CAS The Sponsor designed a dual chamber nasal spray bottle for NORS administration. These nanobodies and TriSb92 target a specific part of the coronavirus spike protein called the receptor-binding domain (RBD). C.A. Cornell research team to develop COVID-19 nose spray treatment. Liu, L. et al. Prevention is the best medicine, and COVID-19 vaccines block most SARS-CoV-2 infections. Sirijatuphat, R., Leelarasamee, A., Puangpet, T. & Thitithanyanont, A. Investigators assessed patients status throughout the trial including safety follow-ups (days 16 and 60). N.W. Get the most important science stories of the day, free in your inbox. Virol. Allergy Asthma Immunol. "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. De Vries, R. D. et al. Vitiello, A., Ferrara, F., Troiano, V. & La Porta, R. COVID-19 vaccines and decreased transmission of SARS-CoV-2. Treatment kits were manufactured by URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany, according to the randomization list (as sequentially numbered containers). 31(6), 113. 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). 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. Elife 10, e69302. Data on virus variants was available for 59 patients and 54 (92%) of those carried the alpha (B.1.1.7) variant. Recent publications indicating that in vitro infectivity correlates with high virus concentrations (Ct25) in nasal swabs28,29,30 underline the importance of analysis of this subset population. Correspondence to 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. Struct. Lancet Respir. It would be desirable to extend the investigation of azelastine nasal spray as potential antiviral treatment with in vitro culture experiments. 24 COVID-19 status classified as negative, asymptomatic, mild, or severe. Area under the curve (AUC) reflecting changes in viral copy numbers (log10 cp/mL) from baseline (day 1) over time (until day 11) based on the ORF 1a/b gene (ITT analysis set). Of note, 30 (non-related) adverse events in 13 patients (7 patients with 16 events in the 0.1% azelastine, 2 patients with 4 events in the 0.02% azelastine, and 4 patients with 10 events in the placebo group) were still ongoing at the final safety follow up on day 60. For hygiene reasons, it is preferable not to share the same nasal spray with other people. Der deutsche SF-36 health survey bersetzung und psychometrische testung eines krankheitsbergreifenden instruments zur erfassung der gesundheitsbezogenen lebensqualitt. Marc, A. et al. and B.S. 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. Our study showed both strengths and limitations. Investigators and trial participants were masked to the treatment as investigational medicinal products were identical in appearance. Commun. 10, 294. https://doi.org/10.3389/fphar.2019.00294 (2019). Amdal, C. D. et al. Konrat, R. et al. Emerg. Samples were processed on the day of receipt at the central processing laboratory (Institute of Virology, University Hospital Cologne, Cologne, Germany) by vortexing and aliquoting the viral transport medium and stored at80C until analysis. Components are mixed from two chambers to create the final NO-producing formulation. Article Google Scholar. Symptoms were documented in patient diaries. 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). By application of a novel computational approach based on Shannon entropy homology, Konrat et al. 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. 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 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. drafted the manuscript. Of note, pharmacometric analyses of our data indicate that more frequent applications of the nasal spray may be more appropriate for efficient treatment35. Boots Dual Defence Nasal Spray is used to dampen the symptoms of cold and flu. Overall, data of the primary outcome did not show a normal distribution (ShapiroWilk test, p<0.05). A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic. 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. All tests were performed two-sided and the type 1 error () was set to 5%. Dis. 20, e192e197. ADS PubMed H.S. On days 1, 5, 8 and 11, patients completed the standardized SF-36 questionnaire of quality of life. Levine-Tiefenbrun, M. et al. Instructions for storing, preparing, and administering the study treatment will be provided to participants. 147, 400401. ACS Med. 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. https://doi.org/10.1038/s41598-023-32546-z, DOI: https://doi.org/10.1038/s41598-023-32546-z. Inhibition of SARS-CoV-2 by bentonite-based nasal spray. Clinical efficacy of nitric oxide nasal spray (NONS) for the treatment of mild COVID-19 infection. The primary endpoint of the CARVIN study was the assessment of virus load kinetics of SARS-CoV-2 by determining the presence and amount of viral carriage via PCR. The RBD is where the coronavirus attaches to cells in the body. Pujadas, E. et al. Applied treatment regimens aimed to explore differences regarding viral carriage upon treatment with azelastine compared to placebo. Michel, J. et al. A study led by an expert from The University of Western Australia has found a virus-killing nasal spray could be effective in reducing the spread of COVID-19. New research has answers, COVID's future: mini-waves rather than seasonal surges, Are repeat COVID infections dangerous? The sprays generally require multiple doses per day, whereas a single dose of a nasal vaccine may protect for months, he said. 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. 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. 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. 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. This way, the virus moves on.. Pharmaceutics 14, 2059. https://doi.org/10.3390/pharmaceutics14102059 (2022). Z. Gesundheitswissenschaften J. About 388 participants were included in the study Internet Explorer). 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. 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. https://doi.org/10.2147/idr.S391630 (2022). PubMed Lancet Infect. Infect. Inhibition of leukotriene synthesis by azelastine. 538, 173179. Nasal sprays may be a promising first line of defense against SARS-CoV-2 infection. Striking antibody evasion manifested by the Omicron variant of SARS-CoV-2. In an in vitro screening of 1,800 approved drugs by use of a SARS-CoV-2-S pseudovirus entry inhibitor model, 15 drugs were identified as active inhibitors, but only seven of these drugs were identified as active against SARS-CoV-2, three of which were anti-histamines: clemastine, trimeprazine and azelastine hydrochloride5. https://doi.org/10.1007/s11224-020-01605-w (2020). JAMA 325, 632644. EudraCT number: 2020-005544-34. Recently, Shmuel et al. 62, 50937, Cologne, Germany, You can also search for this author in 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. https://doi.org/10.7554/eLife.69302 (2021). Symptoms were analyzed as single symptom scores, and as the total symptom score (TSS) reflecting the sum of all 20 single symptoms and presence/absence of fever (reaching a minimum value of 20 and maximum value of 103). A summary of study activities is displayed in Table 2. Bullinger, M., Kirchberger, I. 384, 671673. 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. analyzed 219,000 medical records in a retrospective data base survey study and demonstrated that azelastine showed the highest association between prior usage among these antihistamines and SARS-CoV-2 negative test results in patients above the age of 60 (OR: 2.43; 95% CI: 1.474.02). Pharmacother. Ther. The liquid contains NO at 0.11 ppm*hour, which acts as a viricidal agent. . The trial protocol and the data are however available from the authors upon reasonable request and with permission of URSAPHARM Arzneimittel GmbH. JPK and CL have received grants from the sponsor URSAPHARM Arzneimittel GmbH for performing this trial. The sample size calculation was based on the expected reduction of virus load during the treatment considering 3 treatment arms. Intern. 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. All rights reserved. Nature (Nature) 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.. Of note, in vitro tests carried out prior to the current study did not indicate any interaction between the study products and the PCR reaction (see supplementary PCR data). WebMD does not provide medical advice, diagnosis or treatment. June 10, 2022 at 2:00 pm. Patient Rep. Outcomes 6, 26. https://doi.org/10.1186/s41687-022-00434-1 (2022). 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. The shown effects of azelastine nasal spray may thus be suggestive of azelastines potential as an antiviral treatment. For clarity reason, only cp/mL values of the ORF 1a/b gene are shown in the main text of the manuscript. 48.9% (n=44) of the safety analysis set was male, and the average age was 35.6712.94years. Study endpoints were presented by descriptive statistics, aiming to compare the course of viral load between the three treatment groups. Google Scholar. Smell Retraining Therapy. https://doi.org/10.1016/s1081-1206(10)63465-5 (1996). During the throes of the COVID-19 pandemic, Anne Moscona didnt feel safe going to a restaurant or catching a flight. Initial report of decreased SARS-CoV-2 viral load after inoculation with the BNT162b2 vaccine. Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients. Indeed, the majority of the study subjects carried this variant. Kim, M.-C. et al. Now, researchers at Swansea University will test it against Covid-19 Now, researchers at Swansea University. Pediatr. 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. Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail is a medical device innovated to provide the dual-action physical barrier on nasal mucosa that aids the natural defence in which the mucus layer is fortified by a steric barrier-forming agent HPMC and invading viral particles of all major SARS-CoV-2 Infect. Informed consent was obtained from all participants prior to involvement in the study. Suitable for Researchers have looked for ways to prevent SARS-CoV-2 infection that the virus cant learn to dodge or evade by mutating. Shapira, T. et al. 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. CAS 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. 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.. Comparable numbers of adverse events occurred in all treatment groups with no safety concerns. Wlfel, R. et al. The most promising compound, N-0385, virtually stopped infection in its tracks. 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. 42, 17. https://doi.org/10.1007/s11739-021-02786-w (2021). Overall, no statistical differences between groups were determined. AB is employed at Ursatec GmbH, supplier of primary packing materials to Ursapharm. For male patients, the assessment was done via phone call. 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). D.G., C.S. https://cornellsun.com/2022/04/27/cornell-research-team-to-develop-covid-19-nose-spray-treatment/, Shapira, T., Monreal, I. All authors contributed to the preparation of the manuscript, read and approved the manuscript. We would like to thank Prof. G.A. The aim of our study was to support the preclinical evidence for azelastines antiviral activity in patients tested positive for SARS-CoV-2. The surface of SARS-CoV-2, the virus that causes COVID-19, is covered with spike proteins. [1] Nasal delivery of an IgM offers broad protection from SARS-CoV-2 variants. 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. The current study was a randomized, parallel, double-blind, placebo-controlled trial. Jean, F. (2022). was responsible for the patient disposition. Med. For data analysis, negative PCR results were replaced with the Ct value 45 and the cp/mL value 1, respectively. SARS-CoV-2 infection progression starts with viral entrance mediated by the spike glycoproteins interaction with the host ACE2 receptor molecule. https://doi.org/10.1089/088318703322751327 (2004). PubMed Med. From hydroxychloroquine and veterinarian doses of the antiparasitic drug ivermectin, questionableand potentially harmfultreatments for COVID-19 have circulated the internet. COVID-19 vaccines teach the immune system to recognize a particular protein on SARS-CoV-2 that is known as the spike protein. 2005 - 2023 WebMD LLC, an Internet Brands company. 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. URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany is the sponsor of the clinical trial. ITTintention to treat. 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. 62, 50937, Cologne, Germany, Henning Gruell,Maike Schlotz&Florian Klein, Ursatec GmbH, Marpinger Weg 4, 66636, Tholey, Germany, ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668, Cologne, Germany, Belisa Russo,Susanne Mller-Scholtz,Cengizhan Acikel,Hacer Sahin,Nina Werkhuser,Silke Allekotte&Ralph Msges, Institute of Medical Statistics and Computational Biology (IMSB), Faculty of Medicine, University of Cologne, Kerpener Str. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. https://doi.org/10.1016/j.jinf.2021.05.009 (2021). A complete list of inclusion and exclusion criteria is presented in Table 1. Nasopharyngeal swabs were obtained by investigators using nylon-flocked swabs (Biocomma; SW01E, flexible minitip, Biocomma, Shenzen, China). Xlear have developed and patented a xylitol containing nasal spray for the treatment of upper-respiratory tract infections. https://doi.org/10.1021/acsmedchemlett.0c00521 (2020). Med. Sign up for the Nature Briefing newsletter what matters in science, free to your inbox daily. Center for Molecular Medicine Cologne (CMMC), Faculty of Medicine and University Hospital, University of Cologne, Kerpener Str. Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: A randomized clinical trial. Samples of day 1 represent pre-treatment baseline samples. 83, 237279. It can be used to help return your sense of smell if it was lost during a viral infection or minor head trauma. 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. 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. One study of about 400 health-care workers suggests a nasal spray may reduce the incidence of COVID-19 by up to 80 per cent. The current study demonstrated a gradual decrease of patients symptoms and improvements of quality of life. 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. It would be desirable to use a validated, COVID-19 specific questionnaire in future studies, and first attempts for its development are promising32. Article performed and supervised sample processing and viral load measurements. Treatment of COVID-19 with a hypertonic solution containing seawater, xylitol, panthenol and lactic acid was shown to reduce the viral shedding time in patients with asymptomatic or mild COVID-1920, whereas application of povidone iodine nasal spray showed only poor influence on SARS-CoV-2 viral titres21,22.
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