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

NCT04871815 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CSI-COVID-19_009
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID

Keywords

COVID19, Long Haulers

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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)

• 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)

Study Arms (1)

Treatment of COVID19 Long Haulers with sodium pyruvate nasal spray

EXPERIMENTAL

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.

Drug: sodium pyruvate nasal spray

Interventions

sodium pyruvate nasal spray DRUG

Subjects will use a sodium pyruvate nasal spray 3x daily for 7 days.

Also known as: N115

Treatment of COVID19 Long Haulers with sodium pyruvate nasal spray

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cellular Sciences, inc.: lead
• Missouri State University: collaborator
• Dynamic DNA Laboratories: collaborator
• Trinity Health System: collaborator
• Family First Medical Research Center: collaborator

Study Sites (1)

Missouri State University

Springfield, Missouri, 65897, United States

Location

Related Publications (1)

• 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.

  PMID: 32634445 BACKGROUND

Related Links

• Summary of previous clinical trials for sodium pyruvate

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Alain Martin
• Organization: Emphycorp/Cellular Sciences, inc.

dr.martin@erols.com

9082371561

Study Officials

• Ronald Amen, PhD

  VP of Regulatory Affairs

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 4, 2021
• Study Start: April 27, 2021
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: March 9, 2022
• Results First Posted: October 7, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)