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

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ClinicalTrials.gov Identifier: NCT04871815
Recruitment Status : Active, not recruiting
First Posted : May 4, 2021
Results First Posted : October 7, 2021
Last Update Posted : October 7, 2021
Sponsor:
Collaborators:
Missouri State University
Dynamic DNA Labs
Trinity Health Care
Family First Medical Research Center
Information provided by (Responsible Party):
Cellular Sciences, inc.

Tracking Information
First Submitted Date  ICMJE April 27, 2021
First Posted Date  ICMJE May 4, 2021
Results First Submitted Date  ICMJE September 27, 2021
Results First Posted Date  ICMJE October 7, 2021
Last Update Posted Date October 7, 2021
Actual Study Start Date  ICMJE April 27, 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2021)
  • Change in the Symptoms of Long COVID-19 Patients [ Time Frame: 14 days ]
    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.
  • Change in Body Temperature in Long COVID-19 Patients [ Time Frame: 14 days ]
    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.
  • Change in Pulse Rate in Long COVID-19 Patients [ Time Frame: Day 1 (1st day Baseline), Day 8 (8th day Baseline), Day 8 (1st day Post-treatment) and Day 14 (7th day post-treatment) ]
    Patient heart rate will be measured as beats per minute.
  • Change in Blood Oxygenation in Long COVID-19 Patients [ Time Frame: Day 1 (1st day Baseline), Day 8 (8th day Baseline), Day 8 (1st day Post-treatment) and Day 14 (7th day post-treatment) ]
    Blood oxygenation will be measured as %O2 saturation.
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2021)
  • Change in the symptoms of Long COVID-19 patients [ Time Frame: 14 days ]
    A patient log with a Likert scale will be used by the patient to measure body ache, headache, chills, coughing/sneezing, sore throat, congestion, trouble breathing and other (patient supplied). The score for each individual symptom will be combined into one overall symptom score. Patients will use Likert scales from 1 to 10 to assess symptoms.
  • Change in body temperature in Long COVID-19 patients [ Time Frame: 14 days ]
    Body temperature will be measured twice daily by thermometer in degrees Fahrenheit.
  • Change in pulse rate in Long COVID-19 patients [ Time Frame: Day 1, 7, and 14 of the study ]
    Patient heart rate will be measured as beats per minute.
  • Change in blood oxygenation in Long COVID-19 patients [ Time Frame: Day 1, 7, and 14 of the study ]
    Blood oxygenation will be measured as %O2 saturation.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers.
Official Title  ICMJE Preliminary Examination of the Effects of Sodium Pyruvate Nasal Spray (N115) on Symptoms Associated With COVID19 Long Haulers.
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Long COVID
Intervention  ICMJE Drug: sodium pyruvate nasal spray
Subjects will use a sodium pyruvate nasal spray 3x daily for 7 days.
Other Name: N115
Study Arms  ICMJE Experimental: Treatment of COVID19 Long Haulers with sodium pyruvate nasal spray
This is a single arm, open label study. All subjects will be provided a log for monitoring symptoms associated with Long COVID and asked to record symptom severity using a likert scale for one week. All subjects will then use N115 sodium pyruvate nasal spray 3x daily for an additional week and continue to log their symptoms.
Intervention: Drug: sodium pyruvate nasal spray
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 27, 2021)
22
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2021)
50
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04871815
Other Study ID Numbers  ICMJE CSI-COVID-19_009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cellular Sciences, inc.
Study Sponsor  ICMJE Cellular Sciences, inc.
Collaborators  ICMJE
  • Missouri State University
  • Dynamic DNA Labs
  • Trinity Health Care
  • Family First Medical Research Center
Investigators  ICMJE
Study Director: Ronald Amen, PhD VP of Regulatory Affairs
PRS Account Cellular Sciences, inc.
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP