BioSimplx LLC is providing recent information concerning the use of Iodine based Nasal and Oral Spray Rinse products in clinical trials regarding COVID-19.
These studies are addressing whether, and to what extent, each of these products may function to inactivate the coronavirus. As the medical and scientific literature continues to evolve to establish a consensus, we are monitoring these developments to better understand the efficacy of Iodine nasal and oral spray rinses to inactivate SARs-COV2. While current available data is insufficient to support a conclusion that the use of these products is helpful in the prevention and treatment of COVID-19, research is underway to provide greater insight.
Due to global interest in this area we are presenting the following information on emerging science and medical research.
AQUARA™ is a physician formulated Iodine-based Nasal spray & Oral spray rinse personal care product that keeps the oral and nasal passageways hygienically cleansed. AQUARA™ is not intended to prevent or treat COVID-19 and should be used only as directed on the product label.
Several independent clinical trials have been completed while others are currently underway to assess Iodine based nasal and oral spray rinses ability to deactivate enveloped viruses, including the coronavirus. The current available data is insufficient to support a clinical conclusion with regards to the antiviral efficacy in connection with SARs-COV2. BioSimplx LLC is a personal care company rooted in science and committed to advancing the public health.
The scientific and medical community’s understanding on the course of COVID-19 disease treatment and transmission continues to evolve, and more research is needed to understand how and whether the use of Iodine based nasal and oral spray rinses might impact viral entry, load, exposure and transmission that ultimately affect meaningful clinical outcomes or produce a positive public health impact. We continue to follow the clinical studies and regulatory developments to highlight the best medical and scientific information concerning Iodine-based nasal and oral spray rinses and the coronavirus.
IN VIVO STUDIES
One small clinical trial has been completed (n=20; 5 per treatment arm) and results were posted in June 2020 clinicaltrials.gov a manuscript is available on a pre-print server.
One group of participants was instructed to gargle three times per day for 30 seconds with a Povidone Iodine rinse. RT-PCR Testing of the participants was to be performed on day 4 and day 6.
SUMMARY:The authors observed that the group who gargled with Povidone-Iodine three times per day all had negative RT-PCR tests by day 6 while zero participants from the control group had recorded a negative RT-PCR test by day 6.
This study is entitled Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients (GARGLES) has not yet been published in a peer-reviewed journal and cannot be used to draw conclusions.
The objective of this study was to determine if povidone iodine could reduce viral load and if so which application (nasal spray, nasal irrigation, oral spray) and in what concentration would achieve the best results.
SUMMARY: The authors observed that “a statistically significant proportion of nasopharyngeal clearance with all strengths of PVP-I NI and PVP-I NS (compared to the corresponding controls) was observed, so our recommendation is to use PVP-I prophylactically in nasopharynx as well as oropharynx (through which areas SARS-CoV2 enters and resides for a while) for prevention of COVID-19”.
This study is entitled Virucidal Effect of Povidone Oodine on COVID-19 in the Nasopharynx: An Open-label Randomized clinical trial but has not yet been published in a peer-reviewed journal and cannot be used to draw conclusions.
IN VITRO DATA
We are aware of the following external, independent lab studies;
There are a number of additional independent studies (below) that have evaluated the antiviral activity of various IODINE based nasal and oral spray rinses against coronaviruses and to better understand whether nasal and or oral spray rinses have the potential to reduce the viral load in the oral cavity and oropharynx, and/or reduce the transmission of the virus.
ADDITIONAL RESEARCH IN PROGRESS
Malaysia study links to results on ClinicalTrials.gov and online publication:
University of Witten/Herdecke, Faculty of Health study link: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023725
Augusta University (Georgia) study link: https://clinicaltrials.gov/ct2/show/NCT04719208?term=mouthwash&cond=Covid19&draw=2&rank=5
Milton S. Hershey Medical Center (Penn State) https://clinicaltrials.gov/ct2/show/NCT04802408?term=mouthwash&cond=Covid19&draw=2&rank=16
BIOSIMPLX LLC RESPONSE
As a company firmly rooted in promoting the public health, we will continue to monitor the science, engage in the scientific exchange and ongoing research relating to this topic.
As of December 6, 2021