Phase II Trial of the Impact 0.5% Povidone-Iodine Nasal Spray (Nasodine®) on Shedding of SARS-CoV-2.

ABSTRACT

OBJECTIVE: A Phase II trial was conducted to determine if nasal disinfection with a commercial Good Manufacturing Practice-manufactured 0.5% povidone-iodine nasal spray (Nasodine®) may be a useful adjunct in the management of COVID-19 by reducing viral shedding and prevention of transmission of SARS-CoV-2. The aim was to confirm the results from a human single-dose pilot study by assessing repeated and frequent doses on nasal shedding of SARS-CoV-2 from adult subjects with confirmed COVID-19. METHODS: A multicenter, randomized, double-blinded, placebo-controlled Phase II clinical trial involving adults with early COVID-19 symptoms. Baseline nasal swabs were collected to quantify pretreatment SARS-CoV-2 nasal viral load, followed by Nasodine treatment eight times daily over 3 calendar days. Daily nasal swabs were collected post-dose to assess the impact of treatment on nasal viral load, measured by log10 TCID50 in quantitative culture. RESULTS: Nasodine subjects exhibited significantly improved reduction in viral load (log10 TCID50) on Days 2-4 compared to placebo recipients (p = 0.028), rate of nasal clearance of viable virus (p = 0.032), and complete (100%) nasal and throat clearance of the virus by Day 5. No difference was seen in antigen shedding as measured by time transition from Rapid Antigen Test (RAT) positivity to RAT negativity. CONCLUSION: A total of 20 doses of Nasodine® nasal spray administered over 2.5 days significantly reduced the titers of viable SARS-CoV-2 virus in the nasal passages of COVID-19 subjects. This is the first study demonstrating the efficacy of a tolerable intranasal formulation of povidone-iodine on viral shedding in COVID-19 subjects. Nasal disinfection may diminish viral transmission to others. LEVEL OF EVIDENCE 2 Laryngoscope, 1343947-3952, 2024.