At the end of the study (day 60), all except one single patient (placebo group) showed a score of 0. 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%. *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). The study was termed CARVIN (referring to COVID-19: Azelastine nasal spray Reduces Virus-load In Nasal swabs). 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Comparable numbers of adverse events occurred in all treatment groups with no safety concerns. Analyses were done on the entire data set (ITT) as well as on a subset population with high viral load defined by baseline Ct values below 25 (Ct<25). "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. URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany is the sponsor of the clinical trial. 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. 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). Wlfel, R. et al. 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. What the science says, Racial inequalities deepened in US prisons during COVID, The WHO at 75: what doesnt kill you makes you stronger, White House to tap cancer leader Monica Bertagnolli as new NIH director, Massive mosquito factory in Brazil aims to halt dengue, Seeks to identify an outstanding Scientific Director to lead its Division of Preclinical Innovation (DPI) in Rockville, Maryland. 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. Lee, C. & Corren, J. Ralph Msges. Pharmacother. All tests were performed two-sided and the type 1 error () was set to 5%. 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. In addition, presence or absence of fever (38.0C) was documented daily (0=no fever, 3=fever). Following sampling, swabs were placed into 3mL Virus Transport Medium (VTM, Biocomma) and delivered to the laboratory as quickly as possible. Outpatients visiting Corona test centres were informed about the possibility of participating in the trial. Article Ann. 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. By blocking that access, compounds that target TMPRSS2 have the potential to be effective against both current and future variants. Pharmaceutics 14, 2502. https://doi.org/10.3390/pharmaceutics14112502 (2022). Of note, the mean viral load value showed small variability, thereby supporting the power of the current study. About 388 participants were included in the study 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. To obtain To evaluate the total load during the study, AUC was calculated using a linear equation. 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. ICE-COVID, will investigate whether Dual Defence can either prevent Covid-19 infection or reduce . Simon, M. W. The efficacy of azelastine in the prophylaxis of acute upper respiratory tract infections. R.M., S.M.S., S.A. and P.M. designed the study protocol. A nasal and mouth spray called "IGM-6268" is in the early stages of clinical trials. ISSN 2045-2322 (online). 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. CAS 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). (2021) COVID-19: Azelastine nasal spray reduces virus-load in nasal swabs (CARVIN). 2005 - 2023 WebMD LLC, an Internet Brands company. But vaccines are fighting a changing opponent. Article About 388 participants were included in the study Biophys. performed the statistical analysis. Infect. Head Neck Surg. Samples of day 1 represent pre-treatment baseline samples. https://doi.org/10.1038/s41586-020-2196-x (2020). The Sponsor designed a dual chamber nasal spray bottle for NORS administration. Expert Opin. Killingley, B. et al. also provided experimental evidence for the inhibition of the enzyme in a kinetic activity assay7. Povidone iodine mouthwash, gargle, and nasal spray to reduce nasopharyngeal viral load in patients with COVID-19: A randomized clinical trial. 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. N. Engl. COVID-19 vaccines teach the immune system to recognize a particular protein on SARS-CoV-2 that is known as the spike protein. D.G., C.S. Ethics approval was granted by the Ethics Committee of the Faculty of Medicine of Cologne University on the 10th of February 2021. At V1, a comparable distribution of patients with a score of 1 (14.8% in the 0.1% azelastine group, 14.3% in the 0.02% azelastine group and 23.1% in the placebo group) or 2 (85.2% in the 0.1% azelastine group, 85.7% in the 0.02% azelastine group and 76.9% in the placebo group) was observed. 62, 50937, Cologne, Germany, German Center for Infection Research (DZIF) Location Bonn-Cologne, Kerpener Str. Xlear have developed and patented a xylitol containing nasal spray for the treatment of upper-respiratory tract infections. All nasal sprays were composed of hypromellose, disodium edetate, citric acid, disodium phosphate dodecahydrate, sodium chloride and purified water. Upon treatment, a gradual decline of viral load from baseline (day 1) to day 11 of treatment was observed in all three study groups. 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. 4). Nasal steroid sprays may reduce the severity of COVID-19, according to a new study. The sprays generally require multiple doses per day, whereas a single dose of a nasal vaccine may protect for months, he said. Investigators assessed patients status throughout the trial including safety follow-ups (days 16 and 60). The independent 25 variable was the nasal carriage of Bacillus species. Assignment of the treatment with the investigational medicinal product in the different doses vs. placebo to each treatment number was performed in a centrally conducted, computer-generated 1:1:1 randomization procedure. Since the start of the COVID-19 pandemic, its treatment via the nasal route has been studied for a range of drugs17. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. Thus, it should be kept in mind that treatment started at a time point where the peak of viral load had probably passed. The liquid contains NO at 0.11 ppm*hour, which acts as a viricidal agent. Decreases of viral load were also reflected in increases of negative PCR results over time. Initial report of decreased SARS-CoV-2 viral load after inoculation with the BNT162b2 vaccine. Antiviral activity was subsequently verified in cell culture. The patient status was assessed at V1V7 and at V9 by the investigators with a 11-category ordinal score proposed by the WHO11. Download PDF Copy. SARS-CoV-2 viral load predicts COVID-19 mortality. Drug Resist. And she wished she could feel confident that she could see her immunocompromised relatives without inadvertently spreading the novel coronavirus to them. https://doi.org/10.1001/jama.2021.0202 (2021). was the deputy investigator. Lancet Respir. https://doi.org/10.1080/14787210.2021.1908127 (2021). The sample size calculation was based on the expected reduction of virus load during the treatment considering 3 treatment arms. https://doi.org/10.1038/s41586-022-04661-w. Read stories about the efforts underway to prevent, detect, and treat COVID-19 and its effects on our health. Ctcycle threshold. 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. You can also search for this author in PubMed 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. 147, 400401. Internet Explorer). Pediatr. identified azelastine as an anti-viral candidate and demonstrated pronounced anti-SARS-CoV-2 activity in vitro10. Resource-efficient internally controlled in-house real-time PCR detection of SARS-CoV-2. Sci Rep 13, 6839 (2023). Postdoctoral Associate- Immunology, T Cells, GVHD, Bone Marrow Transplantation, Postdoctoral Fellows in the VU Department of Biochemistry. Nasal antiviral blocks SARS-CoV-2 infection in mice, Finding Effective Treatments for SARS-CoV-2 Variants, Understanding the Range of Reactions to SARS-CoV-2, Lee, K. (2022, April 27). KaplanMeier survival analyses with log-rank test were performed to display the occurrence of negative PCR test results upon treatment. Shapira, T., Monreal, I. Get the most important science stories of the day, free in your inbox. Topol is also editor-in-chief of Medscape, WebMD's sister site for medical professionals. 48.9% (n=44) of the safety analysis set was male, and the average age was 35.6712.94years. 62, 50937, Cologne, Germany, You can also search for this author in . 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. 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. 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. 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. 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. The overall AUC of the Azelastine 0.1% group (red area) was significantly greater than that of placebo (green area), p=0.007. 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. Cornell research team to develop COVID-19 nose spray treatment. By Dr. Ramya Dwivedi, Ph.D. Jul 19 2021. New research has answers, COVID's future: mini-waves rather than seasonal surges, Are repeat COVID infections dangerous? 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. PubMed Central 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. volume13, Articlenumber:6839 (2023) It's a type of antibody that targets the coronavirus' spike protein. 16, 275282. A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic.