Now, researchers at Swansea University will test it against Covid-19. 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. A complete list of inclusion and exclusion criteria is presented in Table 1. Xylitol Based Nasal Spray for COVID-19 Treatment Pediatr. 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. 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. Subgroups were analysed exploratorily (e.g., subgroups regarding gender, age, symptom severity, etc.). Upon treatment, a gradual decline of viral load from baseline (day 1) to day 11 of treatment was observed in all three study groups. Those compounds were tested in human lung and colon cells that were then exposed to SARS-CoV-2. 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. was the principal investigator responsible for the conduct of the study, M.G. A summary of study activities is displayed in Table 2. PM, MF, DG, CS and BS are employed at URSAPHARM Arzneimittel GmbH. Correspondence to Chem. Nasal vaccines for COVID-19 offer hope and face hurdles - Science News 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. . Google Scholar. And she wished she could feel confident that she could see her immunocompromised relatives without inadvertently spreading the novel coronavirus to them. 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. Mitze, T. & Rode, J. Early-stage spatial disease surveillance of novel SARS-CoV-2 variants of concern in Germany with crowdsourced data. Commun. Early intervention with azelastine nasal sprays reduces viral load in SARS-CoV-2 infected patients. 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). The antiviral also could offer an alternative to people who cannot or do not respond to a vaccine. EudraCT number: 2020-005544-34. "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. FH is the CEO of URSAPHARM Arzneimittel GmbH. Treatment kits were manufactured by URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany, according to the randomization list (as sequentially numbered containers). Approval of the study by the German Federal Institute for Drugs and Medical Devices (BfArM) was given on 3rd February 2021. Preliminary results of the current study have been published as preprint15. Nature 602, 676681. 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. Importantly, the AUC analysis depicting the viral load decrease based on the detection of the ORF 1a/b gene over the 11-day treatment period showed a significantly greater reduction of virus load in the 0.1% azelastine group compared to placebo. BR, SMS, HS, CA, NW, SA, and RM are employees of ClinCompetence Cologne, the CRO which organized this trial. The Coronavirus Immunotherapy Consortium identified new candidate drugs based on monoclonal antibodies in work funded by NIAID. 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. We would like to thank Prof. G.A. 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). Of note, the mean viral load value showed small variability, thereby supporting the power of the current study. E.N., V.S., G.N., R.K., A.B., M.F. Shapira, T., Monreal, I. https://doi.org/10.1089/088318703322751327 (2004). 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. 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. 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. 3). In the meantime, to ensure continued support, we are displaying the site without styles Comparable numbers of adverse events occurred in all treatment groups with no safety concerns. Sign up for the Nature Briefing newsletter what matters in science, free to your inbox daily. The sprays would be fast-acting and would be applied frequently, perhaps once or. Inhibition of SARS-CoV-2 by bentonite-based nasal spray. The shown effects of azelastine nasal spray may thus be suggestive of azelastines potential as an antiviral treatment. Indeed, the majority of the study subjects carried this variant. Ghahremanpour, M. M. et al. The aim of our study was to support the preclinical evidence for azelastines antiviral activity in patients tested positive for SARS-CoV-2. Konrat, R. et al. Vitiello, A., Ferrara, F., Troiano, V. & La Porta, R. COVID-19 vaccines and decreased transmission of SARS-CoV-2. also provided experimental evidence for the inhibition of the enzyme in a kinetic activity assay7. 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.