COVID-19 Treatment IND Filed With FDA
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COVID-19 Treatment IND Filed With FDA

COVID-19 Treatment IND Filed With FDA

Miami, Florida – Dr. Gustavo Ferrer MD, in partnership with Larkin Community Hospital of Miami, FL, and XLEAR, the leading manufacturer of natural, proactive health care products with xylitol today formally filed an IND (Investigational New Drug) application with the FDA. The study, which will take place at Larkin Community Hospital in Miami, Florida will be led by Principal Investigator Dr. Gustavo Ferrer, MD, who in addition to running two Florida ICUs during the COVID-19 pandemic has also been highly sought after subject matter expert for both domestic and international media outlets. The study will be a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy of Xylitol and GSE nasal spray (XLEAR) in improving symptoms and reducing time to negative nasopharyngeal swab in adult patients with COVID-19.

In a recent landmark study published in Cells, a researcher from the University of North Carolina at Chapel Hill found a gradient with greater expression of ACE2 receptors and SARS-CoV-2 infectivity in the nose compared to the peripheral lung tissue. This study supports XLEAR’s previous argument that therapeutic strategies should aim at reducing viral load in the nose early in the disease using nasal sprays or lavages.

In unpublished studies conducted at Utah State University Virology Institute, testing of each component of XLEAR individually found that GSE exerted a significant virucidal effect. Subsequently, at Geneva University testing was performed on the final, commercially available product and found a powerful virucidal effect that was not present with saline and xylitol alone.

Given the strong virucidal evidence supporting a nasal spray compound of xylitol and GSE on treating COVID-19, Ferrer is proposing a randomized study to measure the time to the negativity of a positive nasopharyngeal swab polymerase chain reaction (PCR) test. This would lead to a follow-up study to determine the impact of XLEAR in the reduction of the viral load and a clinical trial on the prevention of exposure in high-risk healthcare professionals.

If this study proves what the preliminary science shows, this will be the simplest, most cost-effective solution yet proposed or studied as it would be less than $5 a month per person.

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