Article 62, 50937, Cologne, Germany, German Center for Infection Research (DZIF) Location Bonn-Cologne, Kerpener Str. Review of azelastine nasal spray in the treatment of allergic and non-allergic rhinitis. Med. 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. Article 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. 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. CAS Article 19(10), 16. Samples of day 1 represent pre-treatment baseline samples. Simon, M. W. The efficacy of azelastine in the prophylaxis of acute upper respiratory tract infections. 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. CAS Topol is also editor-in-chief of Medscape, WebMD's sister site for medical professionals. drafted the manuscript. reported that a low pH hypromellose nasal powder spray containing common components of nasal sprays could reduce SARS-CoV-2 infection rates19. The reduction in virus load over the entire treatment period was clinically meaningful for all three groups (p<0.0001 for both genes). For calibration purposes of quantitative assessments, reference samples were included with each PCR run. Mitze, T. & Rode, J. Early-stage spatial disease surveillance of novel SARS-CoV-2 variants of concern in Germany with crowdsourced data. All tests were performed two-sided and the type 1 error () was set to 5%. Boots Dual Defence Nasal Spray is used to dampen the symptoms of cold and flu. Infect. These agents essentially trick the virus by changing the structure of the outside of cells, so they look like a virus has already fused to them. 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., . With the changing epidemiology of COVID-19 and its impact on our daily lives, there is still an unmet need of COVID-19 therapies treating early infections to prevent progression. Researchers began to work on compounds that stifle TMPRSS2s ability to interact with the viral protein. Short intervals of swab collection time points, particularly during early days of infection, and high number of PCR tests aimed to monitor SARS-CoV-2 viral loads as closely as possible, considering that only limited knowledge regarding details of viral clearance was publicly available at the time of the study development. Nat. Article This trial was conducted at the Department of Otorhinolaryngology, Head and Neck Surgery of the Faculty of Medicine of the University of Cologne, Germany. 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. Biochem. Reznikov, L. R. et al. the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in For hygiene reasons, it is preferable not to share the same nasal spray with other people. A summary of study activities is displayed in Table 2. Rev. A final safety follow-up and assessment of the patient status (WHO scale) by phone call was done on day 60 (V9) for all patients. Smell retraining therapy (SRT) is a treatment for loss of smell, also referred to as hyposmia or anosmia. *p=0.005 comparing the decrease of viral load on day 4 in the 0.1% azelastine group (log10 1.901.03) compared to placebo (log10 1.050.70; p=0.005). 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. Nasal sprays may be a promising first line of defense against SARS-CoV-2 infection. Vitiello, A., Ferrara, F., Troiano, V. & La Porta, R. COVID-19 vaccines and decreased transmission of SARS-CoV-2. Nat. New methods of fast-acting COVID-19 prevention are being researched to make it safer to be in large public gatherings like sporting events or concerts. Subgroups were analysed exploratorily (e.g., subgroups regarding gender, age, symptom severity, etc.). 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. Odhar, H. A. et al. Mice treated with just a single dose of N-0385 on the day they were infected had a high survival rate as well. At the end of the study (day 60), all except one single patient (placebo group) showed a score of 0. The sample size calculation was based on the expected reduction of virus load during the treatment considering 3 treatment arms. Slider with three articles shown per slide. Inflammopharmacology 29(5), 14. ICE-COVID a randomised, double blind, placebo-controlled phase III trial of the prophylactic efficacy of iota-carrageenan nasal and throat spray in preventing COVID-19 illness in at risk healthcare professionals. https://doi.org/10.1080/14787210.2021.1908127 (2021). Bioinformation 16, 236244. When the treatment course was shortened to four days, starting one day before infection, all 10 of the mice treated with N-0385. The researchers picked four compounds that worked at very low concentrations and did not negatively affect the host cells. 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. reviewed, edited and finalised the manuscript. 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. Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients. J.P.K. The surface of SARS-CoV-2, the virus that causes COVID-19, is covered with spike proteins. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Overall, none of the participating patients had clinically relevant increased values of body temperature (data not shown). Pharmacol. 42, 17. 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. the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in By blocking that access, compounds that target TMPRSS2 have the potential to be effective against both current and future variants. was the deputy investigator. PubMed It's being studied as a potential way to prevent mild to moderate cases of COVID-19. Outpatients visiting Corona test centres were informed about the possibility of participating in the trial. The efficacy of the treatment was judged as good or very good by 75.0% (0.1% azelastine treatment), 74.1% (0.02% azelastine treatment) and 50.0% (placebo treatment) of patients. Whether the current data can be extrapolated to other SARS-CoV-2 variants needs to be investigated. A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic. One misinformed. https://doi.org/10.1038/s41401-020-00556-6 (2020). JAMA 325, 632644. The azelastine 0.1% azelastine group displayed the greatest improvement of symptoms with 12.7410.74 mean score reduction. One of these smaller antibodies is being developedfrom llamas for example; another comes fromexperiments with yeast to develop synthetic nanobodies; and in a third case, researchers isolated nanobodiesfrom llamas and from mice and showed they could neutralize the SARS-CoV-2 virus. Researchers have looked for ways to prevent SARS-CoV-2 infection that the virus cant learn to dodge or evade by mutating. A research study at Swansea University is examining the efficacy of Boots Dual Defence - a 5.99 nasal spray containing seaweed - in preventing people becoming ill with Covid and reducing the . These nanobodies and TriSb92 target a specific part of the coronavirus spike protein called the receptor-binding domain (RBD). volume13, Articlenumber:6839 (2023) and JavaScript. Analyses were done on the entire data set (ITT) as well as on a subset population with high viral load defined by baseline Ct values below 25 (Ct<25). 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). HG, MS, and FK declare no conflict of interest. Google Scholar. Identification of antiviral antihistamines for COVID-19 repurposing. However, the overall small number of participants limits conclusions, and results should be interpreted with care. Cite this article. Lee, K. (2022, April 27). Klussmann, J.P., Grosheva, M., Meiser, P. et al. CAS Importantly, newly emerging virus variants have the potential to evade the immune response, thereby affecting the efficacy of specific therapies and underlining the importance of new treatment strategies. Viruses 12, 1384. https://doi.org/10.3390/v12121384 (2020). B.R. Additionally, safety follow-ups were performed at 2 time-points. Researchers at Swansea University will begin human trials this week following a successful study suggests the 5.99 remedy, Dual Defence, could help reduce infections thanks to its special ingredient - seaweed . 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). How nasal-spray vaccines could change the pandemic, How much virus does a person with COVID exhale? Chem. Performance of self-collected saliva testing compared with nasopharyngeal swab testing for the detection of SARS-CoV-2. 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.. Ralph Msges. Molecular docking and dynamics simulation of FDA approved drugs with the main protease from 2019 novel coronavirus. The study was termed CARVIN (referring to COVID-19: Azelastine nasal spray Reduces Virus-load In Nasal swabs). R.M., S.M.S., S.A. and P.M. designed the study protocol. Pharmaceutics 14, 2502. https://doi.org/10.3390/pharmaceutics14112502 (2022). The overall AUC of the Azelastine 0.1% group (red area) was significantly greater than that of placebo (green area), p=0.007. To obtain It would be desirable to extend the investigation of azelastine nasal spray as potential antiviral treatment with in vitro culture experiments. Postdoctoral fellowship in vascular biology at UT Southwestern, studying the endothelial basis of cardiometabolic disease. Google Scholar. 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. Will there be a COVID winter wave? Sin. 4). 8, e70. 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: ADS Sci. https://doi.org/10.1038/s41586-021-04388-0 (2022). The WHO clinical progression scale progressively decreased in all treatment groups during the study. Therefore, during the treatment phase, patients were required to document the severity of their COVID-19 related symptoms in an electronic diary on a daily basis. 90 patients were recruited between 09/03/2021 and 28/04/2021, constituting the safety analysis set. 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). Only one of the 20 mice given saline survived. 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. 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.. Indeed, the majority of the study subjects carried this variant. 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. N.W. During the throes of the COVID-19 pandemic, Anne Moscona didnt feel safe going to a restaurant or catching a flight. June 16, 2022, U.S. Department of Health and Human Services, The researchers first tried one dose a day for seven days, starting a day before SARS-CoV-2 infection. Thank you for visiting nature.com. We acknowledge support for the Article Processing Charge from the DFG (German Research Foundation, 491454339). While comparison of categorial variables between groups were performed by Chi square testing, continuous variables were compared using ANCOVA with the factors baseline, visit, and treatment group. ISSN 1476-4687 (online) 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 Patients aged 18 to 60years were eligible to participate if tested positive for SARS-CoV-2 in a Corona test centre by PCR test within 48h prior to inclusion and had to quarantine at home due to instructions of the local health authority. The aim of our study was to support the preclinical evidence for azelastines antiviral activity in patients tested positive for SARS-CoV-2. Now, researchers at Swansea University will test Boots' Dual Defence Nasal Spray, which costs 5.99 for 20ml, against Covid-19. The shown effects of azelastine nasal spray may thus be suggestive of azelastines potential as an antiviral treatment. 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. For clarity reason, only cp/mL values of the ORF 1a/b gene are shown in the main text of the manuscript. N. Engl. 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. Secondary endpoints included the assessment of symptoms, patient status (using a 11-category ordinal score as proposed by the WHO11), body temperature and blood oxygen saturation, quality of life (reported in the SF-36 generic quality of life questionnaires) and safety (adverse events, including worsening of patient status/symptoms) over time.
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