The researchers compared mice treated with TriSb92 before and after exposure to SARS-CoV-2. This trial was conducted at the Department of Otorhinolaryngology, Head and Neck Surgery of the Faculty of Medicine of the University of Cologne, Germany. However, the overall small number of participants limits conclusions, and results should be interpreted with care. Virological assessment of hospitalized patients with COVID-2019. Vitiello, A., Ferrara, F., Troiano, V. & La Porta, R. COVID-19 vaccines and decreased transmission of SARS-CoV-2. Google Scholar. Slider with three articles shown per slide. Ethics approval was granted by the Ethics Committee of the Faculty of Medicine of Cologne University on the 10th of February 2021. As expected, a continuous decrease in the mean virus load was observed in all study groups during the 11 treatment days. JAMA Otolaryngol. 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. Simon, M. W. The efficacy of azelastine in the prophylaxis of acute upper respiratory tract infections. FH is the CEO of URSAPHARM Arzneimittel GmbH. Lee, K. (2022, April 27). https://doi.org/10.1001/jama.2021.0202 (2021). Nasopharyngeal swabs were obtained by investigators using nylon-flocked swabs (Biocomma; SW01E, flexible minitip, Biocomma, Shenzen, China). Med. Virol. 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). Asthma Allergy Immunol. Xlear have developed and patented a xylitol containing nasal spray for the treatment of upper-respiratory tract infections. 42, 17. 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. 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. Whereas PCR data of individual days served for daily comparisons between treatment groups, the area under the curve (AUC) value was used for the evaluation of the overall development of viral kinetics. and showed they could neutralize the SARS-CoV-2 virus. It also appears to . Further endpoints include infection. J.P.K. Thank you for visiting nature.com. Internet Explorer). Guenezan, J. et al. https://cornellsun.com/2022/04/27/cornell-research-team-to-develop-covid-19-nose-spray-treatment/, Shapira, T., Monreal, I. Molecular docking and dynamics simulation of FDA approved drugs with the main protease from 2019 novel coronavirus. Associate Professor Peter Friedland, from UWA's Medical School, was lead author of the study In vivo . Pharmaceutics 14, 2502. https://doi.org/10.3390/pharmaceutics14112502 (2022). By Dr. Ramya Dwivedi, Ph.D. Jul 19 2021. Since the start of the COVID-19 pandemic, its treatment via the nasal route has been studied for a range of drugs17. Preliminary results of the current study have been published as preprint15. 31(6), 113. Chem. The trial protocol and the data are however available from the authors upon reasonable request and with permission of URSAPHARM Arzneimittel GmbH. https://doi.org/10.1080/14787210.2021.1908127 (2021). Therefore, the primary analysis for the viral loads was conducted non-parametrically. 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. Bullinger, M., Kirchberger, I. 4). 24 COVID-19 status classified as negative, asymptomatic, mild, or severe. When treated with N-0385, 70% of the mice survived and had little to no lung damage. 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.. B.R. 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. The Coronavirus Immunotherapy Consortium identified new candidate drugs based on monoclonal antibodies in work funded by NIAID. The independent 25 variable was the nasal carriage of Bacillus species. The reduction in the symptom score was clinically relevant for all three groups. Antiviral activity was subsequently verified in cell culture. Nature, 10.1038/s41586-022-04661-w. Advance online publication. J. Med. Article 03:08. (2021) COVID-19: Azelastine nasal spray reduces virus-load in nasal swabs (CARVIN). 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. The aim of our study was to support the preclinical evidence for azelastines antiviral activity in patients tested positive for SARS-CoV-2. Bioinformation 16, 236244. was responsible for the patient disposition. The 0.02% azelastine group showed an AUC value of 22.6412.56, which was not significantly different from the placebo group (p=0.022, Fig. CAS Kim, M.-C. et al. Small differences were found with regard to age and bmi, which were both slightly higher in the azelastine 0.1% group (supplementary Table S1). Nineteen of those were common COVID-19 symptoms (shortness of breath [n=4], loss of smell [n=4], loss of taste [n=3], [muscle] weakness [n=2], tiredness/exhaustion [n=2], muscle ache, concentration impaired, headache, and cough). For data analysis, negative PCR results were replaced with the Ct value 45 and the cp/mL value 1, respectively. Carrouel, F. 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. Nature 602, 676681. https://doi.org/10.1016/s1081-1206(10)63465-5 (1996). 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). For calibration purposes of quantitative assessments, reference samples were included with each PCR run. 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). 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. 384, 671673. 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. PubMed Central While PCR results in the placebo group turned negative only on day 11 of treatment, individual patients of the 0.1% azelastine group already showed negative PCR test results from day 2 on. 8, e70. 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. These nanobodies and TriSb92 target a specific part of the coronavirus spike protein called the receptor-binding domain (RBD). Evaluation of AUC values (reflecting baseline adjusted decreases of viral load over 11days) showed that the 0.1% azelastine group exhibited a greater AUC value of 24.1413.12 (referring to greater decrease) compared to the placebo group with an AUC value of 18.894.70 (p=0.007, Fig. Viruses 12, 1384. https://doi.org/10.3390/v12121384 (2020). reported that a low pH hypromellose nasal powder spray containing common components of nasal sprays could reduce SARS-CoV-2 infection rates19. 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. New research has answers, COVID's future: mini-waves rather than seasonal surges, Are repeat COVID infections dangerous? https://doi.org/10.2147/idr.S391630 (2022). Treatment kits were manufactured by URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany, according to the randomization list (as sequentially numbered containers). Science 371, 13791382 (2021). 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. 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., . Duration of culturable SARS-CoV-2 in hospitalized patients with covid-19. 5) Of note, these differences were not statistically significant (p=0.112). JPK and CL have received grants from the sponsor URSAPHARM Arzneimittel GmbH for performing this trial. Infect. If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate. Researchers have looked for ways to prevent SARS-CoV-2 infection that the virus cant learn to dodge or evade by mutating. Article Mitze, T. & Rode, J. Early-stage spatial disease surveillance of novel SARS-CoV-2 variants of concern in Germany with crowdsourced data. You are using a browser version with limited support for CSS. Azelastine hydrochloride nasal spray is an approved medicinal product currently available at a concentration of 0.1% w/v to treat allergic rhinitis. But vaccines are fighting a changing opponent. Dual Defence Nasal Spray is an easy to use nasal spray containing clinically proven Carragelose to help shorten the duration and severity of cold and flu-like symptoms. 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. 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). What scientists say. Comirnaty is FDA-approved as a 2-dose series for the prevention of COVID-19 in individuals 12 years of age and older. Lee, C. & Corren, J. https://doi.org/10.1016/j.bbrc.2020.11.095 (2021). Lett. Elife 10, e69302. Nature 581, 465469. 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. Lancet Infect. performed and supervised sample processing and viral load measurements. also provided experimental evidence for the inhibition of the enzyme in a kinetic activity assay7. Overall, no statistical differences between groups were determined. Samples of day 1 represent pre-treatment baseline samples. We are aware that this limited the capture of COVID-19 specific issues as questions were not specifically aimed for COVID-19 patients. https://doi.org/10.7554/eLife.69302 (2021). WebMD does not provide medical advice, diagnosis or treatment. This could happen by limiting how much virus could replicate early in the skin inside the nose and nasopharynx (the upper part of the throat), saidMkel, who is also CEO of Pandemblock Oy, the company set up to develop the product. 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. PubMed Shapira, T. et al. 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. Following translocation from nucleus to the endoplasmic reticulum (ER), the sigma-1 receptor (among other factors) plays a role in viral replication. MG, PA, HM and HAS declare no conflict of interest. Of note, pharmacometric analyses of our data indicate that more frequent applications of the nasal spray may be more appropriate for efficient treatment35. Front. It would be desirable to use a validated, COVID-19 specific questionnaire in future studies, and first attempts for its development are promising32. PubMed Identification of antiviral antihistamines for COVID-19 repurposing. ISSN 0028-0836 (print). C.L. Overall, none of the participating patients had clinically relevant increased values of body temperature (data not shown). 4). 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 J. 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). On days 1, 5, 8 and 11, patients completed the standardized SF-36 questionnaire of quality of life. 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. 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. Symptoms were evaluated on a 5-point scale from 1=symptom absent or present very weakly to 5=symptom present very strongly: anosmia, ageusia, cough, sore throat, shortness of breath, coryza, general weakness, headache, aching limb, loss of appetite, pneumonia, nausea, abdominal pain, vomiting, diarrhea, conjunctivitis, rash, lymph node swelling, apathy, somnolence. Article P eople who receive a Covid booster dose in the UK next month will be among the first in the world to receive Moderna's dual-variant vaccine, which protects against two strains of the virus.But . Viral load and disease severity in COVID-19. Eric Topol, MD, director and founder, Scripps Research Translational Institute, La Jolla, CA; editor-in-chief, Medscape. 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. In addition, presence or absence of fever (38.0C) was documented daily (0=no fever, 3=fever). For hygiene reasons, it is preferable not to share the same nasal spray with other people. Nasal steroid sprays may reduce the severity of COVID-19, according to a new study. Cegolon, L. et al. JAMA 325, 632644. Whether the current data can be extrapolated to other SARS-CoV-2 variants needs to be investigated. After having given informed consent, patients tested positively for SARS-CoV-2 were examined to assess eligibility according to inclusion/non-inclusion criteria and subsequently randomized to one of the three study groups. 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. 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. 62, 50937, Cologne, Germany, German Center for Infection Research (DZIF) Location Bonn-Cologne, Kerpener Str. It's a type of antibody that targets the coronavirus' spike protein. https://doi.org/10.1038/s41598-023-32546-z, DOI: https://doi.org/10.1038/s41598-023-32546-z. 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. Following sampling, swabs were placed into 3mL Virus Transport Medium (VTM, Biocomma) and delivered to the laboratory as quickly as possible. 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). Marc, A. et al. Patient reported outcomes were documented by patient diaries and questionnaires. CAS Amdal, C. D. et al. Google Scholar. The study was termed CARVIN (referring to COVID-19: Azelastine nasal spray Reduces Virus-load In Nasal swabs). N.W. Odhar, H. A. et al. 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. By application of a novel computational approach based on Shannon entropy homology, Konrat et al. 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. Sin. ISSN 2045-2322 (online). By submitting a comment you agree to abide by our Terms and Community Guidelines. Since azelastine has been shown to inhibit viral replication by 99.9% in Vero E6 cell culture and in reconstituted human nasal tissue cultures, it was assumed that a reduction of 3-log in virus load would be seen within 3days in actively treated patients, while no effect on virus load reduction would be seen in placebo treated patients. 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. Pediatr. All nasal sprays were composed of hypromellose, disodium edetate, citric acid, disodium phosphate dodecahydrate, sodium chloride and purified water. Commun. At the end of the study (day 60), all except one single patient (placebo group) showed a score of 0. N. Engl. Scientific Reports (Sci Rep) Comparable numbers of adverse events occurred in all treatment groups with no safety concerns. The study was funded by URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany and CEBINA GmbH Vienna, Austria. 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). *p=0.005 comparing the decrease of viral load on day 4 in the 0.1% azelastine group (log10 1.901.03) compared to placebo (log10 1.050.70; p=0.005). 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.. In the meantime, to ensure continued support, we are displaying the site without styles Sci Rep 13, 6839 (2023). Clinical efficacy of nitric oxide nasal spray (NONS) for the treatment of mild COVID-19 infection. Nasal sprays may be a promising first line of defense against SARS-CoV-2 infection. Many elderly people as well asindividuals who are immunodeficient for various reasons do not respond to vaccines, and are in the need of other protective measures, said Kalle Saksela, MD, PhD, senior author of the study and a virologist at the University of Helsinki. 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. This same site is shared among many variants of the COVID virus, so it could be effective against future variants as well, researchers note. Reznikov, L. R. et al. Google Scholar. Thank you for visiting nature.com. Sirijatuphat, R., Leelarasamee, A., Puangpet, T. & Thitithanyanont, A. . 76, 469475. 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. Now, researchers at Swansea University will test it against Covid-19. Acta Pharmacol. 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 . 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 . Chem. Ralph Msges. 11, 25262533. Dings, C. et al. Three-group comparisons were analysed with KruskalWallis test. 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. 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. 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. Categorical data were described by absolute frequencies and percentage of valid cases. Get the most important science stories of the day, free in your inbox. The median/mean viral load value (ORF 1a/b gene) of the ITT analysis set at enrolment was log10 7.23/6.851.31 cp/mL (approximately 7 million viral copies per mL, the highest values being~540 million cp/mL). the epithelium, to recreate the first line of defense against respiratory viruses. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The mean bmi of participants was 24.915.27. Now, researchers at Swansea University will test it against Covid-19 Now, researchers at Swansea University. 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.. 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). . A nasal and mouth spray called "IGM-6268" is in the early stages of clinical trials. was the principal investigator responsible for the conduct of the study, M.G. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiological . and JavaScript. Symptoms were documented in patient diaries. 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. 6). About 388 participants were included in the study 00:00. 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. Cornell Daily Sun. Identification of 14 known drugs as inhibitors of the main protease of SARS-CoV-2. PubMed Similarly, no clinically relevant differences regarding blood oxygen saturation values were detected between groups (data not shown). Boots Dual Defence Nasal Spray is used to dampen the symptoms of cold and flu. All authors contributed to the preparation of the manuscript, read and approved the manuscript. 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