It is important to note that in vivo (human/animal) studies have not been conducted to evaluate the effectiveness of Betadine® antiseptics in the prevention or treatment of SARS-CoV-2 infection, nor have any human clinical studies been conducted to assess its safety or effectiveness as a virucidal agent.
Betadine® Antiseptic Oral Rinse (Povidone Iodine 0.5%) is used by healthcare professionals for pre-procedural preparation of the oral mucosa. This product should not be ingested. Use Betadine products only as directed on the label.
STAMFORD, Conn. – April 13, 2022 – Avrio Health L.P. and University of Pennsylvania have announced today that the University of Pennsylvania School of Dental Medicine Center for Clinical and Translational Research has been awarded an investigator-initiated research (IIR) grant from Avrio Health to investigate whether a povidone-iodine antiseptic oral rinse reduces the amount of SARS-CoV-2, the virus that causes COVID-19, in the mouth. The study includes Avrio’s Betadine® Antiseptic Oral Rinse, povidone-iodine 0.5% solution.
The study is currently enrolling eligible participants in a randomized, double-blind, parallel group, controlled clinical trial to evaluate the effect of povidone-iodine antiseptic oral rinse compared to a placebo oral rinse on reducing SARS-CoV-2 load in the mouth in COVID-19 positive individuals. The study plan is to enroll forty participants 18 years of age and older who are within five days of a positive COVID-19 test and have at least one clinical sign or symptom of COVID-19. During Phase 1, participants will attend one study visit where they will be asked to rinse/gargle with the assigned oral rinse and provide saliva and mouth swab samples. Interested participants will be invited to continue to Phase 2, during which participants will be given the povidone-iodine antiseptic oral rinse and asked to use it at home for one week followed by a final remote visit at the end of the week. Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT05239598.
“We are pleased to be continuing our commitment to supporting research into potential virucidal properties of Betadine against the SARS-CoV-2 virus,” said Julie Ducharme, BPharm, MSc, PhD, vice president and chief scientific officer, Purdue Pharma. “We look forward to learning more from this research program as the medical community continues to pursue scientific discovery to help address public health needs.”
This investigator-initiated research is being independently developed and implemented by Investigators at the University of Pennsylvania School of Dental Medicine via a research grant and Betadine oral antiseptic product provided by Avrio Health.
Betadine® Topical Antiseptic products have been used in the hospital and outpatient setting for their antimicrobial properties for more than 50 years. Betadine® Topical Antiseptic products currently available in the U.S. are for external use only and should not be gargled or swallowed. Use only as directed on the label. Betadine® Antiseptic Sore Throat Gargle (povidone iodine 0.5%), which should not be ingested, is used for the temporary relief of sore throat. Betadine® Antiseptic Oral Rinse (povidone iodine 0.5%) is used by healthcare professionals for pre-procedural preparation of the oral mucosa.
About Avrio Health L.P.
Avrio Health L.P., a subsidiary of Purdue Pharma, is a consumer health products company that champions an improved quality of life for people in the United States through the reimagining of innovative product solutions. We have a strong portfolio of well-respected and proven effective brands, including Betadine®, Colace®, Senokot®, and SlowMag® Mg.
Penn Dental Medicine Center for Clinical and Translational Research
Penn Dental Medicine has a rich history as a research intensive institution and continues to be an international leader in the generation of new knowledge and treatment modalities to improve oral health. The Center for Clinical and Translational Research at Penn Dental Medicine advances human subjects research across disciplines to develop the clinical evidence needed to apply new technologies and treatments to patient care. The Center supports Penn Dental Medicine faculty across the full spectrum of clinical research from study conceptualization to closeout.