PM, MF, DG, CS and BS are employed at URSAPHARM Arzneimittel GmbH. Boots cold and flu nasal spray that costs just 6 could stop - The Sun 48.9% (n=44) of the safety analysis set was male, and the average age was 35.6712.94years. URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany is the sponsor of the clinical trial. An essential round-up of science news, opinion and analysis, delivered to your inbox every weekday. Comirnaty is the FDA-approved monovalent COVID-19 (coronavirus 2019) vaccine made by Pfizer for BioNTech. Mice treated with just a single dose of N-0385 on the day they were infected had a high survival rate as well. https://doi.org/10.2147/idr.S391630 (2022). ISSN 2045-2322 (online). The active substance (azelastine hydrochloride) is a histamine-1 receptor antagonist, which shows anti-inflammatory effects via mast cell stabilization and inhibition of leukotriene and pro-inflammatory cytokine production2,3,4. Carrouel, F. et al. PubMed Within this context it is important to point out that in vitro data indicate efficacy of azelastine against various SARS-CoV-2 variants tested10. 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. Rep. 117 https://doi.org/10.1007/s43440-023-00463-7. 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. In addition, presence or absence of fever (38.0C) was documented daily (0=no fever, 3=fever). the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Intranasal proteins could protect against COVID-19 variants We are aware that this limited the capture of COVID-19 specific issues as questions were not specifically aimed for COVID-19 patients. 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. Pharmacol. was the principal investigator responsible for the conduct of the study, M.G. Virological assessment of hospitalized patients with COVID-2019. Ralph Msges. This is similar to the natural SARS-CoV-2 clearance time of approximately 2weeks. Various studies have looked at the role of different foods in preventing coronavirus infection severe Covid-19 These include seaweed and grapefruit-based nasal sprays, dark chocolate, tuna. Google Scholar. Google Scholar. A nasal and mouth spray called "IGM-6268" is in the early stages of clinical trials. The trial protocol and the data are however available from the authors upon reasonable request and with permission of URSAPHARM Arzneimittel GmbH. J. Early intervention with azelastine nasal spray may reduce viral load in Intern. Nature (Nature) and F.H. 8, e70. We acknowledge support for the Article Processing Charge from the DFG (German Research Foundation, 491454339). Xlear have developed and patented a xylitol containing nasal spray for the treatment of upper-respiratory tract infections. Med. 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). 62, 50937, Cologne, Germany, You can also search for this author in Data was analysed primarily exploratively; there was no formal testing of a given hypothesis. The most common COVID-19 symptoms (loss of sense of smell, loss of taste, fever, cough, and coryza) improved over time in all 3 treatment groups; and no statistical differences were observed between groups. Within the subgroup of patients with baseline Ct values below 25, a similar progression of viral load data was observed (Fig. Viruses 13, 895. https://doi.org/10.3390/v13050895 (2021). TriSb92 could effectively tip the balance in favor of the [the person] and thereby help to reducethe risk of severe COVID-19 disease, she said.. To obtain Objective of the study is to assess the efficacy of Carragelose nasal and throat spray in reducing the rate, severity, and duration of COVID-19 infections. https://doi.org/10.1007/s10787-021-00847-2 (2021). Levine-Tiefenbrun, M. et al. Pharmacol. When the treatment course was shortened to four days, starting one day before infection, all 10 of the mice treated with N-0385. Article However, examples of prolonged nasal positivity have also been reported, and many factors are known to have an influence on the individual viral load and clearance27. 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. Wiesmller (health authorities Cologne, Germany) for his support regarding regulatory issues, PD Dr. E. Raskopf for editorial assistance, and H. Papp for her assistance in PCR control experiments. Striking antibody evasion manifested by the Omicron variant of SARS-CoV-2. https://doi.org/10.1001/jamaoto.2020.5490 (2021). Sci Rep 13, 6839 (2023). It can be used to help return your sense of smell if it was lost during a viral infection or minor head trauma. Google Scholar. This same site is shared among many variants of the COVID virus, so it could be effective against future variants as well, researchers note. 62, 50937, Cologne, Germany, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne, Kerpener Str. 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, One of these smaller antibodies is being developed, to develop synthetic nanobodies; and in a third case, researchers isolated nanobodies. Can Nasal Sprays Treat or Prevent COVID-19? - GoodRx 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). 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. Comirnaty may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19. Bullinger, M., Kirchberger, I. Thank you for visiting nature.com. In a study funded by NIAID, researchers are using mice to look for genes that account for different COVID-19 symptoms. In this context, it is interesting to note that publications indicate that individuals vaccinated against SARS-CoV-2 have lower viral loads and are less contagious24,25. was responsible for the patient disposition. Slider with three articles shown per slide. A summary of study activities is displayed in Table 2. Pharmacother. https://doi.org/10.1038/s41591-021-01316-7 (2021). These nanobodies and TriSb92 target a specific part of the coronavirus spike protein called the receptor-binding domain (RBD). Jain, R. & Mujwar, S. Repurposing metocurine as main protease inhibitor to develop novel antiviral therapy for COVID-19. To obtain Nature 602, 676681. https://doi.org/10.1080/14787210.2021.1908127 (2021). 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. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. 2 and supplementary Table S2). 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. Applied treatment regimens aimed to explore differences regarding viral carriage upon treatment with azelastine compared to placebo. PubMed Now, researchers at Swansea University will test Boots' Dual Defence Nasal Spray, which costs 5.99 for 20ml, against Covid-19. Get the most important science stories of the day, free in your inbox. COVID-19 nasal sprays may one day prevent and treat infection - ABC The aim of our study was to support the preclinical evidence for azelastines antiviral activity in patients tested positive for SARS-CoV-2. Cite this article. Thus, a nitric oxide nasal spray was shown to reduce the viral load in adult patients with mild COVID-19 infection, and an accelerated SARS-CoV-2 clearance compared to placebo was demonstrated18. 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 . and B.S. ADS Acta Pharmacol. 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). Antiviral activity was subsequently verified in cell culture. 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. Three-group comparisons were analysed with KruskalWallis test. 1). Identification of 14 known drugs as inhibitors of the main protease of SARS-CoV-2. It's a type of antibody that targets the coronavirus' spike protein. For calibration purposes of quantitative assessments, reference samples were included with each PCR run. Decreases of viral load were also reflected in increases of negative PCR results over time. Vitiello, A., Ferrara, F., Troiano, V. & La Porta, R. COVID-19 vaccines and decreased transmission of SARS-CoV-2. MG, PA, HM and HAS declare no conflict of interest. All authors contributed to the preparation of the manuscript, read and approved the manuscript. In a subset of patients (initial Ct<25) viral load was strongly reduced on day 4 in the 0.1% group compared to placebo (p=0.005). 24 COVID-19 status classified as negative, asymptomatic, mild, or severe. 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. Boots nasal spray containing seaweed could fight Covid-19 The independent 25 variable was the nasal carriage of Bacillus species. The current study demonstrated a gradual decrease of patients symptoms and improvements of quality of life. Will there be a COVID winter wave? Med. 8, 701709. Jean, F. (2022). P.A.de.A., H.M. and H.A.S. Postdoctoral Fellow Scholarship at Dept of Biochemistry of Vanderbilt University. This trial was conducted at the Department of Otorhinolaryngology, Head and Neck Surgery of the Faculty of Medicine of the University of Cologne, Germany. Reznikov et al. The analysis of sum symptom scores showed that the study population (ITT analysis set) suffered from moderate symptoms (mean valuesSD: 38.5810.04) on day 1 of the study (supplementary Table S5). 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. Anna R. Mkel, PhD, senior scientist, Department of Virology, University of Helsinki, Finland. The liquid contains NO at 0.11 ppm*hour, which acts as a viricidal agent. Article IGM-6268. Lee, C. & Corren, J. 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. 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. Infect. Duration of culturable SARS-CoV-2 in hospitalized patients with covid-19. 03:08. . Jean, F. (2022). C.L. Nature 581, 465469. TMPRSS2 is a protein in mouse and human cells that SARS-CoV-2 uses as a gateway to infect humans. De Vries, R. D. 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. 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. 18, 110. https://doi.org/10.1186/s12985-021-01559-3 (2021). Simon, M. W. The efficacy of azelastine in the prophylaxis of acute upper respiratory tract infections. KaplanMeier analysis results regarding the ORF 1a/b gene from baseline (day 1) until day 11 of treatment (ITT analysis set). 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., . Researchers have looked for ways to prevent SARS-CoV-2 infection that the virus cant learn to dodge or evade by mutating. AB is employed at Ursatec GmbH, supplier of primary packing materials to Ursapharm. 4). 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 It was more effective against the virus, though, when given before infection rather than after, perhaps due to the initial establishment of the infection," the researchers note. All rights reserved. Patients of the current trial were eligible upon positive PCR test results, and if enrolled no later than 48h after swab sampling. Since the start of the COVID-19 pandemic, its treatment via the nasal route has been studied for a range of drugs17. Smell Retraining Therapy - ENT Health Clinical efficacy of nitric oxide nasal spray (NONS) for the treatment of mild COVID-19 infection. Study finds nasal spray could aid battle against COVID 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: Guenezan, J. et al. . 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. ACS Med. This observational study (HUN-VE: Hungarian Vaccine Effectiveness) estimated vaccine effectiveness against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and COVID-19-related mortality in 3.7 million . All tests were performed two-sided and the type 1 error () was set to 5%. Pharmaceutics 14, 2502. https://doi.org/10.3390/pharmaceutics14112502 (2022). ICE-COVID, will investigate whether Dual Defence can either prevent Covid-19 infection or reduce . Whether the current data can be extrapolated to other SARS-CoV-2 variants needs to be investigated. 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. ISSN 1476-4687 (online) The current proof-of-concept study served to investigate if nasally applied azelastine may have the potential to reduce the viral load (via blocking viral entry and viral replication) in patients tested positively for SARS-CoV-2. https://doi.org/10.1517/14656566.8.5.701 (2007). Biochem. Ann. 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. Data on virus variants was available for 59 patients and 54 (92%) of those carried the alpha (B.1.1.7) variant. Google Scholar. Patients had to daily document their COVID-19 specific symptoms in an electronic patient diary. 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 . Patient Rep. Outcomes 6, 26. https://doi.org/10.1186/s41687-022-00434-1 (2022). Thus, eligibility criteria were designed carefully to investigate a clearly defined, homogeneous study population of low-risk patients with a narrow age range. June 10, 2022 at 2:00 pm. But the spike protein may mutate to evade immune response. Early intervention with azelastine nasal sprays reduces viral load in SARS-CoV-2 infected patients. . This is exemplified by the emergence of the highly immune evasive omicron variant that is resistant to many monoclonal antibodies authorized for clinical use34. JAMA Otolaryngol. 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. PubMed Central Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults. Sin. 11, 25262533. 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. For hygiene reasons, it is preferable not to share the same nasal spray with other people. PDF Effect of nasal carriage of Bacillus species on COVID-19 severity: A Molecular docking and dynamics simulation of FDA approved drugs with the main protease from 2019 novel coronavirus. Absolute changes in viral copy numbers (log10 cp/ml) from baseline (day 1) over time based on the ORF 1a/b gene (Ct<25 analysis set). Anticipating a drop-out rate of 20%, the aim was to randomize 90 patients in total (30 patients per treatment group) to result in 23 patients per treatment group completing the study and being eligible for analysis. 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. One misinformed. FH is the CEO of URSAPHARM Arzneimittel GmbH. Resource-efficient internally controlled in-house real-time PCR detection of SARS-CoV-2. Investigators and trial participants were masked to the treatment as investigational medicinal products were identical in appearance. Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients, https://doi.org/10.1038/s41598-023-32546-z. https://doi.org/10.1007/s11739-021-02786-w (2021). In the meantime, to ensure continued support, we are displaying the site without styles Outpatients visiting Corona test centres were informed about the possibility of participating in the trial. All nasal sprays were composed of hypromellose, disodium edetate, citric acid, disodium phosphate dodecahydrate, sodium chloride and purified water. Ethics approval was granted by the Ethics Committee of the Faculty of Medicine of Cologne University on the 10th of February 2021. 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). Ctcycle threshold. How nasal-spray vaccines could change the pandemic, How much virus does a person with COVID exhale? 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. Following translocation from nucleus to the endoplasmic reticulum (ER), the sigma-1 receptor (among other factors) plays a role in viral replication. 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. 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. Boots Dual Defence Nasal Spray 20ml - Boots 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. The researchers picked four compounds that worked at very low concentrations and did not negatively affect the host cells. A complete list of inclusion and exclusion criteria is presented in Table 1. 27, 790792. The team will enrol 480 healthworkers, including nurses and doctors . https://doi.org/10.1038/s41598-023-32546-z, DOI: https://doi.org/10.1038/s41598-023-32546-z. 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. 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. Identification of antiviral antihistamines for COVID-19 repurposing. Now, researchers at Swansea University will test it against Covid-19. Marinomed plans a clinical trial with Carragelose nasal spray as COVID 16, 275282. Components are mixed from two chambers to create the final NO-producing formulation. Could a Nasal Spray of Designer Antibodies Help to Beat COVID-19? Lancet Respir. https://doi.org/10.1016/s1473-3099(20)30483-7 (2020). PubMedGoogle Scholar. Symptoms were documented in patient diaries. 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). Boots Dual Defence Nasal Spray Bundle 4X 20ml - Boots Thus, it should be kept in mind that treatment started at a time point where the peak of viral load had probably passed. Provided by the Springer Nature SharedIt content-sharing initiative. SRT was originally developed in 2009 by Dr. Thomas Hummel at the University of Dresden. 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. Yang, L. et al. Nat. 19(10), 16. Comirnaty COVID-19 mRNA Vaccine Information - Drugs.com Patients were visited and tested at home on regular basis by the investigators, physicians specialised in otorhinolaryngology, medical hygiene, or general medicine. Marshall, J. C. A minimal common outcome measure set for COVID-19 clinical research. Both descriptive and exploratory statistics were performed. 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. The researchers first tried one dose a day for seven days, starting a day before SARS-CoV-2 infection. Wlfel, R. et al. Boots UK - Swansea University Research Study of NHS Frontline Workers Povidone iodine mouthwash, gargle, and nasal spray to reduce nasopharyngeal viral load in patients with COVID-19: A randomized clinical trial. 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.