Treatment kits were manufactured by URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany, according to the randomization list (as sequentially numbered containers). Of note, we cannot rule out the possibility that the placebo (nasal spray buffer) contributed to viral clearance. Der deutsche SF-36 health survey bersetzung und psychometrische testung eines krankheitsbergreifenden instruments zur erfassung der gesundheitsbezogenen lebensqualitt. Ralph Msges. We acknowledge support for the Article Processing Charge from the DFG (German Research Foundation, 491454339). Nature 605, 340348 (2022). The WHO clinical progression scale progressively decreased in all treatment groups during the study. Internet Explorer). Resource-efficient internally controlled in-house real-time PCR detection of SARS-CoV-2. Similarly, no clinically relevant differences regarding blood oxygen saturation values were detected between groups (data not shown). https://doi.org/10.1038/s41591-022-01780-9 (2022). Categorical data were described by absolute frequencies and percentage of valid cases. 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. Study endpoints were presented by descriptive statistics, aiming to compare the course of viral load between the three treatment groups. 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: 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. 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. Ghahremanpour et al. Dis. 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. Vitiello, A., Ferrara, F., Troiano, V. & La Porta, R. COVID-19 vaccines and decreased transmission of SARS-CoV-2. 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. Google Scholar. The experimental drug works in mice, and researchers believe it may be effective in humans. Article 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. 18, 110. https://doi.org/10.1186/s12985-021-01559-3 (2021). Now, researchers at Swansea University will test Boots' Dual Defence Nasal Spray, which costs 5.99 for 20ml, against Covid-19. 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 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. 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. PubMed 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. Jean, F. (2022). Sign up for the Nature Briefing newsletter what matters in science, free to your inbox daily. 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 . As expected, a continuous decrease in the mean virus load was observed in all study groups during the 11 treatment days. Ghahremanpour, M. M. et al. Article Eric Topol, MD, director and founder, Scripps Research Translational Institute, La Jolla, CA; editor-in-chief, Medscape. This is exemplified by the emergence of the highly immune evasive omicron variant that is resistant to many monoclonal antibodies authorized for clinical use34. Allergy Asthma Immunol. Ctcycle threshold. [1] Nasal delivery of an IgM offers broad protection from SARS-CoV-2 variants. AB is employed at Ursatec GmbH, supplier of primary packing materials to Ursapharm. 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. 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). https://doi.org/10.1016/s1473-3099(20)30483-7 (2020). Researchers have looked for ways to prevent SARS-CoV-2 infection that the virus cant learn to dodge or evade by mutating. reported that a low pH hypromellose nasal powder spray containing common components of nasal sprays could reduce SARS-CoV-2 infection rates19. 1). Molecular docking and dynamics simulation of FDA approved drugs with the main protease from 2019 novel coronavirus. We would like to thank Prof. G.A. & Ware, J. Our study showed both strengths and limitations. Get the most important science stories of the day, free in your inbox. Following sampling, swabs were placed into 3mL Virus Transport Medium (VTM, Biocomma) and delivered to the laboratory as quickly as possible. 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.. Yang, L. et al. 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.. https://doi.org/10.7554/eLife.69302 (2021). CAS performed the statistical analysis. Asthma Allergy Immunol. 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. 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 . Med. To obtain 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). Pharmaceutics 14, 2502. https://doi.org/10.3390/pharmaceutics14112502 (2022). 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. Identification of 14 known drugs as inhibitors of the main protease of SARS-CoV-2. Pujadas, E. et al. In the meantime, to ensure continued support, we are displaying the site without styles 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. 11, 25262533. 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. 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. Applied treatment regimens aimed to explore differences regarding viral carriage upon treatment with azelastine compared to placebo. were investigators involved in the conduct of the study. 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. Article Article To infect a cell, the virus tricks several of that cells proteins, including one called TMPRSS2, to gain entry. Even in cases where the antiviral does not prevent coronavirus infection, the treatment could slow infection. When treated with N-0385, 70% of the mice survived and had little to no lung damage. 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. Front. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiological . Sci Rep 13, 6839 (2023). By Dr. Ramya Dwivedi, Ph.D. Jul 19 2021. Ethics approval was granted by the Ethics Committee of the Faculty of Medicine of Cologne University on the 10th of February 2021. Jean, F. (2022). 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. Nasal sprays may be a promising first line of defense against SARS-CoV-2 infection. Anti. Nature (Nature) MG, PA, HM and HAS declare no conflict of interest. Scientists are working on fast-acting nasal sprays to block coronavirus infections but formulating the sprays is a challenge. Striking antibody evasion manifested by the Omicron variant of SARS-CoV-2. Z. Gesundheitswissenschaften J. The researchers compared mice treated with TriSb92 before and after exposure to SARS-CoV-2. 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. Sirijatuphat, R., Leelarasamee, A., Puangpet, T. & Thitithanyanont, A. JPK and CL have received grants from the sponsor URSAPHARM Arzneimittel GmbH for performing this trial. 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. Slider with three articles shown per slide. 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. 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. 10, 294. https://doi.org/10.3389/fphar.2019.00294 (2019). Associate Professor Peter Friedland, from UWA's Medical School, was lead author of the study In vivo . 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. Inhibition of SARS-CoV-2 by bentonite-based nasal spray. 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. Ninety SARS-CoV-2 positive patients were randomized into 3 groups receiving placebo, 0.02% or 0.1% azelastine nasal spray for 11days, during which viral loads were assessed by quantitative PCR. https://doi.org/10.1038/s41401-020-00556-6 (2020). Pharmacol. was responsible for data management activities. 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. A summary of study activities is displayed in Table 2. the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in (2021) COVID-19: Azelastine nasal spray reduces virus-load in nasal swabs (CARVIN). Patient reported outcomes were documented by patient diaries and questionnaires. Prevention is the best medicine, and COVID-19 vaccines block most SARS-CoV-2 infections. Article The nasal spray, which contains carragelose, a patented version of iota-carrageenan (a form of seaweed), has already been proven to help shorten the duration and severity of cold and flu-like. Winchester, S., John, S., Jabbar, K. & John, I. You can also search for this author in PubMed Thus, antibody therapy (bamlanivimab and etesevimab) in positively tested, non-hospitalized patients demonstrated that treatment resulted in decreased SARS-CoV-2 viral load by log100.57 on day 11, which was significantly greater compared to placebo (p=0.01)33. Rev. 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. Both descriptive and exploratory statistics were performed. Outpatients visiting Corona test centres were informed about the possibility of participating in the trial. 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). Kalle Saksela, MD, PhD, virologist, University of Helsinki, Nature Communications: Intranasal trimeric sherpabody inhibits SARS-CoV-2 including recent immunoevasive Omicron subvariants.. Sin. 6). The liquid contains NO at 0.11 ppm*hour, which acts as a viricidal agent. Viruses 12, 1384. https://doi.org/10.3390/v12121384 (2020). 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 . Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. On Day 8, 5 of the 27 (18.5%) and 6 of the 28 (21.4%) patients in the 0.1% azelastine and 0.02% azelastine groups, respectively were negative for the ORF1a/b gene, compared to the 0 of 26 patients in the placebo group. If all goes well, the hope is that we'll have a safe and effective nasal spray to serve as an extra line of defense in the fight against COVID-19. Comparable numbers of adverse events occurred in all treatment groups with no safety concerns. 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. https://doi.org/10.1021/acsmedchemlett.0c00521 (2020). 17(2), 19. Kim, M.-C. et al. Liu, L. et al. A phase 1 study for IGM-6268 is still taking place, and it's expected to be finished by December 2022. A study of frontline workers is looking into how a Boots nasal spray could prevent Covid-19. Article Chem. Quantifying the relationship between SARS-CoV-2 viral load and infectiousness. 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. 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). Of note, pharmacometric analyses of our data indicate that more frequent applications of the nasal spray may be more appropriate for efficient treatment35. Preliminary results of the current study have been published as preprint15. Pharmacometric modeling of the impact of azelastine nasal spray on SARS-CoV-2 viral load and related symptoms in COVID-19 patients. Therefore, the primary analysis for the viral loads was conducted non-parametrically. Boots Dual Defence Nasal Spray Family Bundle - 4 x 20ml Boots Dual Defence Nasal Spray Family Bundle - 4 x 20ml 20.00 Save 3.96 Worth 23.96 when bought separately 1486004 Maximum quantity reached Add to basket Add to favourites Collect 80 Boots Advantage Card points with this purchase Product details In this bundle: The sprays would be fast-acting and would be applied frequently, perhaps once or. Similarly, when given 2 or 4 hours after SARS-CoV-2 had already infected the epithelium, TriSb92 was linked to a complete lack of the virus's RNA in the lungs. Simon, M. W. The efficacy of azelastine in the prophylaxis of acute upper respiratory tract infections. Since the start of the COVID-19 pandemic, its treatment via the nasal route has been studied for a range of drugs17. IGM-6268. P.A.de.A., H.M. and H.A.S. More information about the results of the study, which was funded in part by NIAID. The hope is the vaccines will build immunity in one spot the coronavirus often invades . First report on a double-blind placebo-controlled phase II clinical trial. ISSN 1476-4687 (online) 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., . 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 Thus, it should be kept in mind that treatment started at a time point where the peak of viral load had probably passed. 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. https://doi.org/10.1007/s11224-020-01605-w (2020). 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. 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. https://doi.org/10.1038/s41586-021-04388-0 (2022). Whether the current data can be extrapolated to other SARS-CoV-2 variants needs to be investigated. Comirnaty is also authorized . The independent 25 variable was the nasal carriage of Bacillus species. Identification of SARS-CoV-2 entry inhibitors among already approved drugs. 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. ITTintention to treat. Patient disposition. Comirnaty may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19. C.A. Get the most important science stories of the day, free in your inbox. The improvement of the symptom shortness of breath was significantly greater on days 3 (p=0.004) and 4 (p=0.011) in the 0.1% azelastine group compared to placebo (supplementary Figure S3). Studies into Xlear's antiviral effects on SARS . A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic. 27, 790792. 4). Google Scholar. 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). Intern. A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic. Amdal, C. D. et al. Ann. 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). Mice treated with just a single dose of N-0385 on the day they were infected had a high survival rate as well. 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. Three-group comparisons were analysed with KruskalWallis test. Commun. Overall, no significant differences were observed between treatment groups regarding gender, age and body mass index (bmi, supplementary Table S1). Pharmacol. Pharmacol. The researchers first tried one dose a day for seven days, starting a day before SARS-CoV-2 infection. Within the subgroup of patients with baseline Ct values below 25, a similar progression of viral load data was observed (Fig. Overall, none of the participating patients had clinically relevant increased values of body temperature (data not shown). Virol. ISSN 2045-2322 (online). New research has answers, COVID's future: mini-waves rather than seasonal surges, Are repeat COVID infections dangerous? Sci. https://doi.org/10.1038/s41586-020-2196-x (2020). were involved in data management. Nasopharyngeal swabs were obtained by investigators using nylon-flocked swabs (Biocomma; SW01E, flexible minitip, Biocomma, Shenzen, China). Correspondence to De Vries, R. D. et al. Rep. 117 https://doi.org/10.1007/s43440-023-00463-7. and B.S. Expert. contributed to the study conceptualisation. Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients. 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
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