SARS-CoV-2 accelerated clearance using a novel nitric oxide nasal spray (NONS) treatment: A randomized trial
Monika Tandon, Wen Wu, Keith Moore, Stephen Winchester, Yuan-Po Tu, Christopher Miller, Rahul Kodgule, Amol Pendse, Shabbir Rangwala, Shashank Joshi
The Lancet Regional Health - Southeast Asia, doi:10.1016/j.lansea.2022.100036
Background Additional outpatient therapies which are readily accessible will be essential to reduce COVID-19 illness progression in high risk individuals. Especially as the virus continues to mutate with greater transmissibility despite increased global vaccination. Methods A randomized, double-blind, multicentre, parallel group, placebo-controlled phase III clinical trial evaluated the ability of nitric oxide (NO) to rapidly eradicate nasal SARS-CoV-2 RNA. Adults (18À70 years) with mild symptomatic COVID-19 were randomized, confirmed by laboratory SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) nasal swab. Randomisation was 1:1, NONS (N = 153) vs placebo (N = 153). NO generated by a nasal spray (NONS) was self-administered six times daily as two sprays per nostril (0Á45 mL of solution/dose) for seven days. Patients at high risk of illness progression, defined as unvaccinated, 45 years of age or having comorbidities, were the primary analysis population. Findings Overall, mean SARS-CoV-2 RNA concentrations (6¢96 log10 copies/mL in the NONS group and 7¢16 log10 copies/mL in the placebo group) were comparable at baseline. Primary endpoint mean treatment difference SARS-CoV-2 RNA change from baseline to the end of treatment (EOT) was -0¢52 copies/mL (SE 0¢202, 95% CI -0¢ 92 to -0¢12; p = 0¢010) with NONS compared to placebo. Secondary endpoint assessments demonstrated a greater proportion of patients receiving NONS (82¢8%) cleared SARS-CoV-2 (RT-PCR negative) by EOT compared to placebo (66¢7%, p = 0¢046), with no virus RNA detected a median of four days earlier compared to placebo (three vs seven days; p = 0¢044). Interpretation Use of NONS in patients recently infected with SARS-CoV-2 accelerates nasal virus clearance.
Supplementary materials Supplementary material associated with this article can be found in the online version at doi:10.1016/j.lan sea.2022.100036.
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