Pujadas, E. et al. Will there be a COVID winter wave? 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. Expert. A nasal and mouth spray called "IGM-6268" is in the early stages of clinical trials. By application of a novel computational approach based on Shannon entropy homology, Konrat et al. To evaluate the total load during the study, AUC was calculated using a linear equation. 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. Of note, the mean viral load value showed small variability, thereby supporting the power of the current study. Overall, none of the participating patients had clinically relevant increased values of body temperature (data not shown). Importantly, this scenario corresponds to current COVID-19 treatment regimens (e.g., with monoclonal antibodies or antiviral substances), which are usually started at57days upon start of symptoms but are still efficacious. 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., . 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. PubMed Central Now, researchers at Swansea University will test it against Covid-19. KaplanMeier survival analyses with log-rank test were performed to display the occurrence of negative PCR test results upon treatment. https://doi.org/10.1001/jamaoto.2020.5490 (2021). 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. A complete list of inclusion and exclusion criteria is presented in Table 1. Researchers found that for people who regularly used a prescription corticosteroid like Beconase or Nasonex before getting sick with COVID-19, the risk of severe outcomes like hospitalization and death dropped by as much as 25%. 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. Smell retraining therapy (SRT) is a treatment for loss of smell, also referred to as hyposmia or anosmia. 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. 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. Nat. A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic. https://doi.org/10.1056/NEJMc2027040 (2021). 31(6), 113. 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. 24 COVID-19 status classified as negative, asymptomatic, mild, or severe. Because we get infected with SARS-CoV-2 primarily by breathing it in, a nasal spray might be an easy and efficient way to offer protection against the virus, especially in crowded places. 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. During the treatment phase, 7 visits (V1V7) took place on days 1, 2, 3, 4, 5, 8 and 11. Yang, L. et al. Nature, 10.1038/s41586-022-04661-w. Advance online publication. 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. Med. Quantifying the relationship between SARS-CoV-2 viral load and infectiousness. 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). Resource-efficient internally controlled in-house real-time PCR detection of SARS-CoV-2. Google Scholar. 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. 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. This was a prospective, randomized, double-blind, placebo-controlled dose-finding proof-of-concept study, in which azelastine nasal spray was used in 2 doses: the commercially available concentration of 0.1% and a fivefold lower concentration of 0.02%. 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 It can be used to help return your sense of smell if it was lost during a viral infection or minor head trauma. 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. 4). 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. Article Front. Patients were visited and tested at home on regular basis by the investigators, physicians specialised in otorhinolaryngology, medical hygiene, or general medicine. The researchers first tried one dose a day for seven days, starting a day before SARS-CoV-2 infection. CAS 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 . R.M., S.M.S., S.A. and P.M. designed the study protocol. Infect. Watts, A. M., Cripps, A. W., West, N. P. & Cox, A. J. Modulation of allergic inflammation in the nasal mucosa of allergic rhinitis sufferers with topical pharmaceutical agents. Thank you for visiting nature.com. were involved in data management. Article 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. Nature 581, 465469. Viral load and disease severity in COVID-19. On days 1, 5, 8 and 11, patients completed the standardized SF-36 questionnaire of quality of life. 1). Google Scholar. To obtain IGM-6268. 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. The current study demonstrated a gradual decrease of patients symptoms and improvements of quality of life. De Vries, R. D. et al. Biochem. Marc, A. et al. Early intervention with azelastine nasal sprays reduces viral load in SARS-CoV-2 infected patients. Bearing in mind that viral load might be a surrogate measure of infectiousness, those results are encouraging as they indicate that azelastine may be a promising candidate for preventing the spread of this disease. Future studies will help understanding the impact of azelastine hydrochloride in treating SARS-CoV-2 infected patients. 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. To infect a cell, the virus tricks several of that cells proteins, including one called TMPRSS2, to gain entry. 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 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. During the throes of the COVID-19 pandemic, Anne Moscona didnt feel safe going to a restaurant or catching a flight. 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. Overall, no statistical differences between groups were determined. All rights reserved. ITTintention to treat. 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 . Google Scholar. Researchers are developing coronavirus vaccines that will be sprayed up the nose. Mitze, T. & Rode, J. Early-stage spatial disease surveillance of novel SARS-CoV-2 variants of concern in Germany with crowdsourced data. 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. From hydroxychloroquine and veterinarian doses of the antiparasitic drug ivermectin, questionableand potentially harmfultreatments for COVID-19 have circulated the internet. 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. The company led byMkel is now working to secure funding for clinical trials of TriSb92 in humans.. When the treatment course was shortened to four days, starting one day before infection, all 10 of the mice treated with N-0385. Jain, R. & Mujwar, S. Repurposing metocurine as main protease inhibitor to develop novel antiviral therapy for COVID-19. 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. was responsible for data management activities. All nasal sprays were composed of hypromellose, disodium edetate, citric acid, disodium phosphate dodecahydrate, sodium chloride and purified water. We acknowledge support for the Article Processing Charge from the DFG (German Research Foundation, 491454339). Clinical efficacy of nitric oxide nasal spray (NONS) for the treatment of mild COVID-19 infection. Shapira, T., Monreal, I. This is exemplified by the emergence of the highly immune evasive omicron variant that is resistant to many monoclonal antibodies authorized for clinical use34. 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). Continuous data were described by statistical estimates (mean, standard deviation, median, minimum, and maximum values). 538, 173179. 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. Our study showed both strengths and limitations. It would be desirable to use a validated, COVID-19 specific questionnaire in future studies, and first attempts for its development are promising32. 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). Guenezan, J. et al. Researchers supported in part by the National Institute of Allergy and Infectious Diseases (NIAID) have developed a nasal spray that has the potential to not only treat COVID-19 but also prevent SARS-CoV-2 infection in a way that the virus cant mutate to avoid. Rep. 117 https://doi.org/10.1007/s43440-023-00463-7. The sprays generally require multiple doses per day, whereas a single dose of a nasal vaccine may protect for months, he said. 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. 18, 110. https://doi.org/10.1186/s12985-021-01559-3 (2021). Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults. Investigators and trial participants were masked to the treatment as investigational medicinal products were identical in appearance. 19(10), 16. SRT was originally developed in 2009 by Dr. Thomas Hummel at the University of Dresden. Patients had to daily document their COVID-19 specific symptoms in an electronic patient diary. "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. At the end of the study, patients and investigators assessed the overall tolerability and efficacy of the treatment as very good (3), good (2), moderate (1) or poor (0). was responsible for the patient disposition. When the treatment course was shortened to four days, starting one day before infection, all 10 of the mice treated with N-0385 survived. Cite this article. Since the start of the COVID-19 pandemic, its treatment via the nasal route has been studied for a range of drugs17. 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. 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. Categorical data were described by absolute frequencies and percentage of valid cases. FH is the CEO of URSAPHARM Arzneimittel GmbH. 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. The anti-histamine azelastine, identified by computational drug repurposing, inhibits infection by major variants of SARS-CoV-2 in cell cultures and reconstituted human nasal tissue. Lett. The independent 25 variable was the nasal carriage of Bacillus species. 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). The researchers first tried one dose a day for seven days, starting a day before SARS-CoV-2 infection. Associate Professor Peter Friedland, from UWA's Medical School, was lead author of the study In vivo . Center for Molecular Medicine Cologne (CMMC), Faculty of Medicine and University Hospital, University of Cologne, Kerpener Str. 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. and B.S. https://doi.org/10.1038/s41598-023-32546-z, DOI: https://doi.org/10.1038/s41598-023-32546-z. 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. The most promising compound, N-0385, virtually stopped infection in its tracks.
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