NONS
Trial question
What is the role of novel nitric oxide nasal spray in patients with recent COVID-19 infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 306
306 patients (109 female, 197 male).
Inclusion criteria: adult patients with mild symptomatic COVID-19.
Key exclusion criteria: requirement of oxygen support and hospitalization; pneumonia; pregnancy; allergy to nitric oxide nasal spray; asthma.
Interventions
N=153 nitric oxide nasal spray (self-administered 6 times a day as 2 sprays per nostril for 7 days).
N=153 placebo (matching placebo nasal spray for 7 days).
Primary outcome
Reduction in viral ribonucleic acid load at day 8
2.62
2.1
2.6 log10...
2.0 log10...
1.3 log10...
0.7 log10...
0.0 log10...
Nitric oxide nasal
spray
Placebo
Significant
increase ▲
Significantly greater reduction in viral RNA load at day 8 (2.62 log10 copies/mL vs. 2.1 log10 copies/mL; AD 0.52 log10 copies/mL, 95% CI 0.12 to 0.92).
Secondary outcomes
Significant increase in patients with negative conversion of RT-PCR at day 8 (82.8% vs. 66.7%; AD 16.1%, 95% CI 0.2 to 32.1).
Significantly shorter time to negative conversion of RT-PCR (3 days vs. 7 days; AD -4 days, 95% CI -7.9 to -0.1).
No significant difference in patients with ≥ 2% improvement in the WHO Clinical Progression Scale score at day 8 (78.1% vs. 62.3%; AD 15.8%, 95% CI -1 to 32.6).
Safety outcomes
No significant differences in methemoglobin levels, nasal vasodilation symptoms, systemic vasodilation signs.
Conclusion
In adult patients with mild symptomatic COVID-19, nitric oxide nasal spray was superior to placebo with respect to reduction in viral RNA load at day 8.
Reference
Monika Tandon, Wen Wu, Keith Moore et al. SARS-CoV-2 accelerated clearance using a novel nitric oxide nasal spray (NONS) treatment: A randomised trial. Lancet Reg Health Southeast Asia. 2022 Jun 29;3:100036.
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