Figueroa of The Cesar Milstein Research Institute in Argentina and Dr. There were no differences in the incidence of adverse events between the two groups.
The incidence of COVID-19 infection was significantly lower in the Nasitrol group compared with placebo (1.0% vs 5.0%). The primary end point was clinical COVID-19 infection, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. Study subjects were randomly assigned to receive four daily doses of Nasitrol spray or placebo for 21 days. The current study was conducted at 8 hospital ICUs with a sample of 394 clinically healthy physicians, nurses and other medical professionals who provided care to COVID patients and who had not yet been vaccinated against the disease. A previous study at the University of Tennessee Health Science Center found that the iota carrageenan formulation inhibits infection by SARS-CoV-2, the virus that causes COVID-19, in cell culture in vitro. Nasitrol is a patented nasal spray based on iota carrageenan, a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as a nasal spray in the treatment of the common cold. through a licensing agreement from Laboratorio Pablo Cassara, an Argentinean pharma company leader in innovation.
Iota carrageenan nasal spray amazon trial#
2010 11:108.KIRKLAND, Wash.-( BUSINESS WIRE)-Amcyte Pharma, a Seattle-based company dedicated to the commercialization of immunomodulators, announced the results of an independent clinical trial among ICU staff suggesting that its product, Nasitrol TM nasal spray, represents a safe and effective treatment that could prevent transmission of COVID-19. Efficacy and safety of an antiviral Iota-Carrageenan nasal spray: a randomized, double-blind, placebo-controlled exploratory study in volunteers with early symptoms of the common cold. ×-5-107.Įccles R, Meier C, Jawad M, Weinmueller R, Grassauer A, Prieschl-Grassauer E. Iota-carrageenan is a potent inhibitor of rhinovirus infection. Grassauer A, Weinmuellner R, Meier C, Pretsch A, Prieschl-Grassauer E, Unger H. Iota-Carrageenan is a potent inhibitor of influenza A virus infection.
Leibbrandt A, König-Schuster M, Weinmüllner R, Kalthoff D, Pflugfelder B, Graf P, et al. The Economic Burden of Non–Influenza-Related Viral Respiratory Tract Infection in the United States. Viruses and bacteria in the etiology of the common cold. Mäkelä MJ, Puhakka T, Ruuskanen O, Leinonen M, Saikku P, Kimpimäki M, et al. Exploratory analyses indicated significant reduction of cold symptoms in the I-C group relative to placebo during the first four days when symptoms were most severe, and also substantiated I-C's activity against rhinovirus/enterovirus. The primary endpoint did not demonstrate a statistically significant difference between I-C and placebo but showed a trend towards I-C benefit. Treatments were well tolerated with no differences in adverse event rates. For patients with quantifiable rhinovirus/enterovirus at baseline, there was a trend towards greater reduction of virus load at Day 3 or 4 (p = 0.0958 I-C: 90.2 % reduction in viral load placebo: 72.0 %). Exploratory analyses after unblinding (TSS2-4 excluding a patient with aberrantly high symptom scores mean of TSS over Days 1-4 change in TSS1-4 relative to baseline ) demonstrated treatment differences in favor of I-C (p = 0.0364, p = 0.0495 and p = 0.0421, respectively). Viruses were detected in baseline samples from 53 of 98 I-C patients (54.1 %) and 54 of 97 placebo patients (55.7 %). Patients in both treatment groups had similar baseline TSSs (mean TSS: 6.75 for I-C and 6.79 for placebo). The primary endpoint was the mean total symptom score (TSS) of eight cold symptoms on Days 2-4 (TSS2-4). Common respiratory viruses were quantified by RT-PCR during pretreatment and on Day 3 or 4. Patients were to self-administer 0.12 % I-C or placebo spray (NaCl 0.5 %) four times daily for four to ten days and record symptom information for ten days. This randomized, placebo-controlled, double-blind phase IV trial was conducted in 200 adult patients with self-diagnosed colds of <48 h' duration that were confirmed by baseline cold symptom scores. The current trial served to further investigate I-C in patients with early common cold symptoms. Iota-carrageenan (I-C) is active against respiratory viruses in vitro and was effective as nasal spray in three previous clinical trials.
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