The study was termed CARVIN (referring to COVID-19: Azelastine nasal spray Reduces Virus-load In Nasal swabs). Marinomed plans a clinical trial with Carragelose nasal spray as COVID Killingley, B. et al. Smell retraining therapy (SRT) is a treatment for loss of smell, also referred to as hyposmia or anosmia. 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. PubMed 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). What scientists say. Boots Dual Defence Nasal Spray is used to dampen the symptoms of cold and flu. 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. 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. 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). https://doi.org/10.1007/s11224-020-01605-w (2020). The current study was a randomized, parallel, double-blind, placebo-controlled trial. Thank you for visiting nature.com. Moreover, this group showed that azelastine has the potential to inhibit SARS-CoV-2 cell entry by binding to the angiotensin-converting enzyme 2 (ACE2) receptor and to inhibit intracellular virus replication through binding to the sigma-1 receptor6. Gottlieb, R. L. et al. Overall, no statistical differences between groups were determined. A TMPRSS2 inhibitor acts as a pan-SARS-CoV-2 prophylactic and therapeutic. Google Scholar. the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Small differences were found with regard to age and bmi, which were both slightly higher in the azelastine 0.1% group (supplementary Table S1). Trials underway to see if Boots cold remedy can tackle coronavirus Zapor, M. Persistent detection and infectious potential of SARS-CoV-2 virus in clinical specimens from COVID-19 patients. Whereas PCR data of individual days served for daily comparisons between treatment groups, the area under the curve (AUC) value was used for the evaluation of the overall development of viral kinetics. . Povidone iodine mouthwash, gargle, and nasal spray to reduce nasopharyngeal viral load in patients with COVID-19: A randomized clinical trial. Multinomial regression analysis was done to 26 determine the association between nasal carriage of Bacillus and COVID-19 severity after 27 adjusting for age, sex, and co-morbidity status. 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. 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. Winchester, S., John, S., Jabbar, K. & John, I. 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. This is similar to the natural SARS-CoV-2 clearance time of approximately 2weeks. Decreases of viral load were also reflected in increases of negative PCR results over time. Trial registration: The study was registered in the German Clinical Trial Register (DRKS-ID: DRKS00024520; Date of Registration in DRKS: 12/02/2021). AB is employed at Ursatec GmbH, supplier of primary packing materials to Ursapharm. Studies into Xlear's antiviral effects on SARS . In a study examining the effect of azelastine nasal spray on upper respiratory infections in children, it was found that the placebo group, receiving hypertonic saline solution (twice daily) also produced a favourable response compared to those receiving no treatment31. Researchers at Swansea University will begin human trials this week following a successful study suggests the 5.99 remedy, Dual Defence, could help reduce infections thanks to its special ingredient - seaweed . Resource-efficient internally controlled in-house real-time PCR detection of SARS-CoV-2. Antiviral efficacy was observed at an EC50 of~6M, which is an approximately 400-fold lower concentration compared to commercially available azelastine nasal sprays. Overall, no significant differences were observed between treatment groups regarding gender, age and body mass index (bmi, supplementary Table S1). https://doi.org/10.1021/acsmedchemlett.0c00521 (2020). 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. The independent 25 variable was the nasal carriage of Bacillus species. 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). were involved in data management. 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. Ther. . performed and supervised sample processing and viral load measurements. 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. 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. Performance of self-collected saliva testing compared with nasopharyngeal swab testing for the detection of SARS-CoV-2. Although no significant differences between groups regarding the total symptom score was shown, it may be speculated that the 0.1% azelastine spray may have positive influences on single symptoms such as shortness of breath, which was improved significantly greater in this treatment group compared to placebo at early time points of infection. 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. 42, 17. Upon treatment, a gradual decline of viral load from baseline (day 1) to day 11 of treatment was observed in all three study groups. PDF Effect of nasal carriage of Bacillus species on COVID-19 severity: A PubMed Now, researchers at Swansea University will test it against Covid-19. Early intervention with azelastine nasal sprays reduces viral load in SARS-CoV-2 infected patients. . BR, SMS, HS, CA, NW, SA, and RM are employees of ClinCompetence Cologne, the CRO which organized this trial. https://doi.org/10.1038/s41401-020-00556-6 (2020). The mean bmi of participants was 24.915.27. 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. Patients of the current trial were eligible upon positive PCR test results, and if enrolled no later than 48h after swab sampling. Article Anti. PM, MF, DG, CS and BS are employed at URSAPHARM Arzneimittel GmbH. Other evidence of viral infection showed similar differences between treated and untreated mice in the protective lining of cells called theepithelium inside the nose, nasal mucosa, and airways.. reviewed, edited and finalised the manuscript. ACS Med. KaplanMeier analysis results regarding the ORF 1a/b gene from baseline (day 1) until day 11 of treatment (ITT analysis set). 19(10), 16. 1). Overall, data of the primary outcome did not show a normal distribution (ShapiroWilk test, p<0.05). 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. was responsible for data management activities. Science 371, 13791382 (2021). Postdoctoral fellowship in vascular biology at UT Southwestern, studying the endothelial basis of cardiometabolic disease. 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. Correspondence to You are using a browser version with limited support for CSS. Use the Previous and Next buttons to navigate the slides or the slide controller buttons at the end to navigate through each slide. 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. 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. and F.H. The reduction in the symptom score was clinically relevant for all three groups. Google Scholar. During the throes of the COVID-19 pandemic, Anne Moscona didnt feel safe going to a restaurant or catching a flight. Mice treated with just a single dose of N-0385 on the day they were infected had a high survival rate as well. If delivery took place within 24h after sampling, samples were to be stored at<25C, if storage period was greater than 24h (e.g., on Sundays), samples had to be stored and shipped at 28C. Within the subgroup of patients with baseline Ct values below 25, a similar progression of viral load data was observed (Fig. & Ware, J. This way, the virus moves on.. By submitting a comment you agree to abide by our Terms and Community Guidelines. Patient reported outcomes were documented by patient diaries and questionnaires. https://doi.org/10.1001/jamaoto.2020.5490 (2021). D.G., C.S. 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. Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults. Area under the curve (AUC) reflecting changes in viral copy numbers (log10 cp/mL) from baseline (day 1) over time (until day 11) based on the ORF 1a/b gene (ITT analysis set). https://doi.org/10.1056/NEJMc2027040 (2021). CAS Liu, L. et al. Patients had to daily document their COVID-19 specific symptoms in an electronic patient diary. The anti-histamine azelastine, identified by computational drug repurposing, inhibits infection by major variants of SARS-CoV-2 in cell cultures and reconstituted human nasal tissue. Elife 10, e69302. 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 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). Suitable for 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. Study endpoints were presented by descriptive statistics, aiming to compare the course of viral load between the three treatment groups. identified azelastine as an anti-viral candidate and demonstrated pronounced anti-SARS-CoV-2 activity in vitro10. The aim of our study was to support the preclinical evidence for azelastines antiviral activity in patients tested positive for SARS-CoV-2.
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