BOCA RATON - ioTech International announced today that three of its products, based on patented, proprietary, non-staining formulations of molecular iodine, are being used in an IRB approved, controlled clinical trial that was just initiated at St. Joseph's Hospital University Medical Center in Patterson, NJ. The products being evaluated are ioRinse Oral Rinse, ioCleanse Hand Cleanser and ioMist Nasal Spray. Each of these unique, high performance products utilize ioTech's patented molecular iodine technology. The trial is being led by Dr. Hillel Ephros, Chairman, Department of Dentistry/OMS. Program Director, Oral & Maxillofacial Surgery. Medical Director, The Regional Craniofacial Center. The endpoint of the six-week study will be a reduction in COVID-19 symptoms from healthcare workers who are using the ioTech products and are treating novel coronavirus patients compared to the control group.
"We are excited to start using ioTech's molecular iodine products in order to provide a critical extra layer of protection going beyond the CDCs recommended usage of PPE, soap & water and hand sanitizer. Using ioTech International's proprietary molecular iodine formulations enables St. Joseph Hospital to protect our medical staff by providing a highly effective antiviral that has displayed rapid and complete efficacy against Coronavirus (strain #229E) and other tenacious viruses in independent laboratory testing," said Dr. Ephros.
"ioTech International's proprietary formulations deliver up to 100 times more of the biocidal active, molecular iodine than povidone iodine alone, demonstrating profound antiviral activity across a wide range of difficult-to-kill pathogens," said Rodger Kolsky, Co-Founder and Director of R&D. Dr. Herb Moskowitz, ioTech International Inc's Co-founder and Chairman commented, "Reviewing the compelling results from multiple studies, we are confident that molecular iodine will play an important preventive and therapeutic role in helping to control the current COVID-19 pandemic."
Study Design
The clinical trial was designed to evaluate efficacy of ioTech International 's molecular iodine on skin and mucosa as an additional barrier to PPE for the transmission of COVID-19 to St. Joseph's Hospital employees engaged in patient care. The six week, two -arm randomized control study compares a control group of 300 employees following CDC guidelines versus 300 employees following CDC guidelines with adjunctive molecular iodine usage of oral rinse, nasal spray and hand sanitizer. A comparison of the control group versus active study group is the following:
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Arm 1 Control |
Arm 2 Active Study |
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Follow CDC guidelines at home and work. |
Follow CDC guidelines at home and work. |
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Take temperature twice daily at same time, ideally 12 hours apart. |
In addition, use molecular iodine hand sanitizer as directed 4 times daily whether at work or at home: on work days, use prior to work shift, during breaks and after the shift as well as after any suspected potential exposure due to PPE failure/inadequacy. |
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Complete the symptom checklist once daily for the entire duration of the study. |
In addition, gargle with provided oral rinse as directed 4 times daily whether at work or at home: on work days, gargle prior to each work shift, during breaks and after the shift as well as after any suspected potential exposure due to PPE failure/inadequacy. |
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If symptoms develop that suggest COVID-19 and/or a fever of over 100.4F is noted, COVID-19 testing should be done. |
In addition, use provided nasal spray as directed 4 times daily whether at work or at home: on work days, use nasal spray prior to each work shift, during breaks and after the shift as well as after any suspected potential exposure due to PPE failure/inadequacy. |
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Take temperature twice daily at same time, ideally 12 |
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Complete the symptom checklist once daily for the entire duration of the study. |
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If symptoms develop that suggest COVID-19 and/or a fever of over 100.4F is noted, COVID-19 testing should be done. |
Discontinuation
The investigator will terminate a participant, if the participant fails to report for three consecutive days of reporting; the participants can withdraw their participation without penalty or threat of future care. The Investigator will be notified of anyone's intention to discontinue.
ioTech International is a world leader in molecular iodine research and development. Its patented, breakthrough germicidal products are marketed under the brand names of ioRinse, ioCleanse, ioGel and ioMIST. ioRinse ready to use oral mouth rinse comes in 2 flavors and is recommended for twice daily use. ioCleanse hand cleanser spray is sprayed onto hands and then rubbed vigorously for 30-seconds until dry. ioMIST is a nasal spray inhaled through the nose. Each high-performance, unique product features ioTech's breakthrough, antimicrobial molecular iodine technology. ioTech International products can be found at iotechinternational.com.
