Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection
Summary
Cellular Sciences Inc has submitted over 17 human clinicals (phase I, II, III including animal safety data) to the FDA for the reduction of respiratory inflammation and inflammatory cytokines including IL-6 the cause of the cytokine storm in COVID patients. These clinicals demonstrated a reduction of inflammation in all lung and sinus diseases, in patients with COPD, Pulmonary fibrosis, CF, asthma, sinusitis , the flu and nasal inflammation and congestion. Inhaled sodium pyruvate reduces inflammation, congestion and in our phase III clinical study with Idiopathic Pulmonary Fibrosis patients we demonstrated statistically and clinical significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (form 52% to 86%) and a decrease in hypoxemia, and a reduction in coughing. Inhaled sodium pyruvate alleviated the symptoms associated with COVID-19 patients in Pulmonary Fibrosis, and may be a solution to the lingering COVID-19 symptoms in patients that had the COVID-19 infection for example long haulers. In flu and COVID infected mice, nebulized sodium pyruvate decreased morbidity, weight loss, inflammatory cytokines and decreased viral titers compared to placebo controls. The study to be done at Missouri State University is titled ( Two week sub-chronic double-blinded placebo controlled trial designed to determine if sodium pyruvate nasal spray will reduce the symptoms, duration and replication of COVID-19 infection)
Timeline
- Start
- 2021-04-12
- Primary completion
- 2022-08-12
- Completion
- 2022-08-12
Outcome
Mixed primary results
registry p = 0.0197; Mean Difference (Final Values) -0.3379 (95% CI -0.6213 to -0.0545); ANOVA NCT04824365 ↗
registry p = 0.736; Mean Difference (Final Values) 0.0381 (95% CI -0.1843 to 0.2605); ANOVA NCT04824365 ↗
Publications
- Background Reel JM, Lupfer CR. Sodium Pyruvate Ameliorates Influenza A Virus Infection In Vivo. Microbiology Research. 2021; 12: 258-267.
- Background Abusalamah H, Reel JM, Lupfer CR. Pyruvate affects inflammatory responses of macrophages during influenza A virus infection. Virus Res. 2020 Sep;286:198088. doi: 10.1016/j.virusres.2020.198088. Epub 2020 Jul 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Pyruvate | Unknown | — | Intranasal |