). Kalle Saksela, MD, PhD, virologist, University of Helsinki, Nature Communications: Intranasal trimeric sherpabody inhibits SARS-CoV-2 including recent immunoevasive Omicron subvariants.. Head Neck Surg. The reduction in the symptom score was clinically relevant for all three groups. A., Dion, S. P., Buchholz, D. W., Imbiakha, B., Olmstead, A. D., Jager, M., Dsilets, A., Gao, G., Martins, M., Vandal, T., Thompson, C. A. H., Chin, A., Rees, W. D., Steiner, T., Nabi, I. R., Marsault, E., Sahler, J., Diel, D. G., . 03:08. drafted the manuscript. Pharmacother. De Vries, R. D. et al. https://doi.org/10.1016/s2213-2600(20)30354-4 (2020). In animal models, by directly inactivating the virus,TriSb92 offers immediate and robust protection against coronavirus infection and severe COVID, said Anna R. Mkel, PhD, lead author of the study and a senior scientist in the Department of Virology at the University of Helsinki in Finland., Thestudy was published online March 24 in Nature Communications.. A nasal and mouth spray called "IGM-6268" is in the early stages of clinical trials. . 62, 50937, Cologne, Germany, CEBINA GmbH, Karl-Farkas-Gasse 22, 1030, Vienna, Austria, Eszter Nagy,Valria Szijrt&Gbor Nagy, Department of Structural and Computational Biology, Max F. Perutz Laboratories, University of Vienna, Dr.-Bohr-Gasse 9, 1030, Vienna, Austria, Laboratory of Experimental Immunology, Institute of Virology, Faculty of Medicine and University Hospital, University of Cologne, Kerpener Str. Antiviral activity was subsequently verified in cell culture. 83, 237279. Front. 19(10), 16. Z. Gesundheitswissenschaften J. Google Scholar. https://doi.org/10.1007/s11739-021-02786-w (2021). JAMA 325, 632644. Applied treatment regimens aimed to explore differences regarding viral carriage upon treatment with azelastine compared to placebo. [1] Nasal delivery of an IgM offers broad protection from SARS-CoV-2 variants. 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. . Med. Subgroups were analysed exploratorily (e.g., subgroups regarding gender, age, symptom severity, etc.). The sprays generally require multiple doses per day, whereas a single dose of a nasal vaccine may protect for months, he said. Now, researchers at Swansea University will test it against Covid-19 Now, researchers at Swansea University. June 10, 2022 at 2:00 pm. Clinical efficacy of nitric oxide nasal spray (NONS) for the treatment of mild COVID-19 infection. Google Scholar. Lee, K. (2022, April 27). Monoclonal antibodies can block SARS-CoV-2 from . Scientific Reports (Sci Rep) ADS Nature, 10.1038/s41586-022-04661-w. Advance online publication. Shapira, T., Monreal, I. Article Google Scholar. Cornell research team to develop COVID-19 nose spray treatment. 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. Google Scholar. About 388 participants were included in the study Following translocation from nucleus to the endoplasmic reticulum (ER), the sigma-1 receptor (among other factors) plays a role in viral replication. We acknowledge support for the Article Processing Charge from the DFG (German Research Foundation, 491454339). Now, researchers at Swansea University will test Boots' Dual Defence Nasal Spray, which costs 5.99 for 20ml, against Covid-19. Open Access funding enabled and organized by Projekt DEAL. Nature 581, 465469. 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. Pharmacol. https://doi.org/10.1021/acsmedchemlett.0c00521 (2020). 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. JPK and CL have received grants from the sponsor URSAPHARM Arzneimittel GmbH for performing this trial. Since the start of the COVID-19 pandemic, its treatment via the nasal route has been studied for a range of drugs17. Quality of life was assessed with the SF-36 questionnaire as no COVID-19 specific patient-reported outcome measures were available at the time of study. A Boots nasal spray for cold and flu has shown positive results during testing to see if it could help tackle coronavirus infections. Instructions for storing, preparing, and administering the study treatment will be provided to participants. Google Scholar. Expert. Lancet Respir. The first administration of the nasal spray was carried out in the presence of the investigator; products were subsequently self-administered for 11days (treatment phase). Both descriptive and exploratory statistics were performed. Rep. 117 https://doi.org/10.1007/s43440-023-00463-7. Since the start of the Coronavirus Disease 2019 (COVID-19) pandemic, several independent research groups revealed azelastines potential as a promising candidate for drug repurposing to reduce SARS-CoV-2 viral load and infection rates5,6,7,8,9,10. Cegolon, L. et al. 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. Of note, pharmacometric analyses of our data indicate that more frequent applications of the nasal spray may be more appropriate for efficient treatment35. Now, researchers at Swansea University will test it against Covid-19. https://doi.org/10.1001/jamaoto.2020.5490 (2021). 59.3% (0.1% azelastine treatment), 50.0% (0.02% azelastine treatment) and 80.8% (placebo treatment) of patients assessed the overall tolerability of the treatment as very good, which mirrored the tolerability judgement of the investigators, which was assessed as very good for 59.3% (0.1% azelastine treatment), 50.0% (0.02% azelastine treatment) and 80.8% (placebo treatment) of patients. https://doi.org/10.1001/jama.2021.0202 (2021). EN, VS and GN are shareholders in CEBINA GmbH, RK and EN are inventors on related patent applications. A., Dion, S. P., Buchholz, D. W., Imbiakha, B., Olmstead, A. D., Jager, M., Dsilets, A., Gao, G., Martins, M., Vandal, T., Thompson, C. A. H., Chin, A., Rees, W. D., Steiner, T., Nabi, I. R., Marsault, E., Sahler, J., Diel, D. G., . https://doi.org/10.1016/s1081-1206(10)63465-5 (1996). Shmuel, K., Dalia, M., Tair, L. & Yaakov, N. Low pH Hypromellose (Taffix) nasal powder spray could reduce SARS-CoV-2 infection rate post mass-gathering event at a highly endemic community: An observational prospective open label user survey. Bearing in mind the low number of participants in the current proof-of-concept study, the results still build a promising foundation for a currently running phase III study, during which effects of azelastine nasal spray on symptom severity and progression to severe COVID-19 disease are investigated in a greater patient population. During the throes of the COVID-19 pandemic, Anne Moscona didnt feel safe going to a restaurant or catching a flight. Nasal antiviral blocks SARS-CoV-2 infection in mice, Finding Effective Treatments for SARS-CoV-2 Variants, Understanding the Range of Reactions to SARS-CoV-2, Lee, K. (2022, April 27). Prevention is the best medicine, and COVID-19 vaccines block most SARS-CoV-2 infections. Marshall, J. C. A minimal common outcome measure set for COVID-19 clinical research. This is exemplified by the emergence of the highly immune evasive omicron variant that is resistant to many monoclonal antibodies authorized for clinical use34. Ghahremanpour et al. Comirnaty is the FDA-approved monovalent COVID-19 (coronavirus 2019) vaccine made by Pfizer for BioNTech. The preventive application of a hydroxypropyl methyl cellulose nasal spray showed promising results in an observational survey, indicating that it may reduce SARS-CoV-2 infection rates19. SARS-CoV-2 viral load predicts COVID-19 mortality. Even in cases where the antiviral does not prevent coronavirus infection, the treatment could slow infection. Interestingly, significantly greater decrease in viral load was shown on day 4 of treatment in patients with high viral burden (Ct<25) treated with 0.1% azelastine compared to placebo, indicating that azelastine treatment may be advantageous for this patient population, particularly at an early timepoint of infection. Center for Molecular Medicine Cologne (CMMC), Faculty of Medicine and University Hospital, University of Cologne, Kerpener Str. Our study results provide the first human data showing that azelastine hydrochloride nasal spray used in a 0.1% concentration may be effective in accelerating the reduction of virus load in the nasal cavity and improving symptoms reported by COVID-19 patients. 2 and supplementary Table S2). Data on virus variants was available for 59 patients and 54 (92%) of those carried the alpha (B.1.1.7) variant. Soft mist inhalers are propellant-free devices that are slightly larger than conventional metered dose inhalers. Med. performed the statistical analysis. Within the subgroup of patients with baseline Ct values below 25, a similar progression of viral load data was observed (Fig. and JavaScript. To infect a cell, the virus tricks several of that cells proteins, including one called TMPRSS2, to gain entry. For hygiene reasons, it is preferable not to share the same nasal spray with other people. Inflammopharmacology 29(5), 14. SARS-CoV-2 RNA levels in nasopharyngeal swabs were determined by quantitative RT-PCR using the cobas SARS-CoV-2 Test on the cobas 6800 system (Roche Diagnostic, Mannheim, Germany). Jean, F. (2022). 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. https://doi.org/10.1517/14656566.8.5.701 (2007). The sample size calculation was based on the expected reduction of virus load during the treatment considering 3 treatment arms.
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