Phase 3 Clinical Trial Confirms SaNOtize’s Treatment is 99% Effective Against COVID-19

SaNOtize and Glenmark Pharmaceuticals Limited has announced on February 09, 2022:
  • Phase 3 trial reached primary endpoint and demonstrated a reduction in SARS-CoV-2 log viral load in COVID-19 patients by more than 94% within 24 hours of treatment, and by more than 99% in 48 hours
  • Treatment also demonstrated, in the high-risk group (n=218), a greater proportion of patients who achieved a combination of clinical and virological cure, based on the WHO Progression Scale
  • Median time to virological cure was 4 days in the treatment group, 8 days in the placebo group (p < 0.05).

A Phase 3 clinical trial was conducted in adult COVID-19 patients across 20 clinical sites in India.

The double-blind, parallel arm, multicenter study, conducted in 306 patients evaluated the efficacy and safety of Nitric Oxide Nasal Spray versus normal saline nasal spray in non-hospitalized adult patients.

All patients received standard supportive care in the study.

The trial analyzed patients with risk of progression of disease - non-vaccinated patients, patients in the middle and older age group and patients with co-morbidities.

Primary endpoint was met: Reduction in log viral load in the NONS group was statistically significant and superior to the control (placebo) group (p < 0.05).

The median time to virological cure was 4 days in the NONS group and 8 days in the placebo group (p < 0.05).

A significantly higher proportion of patients demonstrated a 2-point improvement on the WHO Progression Scale (a validated clinical endpoint) in the NONS group as compared to the placebo group (p < 0.05).

NONS was safe and well tolerated by patients. No patients experienced moderate, severe, serious Adverse Events (AE) or death in the study.

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