This same site is shared among many variants of the COVID virus, so it could be effective against future variants as well, researchers note. A complete list of inclusion and exclusion criteria is presented in Table 1. Absolute changes of total symptom scores from baseline (day 1) until day 11 of treatment (ITT analysis set). 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). were involved in data management. Patients were visited and tested at home on regular basis by the investigators, physicians specialised in otorhinolaryngology, medical hygiene, or general medicine. All methods were carried out in accordance with relevant guidelines, and the principles of Good Clinical Practice and the Declaration of Helsinki were adhered to. Symptoms were documented in patient diaries. Antiviral efficacy was observed at an EC50 of~6M, which is an approximately 400-fold lower concentration compared to commercially available azelastine nasal sprays. Article Mitze, T. & Rode, J. Early-stage spatial disease surveillance of novel SARS-CoV-2 variants of concern in Germany with crowdsourced data. It would be desirable to use a validated, COVID-19 specific questionnaire in future studies, and first attempts for its development are promising32. Objective of the study is to assess the efficacy of Carragelose nasal and throat spray in reducing the rate, severity, and duration of COVID-19 infections. However, the overall small number of participants limits conclusions, and results should be interpreted with care. Rep. 117 https://doi.org/10.1007/s43440-023-00463-7. Treatment kits were manufactured by URSAPHARM Arzneimittel GmbH, Saarbruecken, Germany, according to the randomization list (as sequentially numbered containers). 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.. The independent 25 variable was the nasal carriage of Bacillus species. Recently, Shmuel et al. The product targets a stable site on the spike protein of the virus that is not known to mutate. 20, e192e197. The experimental drug works in mice, and researchers believe it may be effective in humans. & Ware, J. 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). The reduction in the symptom score was clinically relevant for all three groups. Nature 581, 465469. Patients of the current trial were eligible upon positive PCR test results, and if enrolled no later than 48h after swab sampling. 11, 25262533. Identification of 14 known drugs as inhibitors of the main protease of SARS-CoV-2. Initial report of decreased SARS-CoV-2 viral load after inoculation with the BNT162b2 vaccine. 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. Health-related quality of life in patients with COVID-19; international development of a patient-reported outcome measure. Chem. 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. Kalle Saksela, MD, PhD, virologist, University of Helsinki, Nature Communications: Intranasal trimeric sherpabody inhibits SARS-CoV-2 including recent immunoevasive Omicron subvariants.. JAMA 325, 632644. 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. 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. Infect. Chavda, V. P., Baviskar, K. P., Vaghela, D. A., Raut, S. S. & Bedse, A. P. (2023) Nasal sprays for treating COVID-19: A scientific note. 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). Killingley, B. et al. The primary endpoint of the CARVIN study was the assessment of virus load kinetics of SARS-CoV-2 by determining the presence and amount of viral carriage via PCR. Further endpoints include infection. 8, e70. The current study was a randomized, parallel, double-blind, placebo-controlled trial. KaplanMeier survival analyses with log-rank test were performed to display the occurrence of negative PCR test results upon treatment. Anti. Reznikov et al. PubMed 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. Researchers have looked for ways to prevent SARS-CoV-2 infection that the virus cant learn to dodge or evade by mutating. Scientific Reports (Sci Rep) Identification of SARS-CoV-2 entry inhibitors among already approved drugs. and JavaScript. Rev. Small differences were found with regard to age and bmi, which were both slightly higher in the azelastine 0.1% group (supplementary Table S1). For male patients, the assessment was done via phone call. More information about the results of the study, which was funded in part by NIAID. 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. and F.H. 03:08. When the treatment course was shortened to four days, starting one day before infection, all 10 of the mice treated with N-0385 survived. 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. 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. PubMed PubMed Central Infect. Shapira, T. et al. 18, 110. https://doi.org/10.1186/s12985-021-01559-3 (2021). Smell Retraining Therapy. Patient Rep. Outcomes 6, 26. https://doi.org/10.1186/s41687-022-00434-1 (2022). 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. Google Scholar. identified azelastine as an anti-viral candidate and demonstrated pronounced anti-SARS-CoV-2 activity in vitro10. Konrat, R. et al. 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. 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. https://cornellsun.com/2022/04/27/cornell-research-team-to-develop-covid-19-nose-spray-treatment/, https://doi.org/10.1038/s41586-022-04661-w, Antiviral Nasal Spray Shows Promise Fighting COVID-19. MG, PA, HM and HAS declare no conflict of interest. A pilot study of 0.4% povidone-iodine nasal spray to eradicate SARS-CoV-2 in the nasopharynx. 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 PM, MF, DG, CS and BS are employed at URSAPHARM Arzneimittel GmbH. ISSN 1476-4687 (online) Correspondence to A phase 1 study for IGM-6268 is still taking place, and it's expected to be finished by December 2022. performed the statistical analysis. 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. Quantifying the relationship between SARS-CoV-2 viral load and infectiousness. Future studies will help understanding the impact of azelastine hydrochloride in treating SARS-CoV-2 infected patients. 24 COVID-19 status classified as negative, asymptomatic, mild, or severe. 5) Of note, these differences were not statistically significant (p=0.112). 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). Trial registration: The study was registered in the German Clinical Trial Register (DRKS-ID: DRKS00024520; Date of Registration in DRKS: 12/02/2021). Front. https://doi.org/10.1080/14787210.2021.1908127 (2021). https://doi.org/10.21203/rs.3.rs-864566/v1. Acta Pharmacol. also provided experimental evidence for the inhibition of the enzyme in a kinetic activity assay7. ISSN 0028-0836 (print). The Sponsor designed a dual chamber nasal spray bottle for NORS administration. SARS-CoV-2 viral load predicts COVID-19 mortality. As expected, a continuous decrease in the mean virus load was observed in all study groups during the 11 treatment days. D.G., C.S. Provided by the Springer Nature SharedIt content-sharing initiative. 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 viral load reduction of the ORF 1a/b gene from baseline to day 11 was log10 5.042.05 in the 0.1% azelastine group, log10 4.391.74 in the 0.02% azelastine and log10 4.151.34 in the placebo group. 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? J. 42, 17. Comparably, differences in reduction of log10 viral load (cp/mL) in our study were0.63 (ORF 1a/b gene) comparing treatment with 0.1% azelastine to placebo. https://doi.org/10.1007/s11739-021-02786-w (2021). SARS-CoV-2 infection progression starts with viral entrance mediated by the spike glycoproteins interaction with the host ACE2 receptor molecule. 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. Three-group comparisons were analysed with KruskalWallis test. For clarity reason, only cp/mL values of the ORF 1a/b gene are shown in the main text of the manuscript. But vaccines are fighting a changing opponent. were investigators involved in the conduct of the study. 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. The reduction in virus load over the entire treatment period was clinically meaningful for all three groups (p<0.0001 for both genes). reviewed, edited and finalised the manuscript. 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%. . Expert. Early negativization of SARS-CoV-2 infection by nasal spray of seawater plus additives: The RENAISSANCE open-label controlled clinical trial. Antiviral activity was subsequently verified in cell culture. Now, researchers at Swansea University will test it against Covid-19 Now, researchers at Swansea University. 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.. Since viral levels during early infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) tend to be highest in the nose and nasopharynx 1, a nasal spray with an active substance . Nasopharyngeal swabs were obtained by investigators using nylon-flocked swabs (Biocomma; SW01E, flexible minitip, Biocomma, Shenzen, China). Med. Internet Explorer). Samples of day 1 represent pre-treatment baseline samples. 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. These nanobodies and TriSb92 target a specific part of the coronavirus spike protein called the receptor-binding domain (RBD). Nat. https://doi.org/10.1038/s41401-020-00556-6 (2020). From hydroxychloroquine and veterinarian doses of the antiparasitic drug ivermectin, questionableand potentially harmfultreatments for COVID-19 have circulated the internet. The researchers picked four compounds that worked at very low concentrations and did not negatively affect the host cells. Z. Gesundheitswissenschaften J. Currently, the jury is out on their effectiveness and evidence is still limited, but it's possible they could act as a prophylactic for a short period of time. The team will enrol 480 healthworkers, including nurses and doctors . Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Absolute changes in viral copy numbers (log10 cp/mL) from baseline (day 1) over time based on the ORF 1a/b gene (ITT analysis set). FH is the CEO of URSAPHARM Arzneimittel GmbH. A research study at Swansea University is examining the efficacy of Boots Dual Defence - a 5.99 nasal spray containing seaweed - in preventing people becoming ill with Covid and reducing the .