Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers.

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cellular Sciences, inc.
• Collaborators: Dynamic DNA Labs; Family First Medical Research Center; Missouri State University; Trinity Health Care

Criteria

Inclusion Criteria:

• A prior confirmed positive test for COVID19 and lingering symptoms are required for inclusion.

As outlined on the CDC website, lingering symptoms include:

• Tiredness or fatigue

• Difficulty thinking or concentrating (sometimes referred to as "brain fog")

• Headache

• Loss of smell or taste

• Dizziness on standing

• Fast-beating or pounding heart (also known as heart palpitations)

• Chest pain

• Difficulty breathing or shortness of breath

• Cough

• Joint or muscle pain

• Depression or anxiety

• Fever

• Symptoms that get worse after physical or mental activities

Exclusion Criteria:

• Viral infections other than COVID-19.

• Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina

• Pregnancy

• Females of childbearing potential age not on adequate contraception or lactating

• Subjects receiving systemic corticosteroid treatment within one month of Screening Visit

• Subjects Less than 18 years of age

• Hospitalization within last 6 months due to acute exacerbation of airway disease

• Subjects with a clinically significant abnormal chest x-ray within past 12 months

• Medication changes within one month of study entry

• Subjects who have participated in another investigation drug treatment study within the previous month.

• Subjects with a current history of alcohol or recreational drug abuse.

• Subjects who have taken dietary supplements containing pyruvate within 24 hours prior to the screening visit.