Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

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)
    

Detailed description: 
      Inhibition of Viral Replication, Reduction of the "Cytokine Storm" and reduction of COVID-19
      symptoms- Potential Treatment and Preventative for COVID-19

      In numerous human clinical trials (17, phase I, II, III clinical trials) submitted to the
      FDA, with Pulmonary Fibrosis, COPD and Cystic Fibrosis patients, inhaled sodium pyruvate
      reduced nasal and lung inflammation and congestion by reducing inflammatory cytokines
      including the IL-6 cytokine that causes the so-called cytokine storm with no known adverse
      reactions. Cellular Sciences received Orphan Drug Designations for Pulmonary Fibrosis and
      Cystic Fibrosis. Mice studies conducted by Dr. Lupfer at Missouri State University
      substantiated our finding by testing nebulized sodium pyruvate in flu (influenza A H1N1
      virus) infected mice that decreased morbidity, weight loss, proinflammatory cytokines, and
      decreased viral titers (virus numbers) compared to the Placebo Control. Additionally, treated
      mice consumed more chow during infection indicating improved symptoms (same results reported
      in a pilot mice COVID-19 study). There were notable improvements in pro-inflammatory cytokine
      production (IL-1β) and lower virus titers (viral numbers) on days 7 post infection in mice
      treated with Sodium pyruvate compared to the Placebo Control animals. As pyruvate acts on the
      host immune response, metabolic pathways and not directly on the virus, our data demonstrate
      that sodium pyruvate is a promising treatment option that is safe, effective, and unlikely to
      elicit antiviral resistance. Furthermore, we have preliminary data that suggest it may work
      similarly during other respiratory virus infections including COVID19/SARS-CoV-2.

      In a Phase III Placebo Controlled Clinical Trial with Idiopathic Pulmonary Fibrosis Patients,
      inhaled sodium pyruvate, a Non-Steroidal Nasal Spray (N115) demonstrated a statistically and
      clinically significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (from 52% to 86%), and
      a statistically and clinically significant reduction in coughing, hypoxemia and a reduction
      in nasal and lung inflammation. Inhaled sodium pyruvate alleviated the symptoms associated
      with the COVID-19 infections in Patients with COPD and Pulmonary Fibrosis. Nasal Nitric Oxide
      reduces the rate, duration and severity of viral infections in healthy young children and in
      healthy adults from the Flu, Rhinovirus and Coronavirus. The literature has reported that
      Nitric Oxide is elicited and inhibits viral replication in pigs infected with porcine
      respiratory coronavirus. Additionally Nasal Nitric Oxide levels decreases from normal levels
      found in healthy adults, in patients with asthma (87%), COPD (73%) CF (44%) and Primary
      Ciliary Dyskinesia (7%). The rate of infections increases with decreasing levels of nasal
      nitric oxide. Young children, 6-17 years of age, produce (142%) more nitric oxide than
      healthy adults, which may explain their resistance to COVID-19. Recently, researchers
      announced that a high percentage of COVID-19 infected patients that were hospitalized were
      Diabetics or were Pre-Diabetic. The literature has reported that elevated levels of glucose
      in patients with diabetes mellitus cause a deficiency in the production of nitric oxide by
      blunting nitric oxide synthesis, which may explain their susceptibility to COVID-19. Sodium
      pyruvate increases nitric oxide and is safe for use by Patients with Diabetes. The inhalation
      of nasal sodium pyruvate increased the synthesis of nasal nitric oxide to normal levels in
      patients with low levels of nitric oxide to increase all lung functions and decrease the rate
      of infections.

      A clinical survey of 367 patients who took a nasal spray similar to EmphyCorp' s N115
      formula, over a two-year period demonstrated a statistically significant decrease in the
      number, symptoms, and severity of seasonal flu respiratory tract infections. The number of
      flu or colds was reduced by 70% in Children and approximately 52% in Pregnant Women, Patients
      with Allergic Rhinitis, Diabetes, and Pulmonary Fibrosis. It has been used successfully by
      over 2 million patients globally in over 200 hospitals during the past 5 years to treat nasal
      and lung inflammation, congestion in Patients with COPD, Allergic Rhinitis, Pulmonary
      Fibrosis, sinusitis, the flu and Cystic Fibrosis, with no adverse events reported. It has
      been used by Children, Diabetics, and Hypertensives, with efficacy and with no known side
      effects. It has even been shown to be safe for use by Pregnant Women, for whom steroids are
      contraindicated as they increase the risk of low birth-weight babies.

      Proactive treatments with sodium pyruvate are not toxic and could be of benefit to children
      that are afflicted by many respiratory viruses and as a potential treatment for COVID long
      haulers.
    

Intervention name(s): Sodium Pyruvate; Saline
Intervention type(s): Drug; Other
Intervention description(s): Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.; Subjects will use a saline nasal spray 3x daily for 14 days.
Other intervention name(s): N115
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 15 COVID-19 infected patients will be assigned to the placebo and 15 COVID-19 infected patients assigned to the drug treatment for a total of 30 patients.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment