Long COVID Clinical Trial
Official title:
Preliminary Examination of the Effects of Sodium Pyruvate Nasal Spray (N115) on Symptoms Associated With COVID19 Long Haulers.
Verified date | March 2022 |
Source | Cellular Sciences, inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | March 7, 2022 |
Est. primary completion date | March 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Missouri State University | Springfield | Missouri |
Lead Sponsor | Collaborator |
---|---|
Cellular Sciences, inc. | Dynamic DNA Labs, Family First Medical Research Center, Missouri State University, Trinity Health Care |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the Symptoms of Long COVID-19 Patients | A patient log was used to measure body ache, headache, chills, coughing/sneezing, sore throat, congestion, trouble breathing and other (patient supplied). The patients used a Likert scale from 0 to 10 to assess symptoms with 10 representing the most severe symptom and zero no symptom. The score for each individual symptom was combined into one overall symptom score for the 7 days of baseline (days 1-7) and a separate score for the 7 days of treatment (days 8-14). Therefore, a maximum 7-day score was 70 and a minimum of 0 was possible. | 14 days | |
Primary | Change in Body Temperature in Long COVID-19 Patients | Body temperature will be measured twice daily by thermometer in degrees Fahrenheit. Average body temperature for the first 7 days (days 1-7) was used as a baseline with no treatment and was compared to the average body temperature for the next 7 days (days 8-14) with 20mM sodium pyruvate treatment. | 14 days | |
Primary | Change in Pulse Rate in Long COVID-19 Patients | Patient heart rate will be measured as beats per minute. | Day 1 (1st day Baseline), Day 8 (8th day Baseline), Day 8 (1st day Post-treatment) and Day 14 (7th day post-treatment) | |
Primary | Change in Blood Oxygenation in Long COVID-19 Patients | Blood oxygenation will be measured as %O2 saturation. | Day 1 (1st day Baseline), Day 8 (8th day Baseline), Day 8 (1st day Post-treatment) and Day 14 (7th day post-treatment) |
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