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. You are using a browser version with limited support for CSS. 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). 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. Reznikov et al. 1). JPK and CL have received grants from the sponsor URSAPHARM Arzneimittel GmbH for performing this trial. Anticipating a drop-out rate of 20%, the aim was to randomize 90 patients in total (30 patients per treatment group) to result in 23 patients per treatment group completing the study and being eligible for analysis. It would be desirable to extend the investigation of azelastine nasal spray as potential antiviral treatment with in vitro culture experiments. PubMed It would be desirable to use a validated, COVID-19 specific questionnaire in future studies, and first attempts for its development are promising32. Ctcycle threshold. Samples of day 1 represent pre-treatment baseline samples. Povidone iodine mouthwash, gargle, and nasal spray to reduce nasopharyngeal viral load in patients with COVID-19: A randomized clinical trial. 90 patients were recruited between 09/03/2021 and 28/04/2021, constituting the safety analysis set. Striking antibody evasion manifested by the Omicron variant of SARS-CoV-2. Our study showed both strengths and limitations. 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. Comirnaty is FDA-approved as a 2-dose series for the prevention of COVID-19 in individuals 12 years of age and older. 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. A nasal and mouth spray called "IGM-6268" is in the early stages of clinical trials. Drug Resist. Investigators and trial participants were masked to the treatment as investigational medicinal products were identical in appearance. CAS Study endpoints were presented by descriptive statistics, aiming to compare the course of viral load between the three treatment groups. 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. Inhibition of SARS-CoV-2 by bentonite-based nasal spray. Article and JavaScript. SRT was originally developed in 2009 by Dr. Thomas Hummel at the University of Dresden. 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. Ann. Mitze, T. & Rode, J. Early-stage spatial disease surveillance of novel SARS-CoV-2 variants of concern in Germany with crowdsourced data. 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. It's being studied as a potential way to prevent mild to moderate cases of COVID-19. Levine-Tiefenbrun, M. et al. Patient Rep. Outcomes 6, 26. https://doi.org/10.1186/s41687-022-00434-1 (2022). Investigators assessed patients status throughout the trial including safety follow-ups (days 16 and 60). analyzed 219,000 medical records in a retrospective data base survey study and demonstrated that azelastine showed the highest association between prior usage among these antihistamines and SARS-CoV-2 negative test results in patients above the age of 60 (OR: 2.43; 95% CI: 1.474.02). Elife 10, e69302. 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. In the meantime, to ensure continued support, we are displaying the site without styles Nasal steroid sprays may reduce the severity of COVID-19, according to a new study. Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: A randomized clinical trial. 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. Article TriSb92 could effectively tip the balance in favor of the [the person] and thereby help to reducethe risk of severe COVID-19 disease, she said.. Mice treated with just a single dose of N-0385 on the day they were infected had a high survival rate as well. To infect a cell, the virus tricks several of that cells proteins, including one called TMPRSS2, to gain entry. J.P.K. How nasal-spray vaccines could change the pandemic, How much virus does a person with COVID exhale? 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. 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. It also appears to . Components are mixed from two chambers to create the final NO-producing formulation. Thus, eligibility criteria were designed carefully to investigate a clearly defined, homogeneous study population of low-risk patients with a narrow age range. Vitiello, A., Ferrara, F., Troiano, V. & La Porta, R. COVID-19 vaccines and decreased transmission of SARS-CoV-2. 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%. Early intervention with azelastine nasal spray may reduce viral load in SARS-CoV-2 infected patients. 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. Nature (Nature) 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. Viruses 13, 895. https://doi.org/10.3390/v13050895 (2021). Cegolon, L. et al. These devices release a low-velocity aerosol mist that can be slowly inhaled over a longer period of time than metered dose and dry powder inhalers. Data was analysed primarily exploratively; there was no formal testing of a given hypothesis. The company led byMkel is now working to secure funding for clinical trials of TriSb92 in humans.. Upon treatment, a gradual decline of viral load from baseline (day 1) to day 11 of treatment was observed in all three study groups. When given in advance, none of the treated mice had SARS-CoV-2 RNA in their lungs, while untreated mice in the comparison group had abundant levels. Chem. Subgroups were analysed exploratorily (e.g., subgroups regarding gender, age, symptom severity, etc.). Scientific Reports (Sci Rep) The study was termed CARVIN (referring to COVID-19: Azelastine nasal spray Reduces Virus-load In Nasal swabs). Early negativization of SARS-CoV-2 infection by nasal spray of seawater plus additives: The RENAISSANCE open-label controlled clinical trial. Jain, R. & Mujwar, S. Repurposing metocurine as main protease inhibitor to develop novel antiviral therapy for COVID-19. SARS-CoV-2 infection progression starts with viral entrance mediated by the spike glycoproteins interaction with the host ACE2 receptor molecule. https://doi.org/10.1007/s11739-021-02786-w (2021). This is similar to the natural SARS-CoV-2 clearance time of approximately 2weeks. The WHO clinical progression scale progressively decreased in all treatment groups during the study. 62, 50937, Cologne, Germany, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne, Kerpener Str. Ghahremanpour et al. We would like to thank Prof. G.A. . 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. From hydroxychloroquine and veterinarian doses of the antiparasitic drug ivermectin, questionableand potentially harmfultreatments for COVID-19 have circulated the internet. Performance of self-collected saliva testing compared with nasopharyngeal swab testing for the detection of SARS-CoV-2. Simon, M. W. The efficacy of azelastine in the prophylaxis of acute upper respiratory tract infections. 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. Comirnaty is the FDA-approved monovalent COVID-19 (coronavirus 2019) vaccine made by Pfizer for BioNTech. During visits, nasopharyngeal swabs were taken for quantitative PCR measurements, and investigators assessed the patient status in accordance with the WHO clinical progression scale11. 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). 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%. Those parameters were based on the COVID-19 symptoms published by the Robert Koch Institute (https://www.rki.de) at the time of the study. Receive 51 print issues and online access, Get just this article for as long as you need it, Prices may be subject to local taxes which are calculated during checkout, doi: https://doi.org/10.1038/d41586-022-03341-z. 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. 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 8, e70. Both descriptive and exploratory statistics were performed. 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). Antiviral efficacy was observed at an EC50 of~6M, which is an approximately 400-fold lower concentration compared to commercially available azelastine nasal sprays. The spritz developed by Moscona's team is one of a raft of proposed nasal sprays to prevent SARS-CoV-2 infection. 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. Continuous data were described by statistical estimates (mean, standard deviation, median, minimum, and maximum values). This same site is shared among many variants of the COVID virus, so it could be effective against future variants as well, researchers note. If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate. Google Scholar. Yang, L. et al. Soft mist inhalers are propellant-free devices that are slightly larger than conventional metered dose inhalers. C.L. After treatment, virus load was reduced in all groups (p<0.0001) but was greater in the 0.1% group compared to placebo (p=0.007). 10, 294. https://doi.org/10.3389/fphar.2019.00294 (2019). Comirnaty is also authorized . Nasal sprays may be a promising first line of defense against SARS-CoV-2 infection. Pharmaceutics 14, 2059. https://doi.org/10.3390/pharmaceutics14102059 (2022). CAS https://doi.org/10.1038/s41591-022-01780-9 (2022). JAMA Otolaryngol. ISSN 2045-2322 (online). Information on individual variants was obtained through the original laboratory reports, when available. 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. Will there be a COVID winter wave? Kim, M.-C. et al. Wlfel, R. et al. . Since the start of the COVID-19 pandemic, its treatment via the nasal route has been studied for a range of drugs17. Negative PCR results appeared earlier and more frequently in the azelastine treated groups: being 18.52% and 21.43% in the 0.1% and 0.02% groups, respectively, compared to 0% for placebo on day 8. As expected, a continuous decrease in the mean virus load was observed in all study groups during the 11 treatment days. A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic. 62, 50937, Cologne, Germany, German Center for Infection Research (DZIF) Location Bonn-Cologne, Kerpener Str. 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. Article De Vries, R. D. et al. 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. Pediatr. 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. Der deutsche SF-36 health survey bersetzung und psychometrische testung eines krankheitsbergreifenden instruments zur erfassung der gesundheitsbezogenen lebensqualitt. 19(10), 16. https://doi.org/10.7554/eLife.69302 (2021). But vaccines are fighting a changing opponent. https://doi.org/10.1001/jamaoto.2020.5490 (2021). 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). Patients aged 18 to 60years were eligible to participate if tested positive for SARS-CoV-2 in a Corona test centre by PCR test within 48h prior to inclusion and had to quarantine at home due to instructions of the local health authority. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiological . Antiviral activity was subsequently verified in cell culture. This observational study (HUN-VE: Hungarian Vaccine Effectiveness) estimated vaccine effectiveness against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and COVID-19-related mortality in 3.7 million . ADS Furthermore, three independent groups predicted interaction of azelastine hydrochloride with the main protease of SARS-CoV-2: main protease (Mpro) or 3C-like cysteine protease (3CLpro)7,8,9. By application of a novel computational approach based on Shannon entropy homology, Konrat et al. Mutations in spike allow the virus to evade the immune system as well as therapies designed to target it. New research has answers, COVID's future: mini-waves rather than seasonal surges, Are repeat COVID infections dangerous? One puff of the respective nasal spray was applied per nostril, 3 times a day (morning, midday, evening). 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. Comparable numbers of adverse events occurred in all treatment groups with no safety concerns. COVID-19 Get the latest information from the CDC about COVID-19. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. PubMed Pharmacometric modeling of the impact of azelastine nasal spray on SARS-CoV-2 viral load and related symptoms in COVID-19 patients. Patient reported outcomes were documented by patient diaries and questionnaires. And she wished she could feel confident that she could see her immunocompromised relatives without inadvertently spreading the novel coronavirus to them. Nasal defence sprays Products such as Vicks First Defence nasal spray claim to trap and neutralise viruses in the nose before they have a chance to develop and spread. Chem. The hope is the vaccines will build immunity in one spot the coronavirus often invades . Virol. Both have the allure of being variant-proof, Topol added., Many laboratories are shifting from treatments using monoclonal antibodies to treatments using smaller antibody fragments called "nanobodies" because they are more cost-effective and are able to last longer in storage, Mkel and colleagues noted., Several of these nanobodies have shown promise against viruses in cell culture or animal models, including as an intranasal preventive treatment for SARS-CoV-2.. To obtain and JavaScript. https://doi.org/10.1038/s41598-023-32546-z, DOI: https://doi.org/10.1038/s41598-023-32546-z. For clarity reason, only cp/mL values of the ORF 1a/b gene are shown in the main text of the manuscript. contributed to the study conceptualisation. 00:00. HG, MS, and FK declare no conflict of interest. A phase 1 study for IGM-6268 is still taking place, and it's expected to be finished by December 2022. In the meantime, to ensure continued support, we are displaying the site without styles The antiviral also could offer an alternative to people who cannot or do not respond to a vaccine. https://doi.org/10.1080/14787210.2021.1908127 (2021). KaplanMeier survival analyses underlined those findings, indicating that mean times of a PCR result to turn negative was 9.96days (95% CI: 9.0210.90) in the 0.1% azelastine group, 10.21days (95% CI: 9.5710.86) in the 0.02% azelastine group and 11.00 (95% CI: 10.0010.77) in the placebo group (Fig. Comirnaty may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19. Shapira, T., Monreal, I. Rev. Article Lee, C. & Corren, J. Asthma Allergy Immunol. reviewed, edited and finalised the manuscript. When treated with N-0385, 70% of the mice survived and had little to no lung damage. Nasopharyngeal swabs were obtained by investigators using nylon-flocked swabs (Biocomma; SW01E, flexible minitip, Biocomma, Shenzen, China). Google Scholar. Loading Twitter content. 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). Thank you for visiting nature.com. 24 COVID-19 status classified as negative, asymptomatic, mild, or severe. Nature 602, 676681. 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. Initial report of decreased SARS-CoV-2 viral load after inoculation with the BNT162b2 vaccine. https://doi.org/10.1016/j.jinf.2021.05.009 (2021). The surface of SARS-CoV-2, the virus that causes COVID-19, is covered with spike proteins. Assuming a pooled standard deviation of =3 units, a two-sided =0.05 and a power of 90%, a sample size of 23 patients per treatment group was calculated. Patients of the current trial were eligible upon positive PCR test results, and if enrolled no later than 48h after swab sampling. 538, 173179. 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. 2005 - 2023 WebMD LLC, an Internet Brands company. These latch onto ACE2 receptors on human cells, allowing the virus to enter and infect the cells. https://doi.org/10.1021/acsmedchemlett.0c00521 (2020). Google Scholar. https://doi.org/10.1038/s41591-021-01316-7 (2021). To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Symptoms were documented in patient diaries. The trial medication (placebo nasal spray, 0.02% azelastine nasal spray or 0.1% azelastine nasal spray (the latter being identically composed as the commercial anti-allergic product Pollival) was manufactured at URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany). It can be used to help return your sense of smell if it was lost during a viral infection or minor head trauma. 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. Sin. 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.. Trial registration: The study was registered in the German Clinical Trial Register (DRKS-ID: DRKS00024520; Date of Registration in DRKS: 12/02/2021). 8, 701709. For hygiene reasons, it is preferable not to share the same nasal spray with other people. 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). Rep. 117 https://doi.org/10.1007/s43440-023-00463-7. To obtain You are using a browser version with limited support for CSS. Scientists are working on fast-acting nasal sprays to block coronavirus infections but formulating the sprays is a challenge. https://doi.org/10.1016/s1473-3099(20)30483-7 (2020). 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. was responsible for data management activities. The reduction in the symptom score was clinically relevant for all three groups. performed the statistical analysis. Vincenzo Messina, Riccardo Nevola, Luigi Elio Adinolfi, Kara W. Chew, Carlee Moser, Davey M. Smith, Manaf AlQahtani, Nitya Kumar, Stephen L. Atkin, V. Spagnuolo, M. Guffanti, COVID-BioB study group, Manish C. Choudhary, Kara W. Chew, for the ACTIV-2/A5401 Study Team, Emma Pritchard, Philippa C. Matthews, Koen B. Pouwels, Vineet Agarwal, A. J. Venkatakrishnan, Venky Soundararajan, Pauline Maisonnasse, Jrmie Guedj, Roger Le Grand, Scientific Reports Emerg. Importantly, newly emerging virus variants have the potential to evade the immune response, thereby affecting the efficacy of specific therapies and underlining the importance of new treatment strategies. Google Scholar. 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. In a study funded by NIAID, researchers are using mice to look for genes that account for different COVID-19 symptoms. During the course of the treatment, all study groups showed clear improvements of symptoms (Fig. https://doi.org/10.1089/088318703322751327 (2004). Molecular docking and dynamics simulation of FDA approved drugs with the main protease from 2019 novel coronavirus. 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. Amdal, C. D. et al. The reduction in virus load over the entire treatment period was clinically meaningful for all three groups (p<0.0001 for both genes). Future studies will help understanding the impact of azelastine hydrochloride in treating SARS-CoV-2 infected patients. 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. Article The researchers first tried one dose a day for seven days, starting a day before SARS-CoV-2 infection. Cornell research team to develop COVID-19 nose spray treatment. Smell retraining therapy (SRT) is a treatment for loss of smell, also referred to as hyposmia or anosmia. 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. Anti. PubMed The experimental drug works in mice, and researchers believe it may be effective in humans. Recently, Shmuel et al. Eric Topol, MD, director and founder, Scripps Research Translational Institute, La Jolla, CA; editor-in-chief, Medscape. Initial viral loads were log10 6.851.31 (meanSD) copies/mL (ORF 1a/b gene). 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.
Different Verbs For Closing A Door,
Abandoned Places In Biloxi, Ms,
The Woods At Laurel Brick, Nj,
Articles D
