Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers.
Condition: Long COVID
MeSH terms: COVID-19; Post-Acute COVID-19 Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There are approximately 12 million Americans with COVID-19 Long Hauler Symptoms, including
      athletes. The symptoms include hypoxemia (low SaO2), fatigue, coughing/sneezing, dyspnea,
      trouble breathing, body aches, headaches. This chronic disease is referred to as COVID-19
      Long Haulers. 7-10% of COVID-19 long haulers are also at serious risk of developing Pulmonary
      Fibrosis. Conversely, patients with Pulmonary Fibrosis have an increased risk and
      susceptibility to COVID-19 infection, which can reach a mortality rate of 50%. In a Phase III
      Clinical Trial in patients in Pulmonary Fibrosis and Idiopathic pulmonary fibrosis, the
      inhalation of the sodium pyruvate nasal spray demonstrated a statistically and clinically
      significant improvement in all lung functions, compared to baseline, including an increase in
      FEV-1, SaO2, FVC, FEV-1/FVC ratios (from 52% to 86%) and a reduction in coughing and fatigue.
      EmphyCorp/Cellular Sciences Inc. has submitted over 17 human clinicals (Phase I, II, III
      including animal safety data) to the FDA, demonstrating that the inhalation of sodium
      pyruvate, significantly reduced respiratory and nasal Inflammation, including oxygen radicals
      and inflammatory cytokines including IL-6, that causes the so-called cytokine storm COVID-19
      patients. Thousands of patients treated with inhaled sodium pyruvate including patients with
      COPD, Pulmonary Fibrosis, CF, Allergic Rhinitis, Chronic Rhinitis, Sinusitis, and Flu,
      demonstrated statistically and clinically significant improvement in lung functions with no
      adverse events reported. This study will examine the effects of N115 (Sodium pyruvate nasal
      spray) treatment on the symptoms associated with COVID-19 Long Haulers.
    

Detailed description: 
      In numerous human clinical trials (17, phase I, II, III clinical trials) submitted to the
      FDA, for COPD, Pulmonary Fibrosis, CF, Allergic Rhinitis, Chronic Rhinitis, Sinusitis, and
      Flu 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 Saline
      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 Saline
      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 3.5 million patients globally in over 200 hospitals during the past 8 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.

      There are approximately 12 million Americans with COVID-19 Long Hauler Symptoms, including
      athletes. The symptoms include hypoxemia (low SaO2), fatigue, coughing/sneezing, dyspnea,
      trouble breathing, body aches, headaches. This chronic disease is referred to as COVID-19
      Long Haulers. 7-10% of COVID-19 long haulers are also at serious risk of developing Pulmonary
      Fibrosis. Conversely, patients with Pulmonary Fibrosis have an increased risk and
      susceptibility to COVID-19 infection, which can reach a mortality rate of 50%. In a Phase III
      Clinical Trial in patients in Pulmonary Fibrosis and Idiopathic pulmonary fibrosis, the
      inhalation of the sodium pyruvate nasal spray demonstrated a statistically and clinically
      significant improvement in all lung functions, compared to baseline, including an increase in
      FEV-1, SaO2, FVC, FEV-1/FVC ratios (from 52% to 86%) and a reduction in coughing and fatigue.
      EmphyCorp/Cellular Sciences Inc. has submitted over 17 human clinicals (Phase I, II, III
      including animal safety data) to the FDA, demonstrating that the inhalation of sodium
      pyruvate, significantly reduced respiratory and nasal Inflammation, including oxygen radicals
      and inflammatory cytokines including IL-6, that causes the so-called cytokine storm COVID-19
      patients. Thousands of patients treated with inhaled sodium pyruvate including patients with
      COPD, Pulmonary Fibrosis, CF, Allergic Rhinitis, Chronic Rhinitis, Sinusitis, and Flu,
      demonstrated statistically and clinically significant improvement in lung functions with no
      adverse events reported. This study will examine the effects of N115 (Sodium pyruvate nasal
      spray) treatment on the symptoms associated with COVID-19 Long Haulers.
    

Intervention name(s): sodium pyruvate nasal spray
Intervention type(s): Drug
Intervention description(s): Subjects will use a sodium pyruvate nasal spray 3x daily for 7 days.
Other intervention name(s): N115
Intervention model: Single Group Assignment
Intervention model description: All subjects will be monitored for 1 week without intervention to obtain a baseline for signs and symptoms associated with COVID19 Long Haulers. All subjects will then be monitored for an additional week for signs and symptoms of COVID19 Long Haulers while using the N115 sodium pyruvate nasal spray 3x daily for that week.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID19, Long Haulers