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All Studies   Meta Analysis   Recent:  
0 0.5 1 1.5 2+ Improvement, mITT-HR, d.. 42% Improvement Relative Risk Improvement, mITT-H.. (b) 67% Improvement, mITT-H.. (c) 68% Improvement, mITT, day 18 22% Improvement, mITT, day 16 18% Improvement, mITT, day 8 9% Viral load, mITT-HR 20% Viral load, mITT 14% Time to viral-, mITT-HR 26% Time to viral-, mITT 6% Nitric Oxide  Tandon et al.  EARLY TREATMENT  DB RCT Is early treatment with nitric oxide beneficial for COVID-19? Double-blind RCT 207 patients in India (August 2021 - January 2022) Improved viral clearance with nitric oxide (p<0.000001) Tandon et al., The Lancet Regional Hea.., Jun 2022 Favors nitric oxide Favors control

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

Tandon et al., The Lancet Regional Health - Southeast Asia, doi:10.1016/j.lansea.2022.100036, CTRI/2021/08
Jun 2022  
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RCT with 153 patients treated with a nitric oxide nasal spray, and 153 placebo patients, showing faster viral clearance with treatment. NO generated by a nasal spray (NONS) self-administered six times daily as two sprays per nostril (0.45mL of solution/dose) for seven days.
Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.
risk of no improvement, 41.9% lower, RR 0.58, p = 0.06, treatment 14 of 64 (21.9%), control 26 of 69 (37.7%), NNT 6.3, mITT high risk, day 18.
risk of no improvement, 66.8% lower, RR 0.33, p = 0.04, treatment 4 of 64 (6.2%), control 13 of 69 (18.8%), NNT 7.9, mITT high risk, day 16.
risk of no improvement, 67.7% lower, RR 0.32, p = 0.08, treatment 3 of 64 (4.7%), control 10 of 69 (14.5%), NNT 10, mITT high risk, day 8.
risk of no improvement, 22.3% lower, RR 0.78, p = 0.63, treatment 8 of 105 (7.6%), control 10 of 102 (9.8%), NNT 46, day 18, modified intention-to-treat.
risk of no improvement, 17.8% lower, RR 0.82, p = 0.67, treatment 11 of 105 (10.5%), control 13 of 102 (12.7%), NNT 44, day 16, modified intention-to-treat.
risk of no improvement, 8.9% lower, RR 0.91, p = 0.76, treatment 30 of 105 (28.6%), control 32 of 102 (31.4%), NNT 36, day 8, modified intention-to-treat.
viral load, 19.8% lower, relative load 0.80, p < 0.001, treatment mean 2.62 (±0.145) n=64, control mean 2.1 (±0.141) n=69, mITT high risk, day 8.
viral load, 13.5% lower, relative load 0.86, p < 0.001, treatment mean 2.51 (±0.114) n=105, control mean 2.17 (±0.118) n=102, day 8, modified intention-to-treat.
time to viral-, 26.1% lower, relative time 0.74, p = 0.09, treatment 64, control 69, inverted to make RR<1 favor treatment, mITT high risk, Kaplan–Meier.
time to viral-, 6.5% lower, relative time 0.94, p = 0.66, treatment 105, control 102, inverted to make RR<1 favor treatment, Kaplan–Meier, modified intention-to-treat.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Tandon et al., 29 Jun 2022, Double Blind Randomized Controlled Trial, placebo-controlled, India, peer-reviewed, 10 authors, study period 10 August, 2021 - 25 January, 2022, trial CTRI/2021/08.
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This PaperNitric OxideAll
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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