Povidone iodine (PVP-I) is a well-known broad spectrum, resistance free antimicrobial agent that has a long history of safe and effective use. Halodine Nasal Antiseptic is formulated for topical application PVP-I to nasal passages, and has demonstrated effectiveness against SARS-COV-2 in vitro - 99.99% inactivation within 15 seconds. This study will evaluate the ability of Halodine Nasal Antiseptic to impact SARS-CoV-2 in vivo.
This is a multicenter, phase 4 prospective, single-cohort study in adult male and female
volunteers hospitalized with COVID-19. Baseline nasopharyngeal swabs will be performed on all
individuals. Halodine Nasal Antiseptic will then be applied to the anterior nares. Serial
nasopharyngeal samples will then be collected at specified time points after the application.
All samples will be tested for SARS-CoV-2 by real-time reverse transcription (rRT)-PCR assay.
Drug: Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP
Single topical administration
Other Name: Halodine Nasal Antiseptic
Inclusion Criteria:
- Hospitalized with COVID-19
- Positive SARS-CoV-2 (rRT)-PCR within 48 hours of enrollment
Exclusion Criteria:
- Allergies to iodine-containing compounds
Samuel B Barone, MD
2023908590
sbarone@halodine.com
Samuel Barone, MD, Study Director
Halodine LLC