The reduction in the symptom score was clinically relevant for all three groups. 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. Winchester, S., John, S., Jabbar, K. & John, I. Jean, F. (2022). COVID-19 Get the latest information from the CDC about COVID-19. 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. J. 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. https://doi.org/10.1038/s41591-022-01780-9 (2022). Chem. 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). 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. Azelastine hydrochloride nasal spray is an approved medicinal product currently available at a concentration of 0.1% w/v to treat allergic rhinitis. The shown effects of azelastine nasal spray may thus be suggestive of azelastines potential as an antiviral treatment. 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. BR, SMS, HS, CA, NW, SA, and RM are employees of ClinCompetence Cologne, the CRO which organized this trial. The experimental drug works in mice, and researchers believe it may be effective in humans. https://doi.org/10.1038/s41598-023-32546-z, DOI: https://doi.org/10.1038/s41598-023-32546-z. A pilot study of 0.4% povidone-iodine nasal spray to eradicate SARS-CoV-2 in the nasopharynx. 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. The current study was a randomized, parallel, double-blind, placebo-controlled trial. Viruses 12, 1384. https://doi.org/10.3390/v12121384 (2020). 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. 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. 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. Overall, data of the primary outcome did not show a normal distribution (ShapiroWilk test, p<0.05). 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. Pediatr. Resource-efficient internally controlled in-house real-time PCR detection of SARS-CoV-2. 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. 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). 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. It's a type of antibody that targets the coronavirus' spike protein. During visits, nasopharyngeal swabs were taken for quantitative PCR measurements, and investigators assessed the patient status in accordance with the WHO clinical progression scale11. A summary of study activities is displayed in Table 2. During the course of the treatment, all study groups showed clear improvements of symptoms (Fig. 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. Struct. Comirnaty is FDA-approved as a 2-dose series for the prevention of COVID-19 in individuals 12 years of age and older. Nasal sprays may be a promising first line of defense against SARS-CoV-2 infection. 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. When treated with N-0385, 70% of the mice survived and had little to no lung damage. The team will enrol 480 healthworkers, including nurses and doctors . Study endpoints were presented by descriptive statistics, aiming to compare the course of viral load between the three treatment groups. 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. Scientific Reports (Sci Rep) The Coronavirus Immunotherapy Consortium identified new candidate drugs based on monoclonal antibodies in work funded by NIAID. . 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 . EudraCT number: 2020-005544-34. Sin. 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. Biophys. A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic. It can be used to help return your sense of smell if it was lost during a viral infection or minor head trauma. Res. Cite this article. On day 16, an on-site visit (V8) for female patients was conducted to perform a urine pregnancy test and to assess the safety of the therapy. Additionally, safety follow-ups were performed at 2 time-points. In addition, investigators measured body temperature during V1V7 and oxygen saturation of the blood (using a finger pulse oximeter) on V1, V3, and V5, V6 and V7. All nasal sprays were composed of hypromellose, disodium edetate, citric acid, disodium phosphate dodecahydrate, sodium chloride and purified water. Trial registration: The study was registered in the German Clinical Trial Register (DRKS-ID: DRKS00024520; Date of Registration in DRKS: 12/02/2021). 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 Patients were assigned a treatment number in an ascending mode according to their chronological order of inclusion. Ct values reported as negative were replaced with the value 45, and respective cp/mL values with the value 1, and cp/mL values<2116 (ORF 1a/b gene) and cp/mL values<1950 (E gene) were replaced with the value 1. Correspondence to 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. Public Health 3, 21. https://doi.org/10.1007/BF02959944 (1995). 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.. Pharmacol. Article It would be desirable to use a validated, COVID-19 specific questionnaire in future studies, and first attempts for its development are promising32. https://doi.org/10.6026/97320630016236 (2020). 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. You are using a browser version with limited support for CSS. Identification of antiviral antihistamines for COVID-19 repurposing. Bioinformation 16, 236244. Klussmann, J.P., Grosheva, M., Meiser, P. et al. 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. 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). Following translocation from nucleus to the endoplasmic reticulum (ER), the sigma-1 receptor (among other factors) plays a role in viral replication. Google Scholar. Killingley, B. et al. https://doi.org/10.1089/088318703322751327 (2004). A study of frontline workers is looking into how a Boots nasal spray could prevent Covid-19. Provided by the Springer Nature SharedIt content-sharing initiative. EN, VS and GN are shareholders in CEBINA GmbH, RK and EN are inventors on related patent applications. It has been suggested that azelastine can inhibit the entry of the SARS-CoV-2 into the nasal mucosa by binding to the ACE2 receptor and also act via binding to the main protease of SARS-CoV-2 and to the host cells sigma-1 receptor, therewith facilitating both viral entry and replication-inhibiting effects6,9. Guenezan, J. et al. 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. Researchers began to work on compounds that stifle TMPRSS2s ability to interact with the viral protein. 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. . ITTintention to treat. 8, e70. The antiviral also could offer an alternative to people who cannot or do not respond to a vaccine. China and India approve nasal COVID vaccines are they a game changer? was the deputy investigator. 62, 50937, Cologne, Germany, German Center for Infection Research (DZIF) Location Bonn-Cologne, Kerpener Str. Researchers plan to continue testing the timing of when N-0385 should be administered and to expand testing into human clinical trials. ICE-COVID, will investigate whether Dual Defence can either prevent Covid-19 infection or reduce . Our study showed both strengths and limitations. The reduction of the symptom score from baseline to day 11 was 8.389.42 in the 0.02% azelastine group and 11.129.45 in the placebo group. Smell Retraining Therapy. For pairwise comparisons between treatment groups, Mann Whitney U test was performed, and significance levels were adjusted to p<0.0167 based on the Bonferroni correction.
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