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. CAS For hygiene reasons, it is preferable not to share the same nasal spray with other people. Center for Molecular Medicine Cologne (CMMC), Faculty of Medicine and University Hospital, University of Cologne, Kerpener Str. Article Slider with three articles shown per slide. This is exemplified by the emergence of the highly immune evasive omicron variant that is resistant to many monoclonal antibodies authorized for clinical use34. Internet Explorer). Overall, no significant differences were observed between treatment groups regarding gender, age and body mass index (bmi, supplementary Table S1). The sprays generally require multiple doses per day, whereas a single dose of a nasal vaccine may protect for months, he said. Whether the current data can be extrapolated to other SARS-CoV-2 variants needs to be investigated. Bioinformation 16, 236244. 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., . N. Engl. 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. The current study was a randomized, parallel, double-blind, placebo-controlled trial. 5) Of note, these differences were not statistically significant (p=0.112). Nasal sprays may be a promising first line of defense against SARS-CoV-2 infection. https://doi.org/10.1038/s41586-021-04388-0 (2022). All nasal sprays were composed of hypromellose, disodium edetate, citric acid, disodium phosphate dodecahydrate, sodium chloride and purified water. Postdoctoral fellowship in vascular biology at UT Southwestern, studying the endothelial basis of cardiometabolic disease. Indeed, the majority of the study subjects carried this variant. Although it may be expected that the azelastine might be most efficacious during very early time points after infection, its application in the current study setting could only be started during the symptomatic phase of the disease. Smell Retraining Therapy. How nasal-spray vaccines could change the pandemic, How much virus does a person with COVID exhale? EudraCT number: 2020-005544-34. 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. Researchers plan to continue testing the timing of when N-0385 should be administered and to expand testing into human clinical trials. Anti. The physical and mental health summary scores of the SF-36 questionnaire improved during the course of the treatment without statistical differences between groups (data not shown). . Those compounds were tested in human lung and colon cells that were then exposed to SARS-CoV-2. The dual-target RT-PCR independently targets the ORF1a/b and the sarbecovirus E genes, and assays were considered positive if at least one target returned a positive result (Ct values reflecting an inverse relationship with viral load). N.W. 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. Get the most important science stories of the day, free in your inbox. 83, 237279. Initial report of decreased SARS-CoV-2 viral load after inoculation with the BNT162b2 vaccine. Acta Pharmacol. TMPRSS2 is a protein in mouse and human cells that SARS-CoV-2 uses as a gateway to infect humans. Reznikov, L. R. et al. 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 . The researchers first tried one dose a day for seven days, starting a day before SARS-CoV-2 infection. You are using a browser version with limited support for CSS. The sprays would be fast-acting and would be applied frequently, perhaps once or. The product targets a stable site on the spike protein of the virus that is not known to mutate. The aim of our study was to support the preclinical evidence for azelastines antiviral activity in patients tested positive for SARS-CoV-2. The patient status was assessed at V1V7 and at V9 by the investigators with a 11-category ordinal score proposed by the WHO11. PubMed PubMed Central Cornell research team to develop COVID-19 nose spray treatment. This same site is shared among many variants of the COVID virus, so it could be effective against future variants as well, researchers note. Pharmacother. Nature, 10.1038/s41586-022-04661-w. Advance online publication. 13, 861295. https://doi.org/10.3389/fphar.2022.861295 (2022). Front. If delivery took place within 24h after sampling, samples were to be stored at<25C, if storage period was greater than 24h (e.g., on Sundays), samples had to be stored and shipped at 28C. It would be desirable to extend the investigation of azelastine nasal spray as potential antiviral treatment with in vitro culture experiments. was responsible for the patient disposition. Both descriptive and exploratory statistics were performed. Sign up for the Nature Briefing newsletter what matters in science, free to your inbox daily. 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. 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. 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. The experimental drug works in mice, and researchers believe it may be effective in humans. 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. Gottlieb, R. L. et al. 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 . 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. . Dis. Pujadas, E. et al. Topol is also editor-in-chief of Medscape, WebMD's sister site for medical professionals. 10, 294. https://doi.org/10.3389/fphar.2019.00294 (2019). The Ct<25 group consisted of 19 patients in the 0.1% azelastine group, 21 patients in the 0.02% azelastine group and of 17 patients in the placebo group (Fig. Google Scholar. The azelastine 0.1% azelastine group displayed the greatest improvement of symptoms with 12.7410.74 mean score reduction. 62, 50937, Cologne, Germany, Jens Peter Klussmann,Maria Grosheva,Paula Aguiar de Arago,Henning Morr&Helal Al Saleh, URSAPHARM Arzneimittel GmbH, Industriestrae 35, 66129, Saarbruecken, Germany, Peter Meiser,Michael Flegel,Frank Holzer,Dorothea Gro,Charlotte Steinmetz&Barbara Scherer, Department I of Internal Medicine, Division of Infectious Diseases, University of Cologne, Kerpener Str. But the spike protein may mutate to evade immune response. CAS 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. Initial viral loads were log10 6.851.31 (meanSD) copies/mL (ORF 1a/b gene). 147, 400401. We acknowledge support for the Article Processing Charge from the DFG (German Research Foundation, 491454339). It's a type of antibody that targets the coronavirus' spike protein. was the principal investigator responsible for the conduct of the study, M.G. the epithelium, to recreate the first line of defense against respiratory viruses. Early intervention with azelastine nasal sprays reduces viral load in SARS-CoV-2 infected patients. By Dr. Ramya Dwivedi, Ph.D. Jul 19 2021. Ghahremanpour, M. M. et al. The Sponsor designed a dual chamber nasal spray bottle for NORS administration. Cornell Daily Sun. Chem. 62, 50937, Cologne, Germany, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne, Kerpener Str. Because we get infected with SARS-CoV-2 primarily by breathing it in, a nasal spray might be an easy and efficient way to offer protection against the virus, especially in crowded places. In the meantime, to ensure continued support, we are displaying the site without styles 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 Patient reported outcomes were documented by patient diaries and questionnaires. Yang, L. et al. Article drafted the manuscript. 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). At the end of the study (day 60), all except one single patient (placebo group) showed a score of 0. Future studies will help understanding the impact of azelastine hydrochloride in treating SARS-CoV-2 infected patients. Now, researchers at Swansea University will test it against Covid-19 Now, researchers at Swansea University. 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. 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. This trial was conducted at the Department of Otorhinolaryngology, Head and Neck Surgery of the Faculty of Medicine of the University of Cologne, Germany. Nature 605, 340348 (2022). "CofixRX is an antiviral nasal spray that offers up to 8 hours of protection from many cold and flu viruses." [from your CofixRx Nasal Spray product label] "Lasts for up to 8 hours per. 1). A study of frontline workers is looking into how a Boots nasal spray could prevent Covid-19. During visits, nasopharyngeal swabs were taken for quantitative PCR measurements, and investigators assessed the patient status in accordance with the WHO clinical progression scale11. Now, researchers at Swansea University will test it against Covid-19. Components are mixed from two chambers to create the final NO-producing formulation. Vincenzo Messina, Riccardo Nevola, Luigi Elio Adinolfi, Kara W. Chew, Carlee Moser, Davey M. Smith, Manaf AlQahtani, Nitya Kumar, Stephen L. Atkin, V. Spagnuolo, M. Guffanti, COVID-BioB study group, Manish C. Choudhary, Kara W. Chew, for the ACTIV-2/A5401 Study Team, Emma Pritchard, Philippa C. Matthews, Koen B. Pouwels, Vineet Agarwal, A. J. Venkatakrishnan, Venky Soundararajan, Pauline Maisonnasse, Jrmie Guedj, Roger Le Grand, Scientific Reports https://doi.org/10.1016/j.jinf.2021.05.009 (2021). 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. Of note, the mean viral load value showed small variability, thereby supporting the power of the current study. 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). A summary of study activities is displayed in Table 2. Our study showed both strengths and limitations. Approval of the study by the German Federal Institute for Drugs and Medical Devices (BfArM) was given on 3rd February 2021. Cegolon, L. et al. Continuous data were described by statistical estimates (mean, standard deviation, median, minimum, and maximum values). ITTintention to treat. PubMedGoogle Scholar. Chavda, V. P., Baviskar, K. P., Vaghela, D. A., Raut, S. S. & Bedse, A. P. (2023) Nasal sprays for treating COVID-19: A scientific note. Symptoms were documented in patient diaries. Article Michel, J. et al. Only one of the 20 mice given saline survived. https://doi.org/10.1016/s1473-3099(20)30483-7 (2020). 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. Amdal, C. D. et al. Google Scholar. 42, 17. Inflammopharmacology 29(5), 14. These nanobodies and TriSb92 target a specific part of the coronavirus spike protein called the receptor-binding domain (RBD). 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. De Vries, R. D. et al. Simon, M. W. The efficacy of azelastine in the prophylaxis of acute upper respiratory tract infections. 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. 6). 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. Researchers are developing coronavirus vaccines that will be sprayed up the nose. 24 COVID-19 status classified as negative, asymptomatic, mild, or severe. https://doi.org/10.1038/s41586-020-2196-x (2020). and showed they could neutralize the SARS-CoV-2 virus. 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). Viruses 12, 1384. https://doi.org/10.3390/v12121384 (2020). Therefore, the primary analysis for the viral loads was conducted non-parametrically. By application of a novel computational approach based on Shannon entropy homology, Konrat et al. At the end of the treatment, 48.2% of the patients of the 0.1% azelastine group showed no detection of the ORF 1a/b gene, whereas only 23.1% of patients of the placebo group showed negative PCR results (supplementary Table S4). The WHO clinical progression scale progressively decreased in all treatment groups during the study. 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. About 388 participants were included in the study Even in cases where the antiviral does not prevent coronavirus infection, the treatment could slow infection. 3). 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. 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. 62, 50937, Cologne, Germany, German Center for Infection Research (DZIF) Location Bonn-Cologne, Kerpener Str. During the throes of the COVID-19 pandemic, Anne Moscona didnt feel safe going to a restaurant or catching a flight. 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. https://doi.org/10.1001/jamaoto.2020.5490 (2021). The hope is the vaccines will build immunity in one spot the coronavirus often invades . Google Scholar. Of those, 81 patients belonged to the Intention-To-Treat (ITT) population, comprising randomised patients meeting the key eligibility criteria and having evaluable viral load data on day 1 (baseline) and on day 11 (end of treatment). https://doi.org/10.1038/s41401-020-00556-6 (2020). Nasal spray that protects against COVID-19 is also effective against the common cold . and JavaScript. 31(6), 113. 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. One puff of the respective nasal spray was applied per nostril, 3 times a day (morning, midday, evening). 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. Bullinger, M., Kirchberger, I. ISSN 1476-4687 (online) 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. 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). 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). 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. https://doi.org/10.1007/s11739-021-02786-w (2021). 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. reported that a low pH hypromellose nasal powder spray containing common components of nasal sprays could reduce SARS-CoV-2 infection rates19. Guenezan, J. et al. By blocking that access, compounds that target TMPRSS2 have the potential to be effective against both current and future variants. Currently, the jury is out on their effectiveness and evidence is still limited, but it's possible they could act as a prophylactic for a short period of time. Lett. Article 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%. contracts here. 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.. https://doi.org/10.1038/s41591-021-01316-7 (2021). What scientists say. Article 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). Preliminary results of the current study have been published as preprint15. Categorical data were described by absolute frequencies and percentage of valid cases. PubMed Central Google Scholar. Ann. Of those, 27 patients belonged to the 0.1% azelastine group, 28 patients to the 0.02% azelastine group and 26 patients to the placebo group (Fig. And she wished she could feel confident that she could see her immunocompromised relatives without inadvertently spreading the novel coronavirus to them. Inhibition of SARS-CoV-2 by bentonite-based nasal spray. Patient disposition. Patient Rep. Outcomes 6, 26. https://doi.org/10.1186/s41687-022-00434-1 (2022). 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). 4). Expert Opin. CAS Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. were involved in data management. Sirijatuphat, R., Leelarasamee, A., Puangpet, T. & Thitithanyanont, A. https://doi.org/10.1016/j.bbrc.2020.11.095 (2021). A pilot study of 0.4% povidone-iodine nasal spray to eradicate SARS-CoV-2 in the nasopharynx. On days 1, 5, 8 and 11, patients completed the standardized SF-36 questionnaire of quality of life. The mean bmi of participants was 24.915.27. Investigators and trial participants were masked to the treatment as investigational medicinal products were identical in appearance. Pharmacol. PubMed The independent 25 variable was the nasal carriage of Bacillus species. Res. The Coronavirus Immunotherapy Consortium identified new candidate drugs based on monoclonal antibodies in work funded by NIAID. Thank you for visiting nature.com. Comparable numbers of adverse events occurred in all treatment groups with no safety concerns. 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. Three-group comparisons were analysed with KruskalWallis test. The sample size calculation was based on the expected reduction of virus load during the treatment considering 3 treatment arms. 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. Ku Z, Xie X, Hinton PR, Liu X, Ye X, Muruato AE, Ng DC, Biswas S, Zou J, Liu Y, Pandya D, Menachery VD, Rahman S, Cao . COVID-19 Get the latest information from the CDC about COVID-19. However, the overall small number of participants limits conclusions, and results should be interpreted with care. Identification of 14 known drugs as inhibitors of the main protease of SARS-CoV-2. 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. 90 patients were recruited between 09/03/2021 and 28/04/2021, constituting the safety analysis set. 20, e192e197. Overall, no statistical differences between groups were determined. Those parameters were based on the COVID-19 symptoms published by the Robert Koch Institute (https://www.rki.de) at the time of the study. Levine-Tiefenbrun, M. et al. Marc, A. et al. Zapor, M. Persistent detection and infectious potential of SARS-CoV-2 virus in clinical specimens from COVID-19 patients. Detection of the alpha (B.1.1.7) variant was based on single nucleotide polymorphism analysis for SARS-CoV-2 spike gene mutation N501Y and deletion H69/V70. Overall, data of the primary outcome did not show a normal distribution (ShapiroWilk test, p<0.05). The liquid contains NO at 0.11 ppm*hour, which acts as a viricidal agent. https://doi.org/10.1517/14656566.8.5.701 (2007). 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. All rights reserved. Scientific Reports (Sci Rep) Treatment kits were manufactured by URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany, according to the randomization list (as sequentially numbered containers). To obtain Instructions for storing, preparing, and administering the study treatment will be provided to participants. 03:08. It also appears to work as a treatment if used within 4 hours after infection inside the nose, new research reveals., Known as TriSb92(brand name Covidin, from drugmaker Pandemblock Oy in Finland), the viral inhibitoralso appears effective against all coronavirus variants of concern, neutralizing even the Omicron variants BA.5, XBB, and BQ.1.1 in laboratory and mice studies., 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 the biotechnology company set up to develop the treatment.. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. Front. In addition, patient's quality of life was evaluated by the SF-36 questionnaire, covering 36 items divided into the 8 quality of life domains physical functioning; role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health12. Shapira, T., Monreal, I. Trial registration: The study was registered in the German Clinical Trial Register (DRKS-ID: DRKS00024520; Date of Registration in DRKS: 12/02/2021). The company led byMkel is now working to secure funding for clinical trials of TriSb92 in humans.. 27, 790792. 8, e70. URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany is the sponsor of the clinical trial. https://doi.org/10.1016/s2213-2600(20)30354-4 (2020). https://doi.org/10.1007/s10787-021-00847-2 (2021). New research has answers, COVID's future: mini-waves rather than seasonal surges, Are repeat COVID infections dangerous? Pawar, R. D. et al. 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. 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. CAS Ethics approval was granted by the Ethics Committee of the Faculty of Medicine of Cologne University on the 10th of February 2021. Antiviral efficacy was observed at an EC50 of~6M, which is an approximately 400-fold lower concentration compared to commercially available azelastine nasal sprays. Wlfel, R. et al. . Google Scholar. & Ware, J.
Mickleover To Findern Walk,
Babylock Soprano Vs Brilliant,
Dillards Return Policy On Fragrance,
Articles D
