SALT LAKE CITY--(BUSINESS WIRE)--Xlear has supplemented the numerous scientific studies it has already provided the Department of Justice and the Federal Trade Commission (FTC) in the government’s lawsuit against Xlear. Specifically, Xlear provided additional studies showing that simple nasal sprays are effective in helping reduce the transmission of COVID-19 and reduce the severity of illness when used by individuals already infected with the virus. The DOJ-FTC have sued Xlear alleging prior statements about nasal hygiene and COVID-19 lacked adequate substantiation.
One of the studies Xlear provided to DOJ is a peer reviewed, published, double-blind, placebo controlled, randomized clinical trial (RCT), involving 556 “high-risk healthcare professionals”, finding that a nasal spray containing water, saline and xylitol significantly reduced the transmission of COVID-19 and the severity of cases among those infected. Specifically, the study finds: “[The spray] significantly reduced SARS-CoV-2 infection compared to placebo [36 cases (13.1%) Vs 97 cases (34.5%); OR 0.29 (95% CI; 0.18–0.45), p < 0.0001]. Fewer clinical symptoms were also seen in the test group [57 cases (17.6%) vs 112 cases (34.6%); OR 0.40, (95% CI; 0.27–0.59), p < 0.0001]. No harmful effects were associated with taking the [nasal spray] . . . This represents a 62% relative risk reduction in infection rate.” “[T]he spray was administered up to three times per day with . . . 6–8 [hour] between doses.” The Study concludes: “[The nasal spray] has been shown to significantly reduce SARS-CoV-2 infections in healthcare workers, with 62% fewer infections when compared to placebo.”
Full Study: Damian Balmforth, et al., Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial, Journal of Clinical Virology, 155 (2022), 105248, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9313533/.
(Xlear nasal spray similarly contains water, saline, and xylitol. Xlear does not include certain other ingredients used in the study spray, such as basil and clove oils. Instead, Xlear contains grapefruit seed extract, which other in vitro studies have shown deactivates the SARS-CoV-2 virus.)
It should be noted that the FDA approved the bivalent vaccines on the basis of data from 5 mice—with no human clinical data. See J. Smyth, C. Gilbert, US criticised for rolling out Covid boosters without human trials, Financial Times, Sept. 12, 2022, available at https://www.ft.com/content/92d52780-14c8-49a0-937b-a7722363254f.
“The healthcare professionals study is one in a series of studies finding the same. This one is just the most clearcut evidence,” Nate Jones, Xlear’s CEO noted. “With the COVID-19 pandemic in its third year, it’s ludicrous that the FTC is seeking to censor this vital science,” he added.
Xlear’s supplemental data filing also included:
Chien-Ting Wu, et al. SARS-CoV-2 replication in airway epithelia requires motile cilia and microvillar reprogramming, Cell, 186 (2023), 112-130, available at https://www.cell.com/cell/fulltext/S0092-8674(22)01505-7 - secsectitle0020. A Stanford University news story quoting one of the researchers notes: “’[S]ubstances used in these experiments could perhaps be optimized for use in, say, nasal sprays soon after a respiratory viral exposure, or as prophylactics. Delaying viral entry, exit or spread with a locally applied, short-duration drug would help our immune systems catch up and arrive in time to stop full-blown infection and hopefully limit future pandemics.’” The researchers discuss the possibility of a “morning after” COVID nasal spray.
Riccardo Nocino, et al., Improving Nasal Protection for Preventing SARS-CoV-2 Infection, BioMedicines, 10 (2022), 2966. Expert analysis that: “Among various infection preventive strategies, those based on generating physical barriers within the nose, aimed at impeding host cell penetration (i.e., using compounds with mucoadhesive properties, which act by hindering, entrapping or adsorbing the virus), or those preventing the association of SARS-CoV-2 with its cellular receptors (i.e., admin- istering anti-SARS-CoV-2 neutralizing antibodies or agents that inhibit priming or binding of the spike protein) could be considered appealing perspectives. Provided that these agents are proven safe, comfortable, and compatible with daily life, we suggest prioritizing their usage in subjects at enhanced risk of contagion, during high-risk activities, as well as in patients more likely to develop severe forms of SARS-CoV-2 infection.”
This product is not intended to diagnose, treat, cure, or prevent any disease.
