Dataset Information

SARS-CoV-2 accelerated clearance using a novel nitric oxide nasal spray (NONS) treatment: A randomised trial.

ABSTRACT:

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 (18-70 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 (0.45 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.

Funding

Funding provided by Glenmark Pharmaceuticals Limited. Study medication provided by SaNOtize.

SUBMITTER: Tandon M

PROVIDER: S-EPMC9239922 | biostudies-literature |

REPOSITORIES: biostudies-literature

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