Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection

NCT04824365 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CSI-COVID-19_007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Cellular Sciences Inc has submitted over 17 human clinicals (phase I, II, III including animal safety data) to the FDA for the reduction of respiratory inflammation and inflammatory cytokines including IL-6 the cause of the cytokine storm in COVID patients. These clinicals demonstrated a reduction of inflammation in all lung and sinus diseases, in patients with COPD, Pulmonary fibrosis, CF, asthma, sinusitis , the flu and nasal inflammation and congestion. Inhaled sodium pyruvate reduces inflammation, congestion and in our phase III clinical study with Idiopathic Pulmonary Fibrosis patients we demonstrated statistically and clinical significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (form 52% to 86%) and a decrease in hypoxemia, and a reduction in coughing. Inhaled sodium pyruvate alleviated the symptoms associated with COVID-19 patients in Pulmonary Fibrosis, and may be a solution to the lingering COVID-19 symptoms in patients that had the COVID-19 infection for example long haulers. In flu and COVID infected mice, nebulized sodium pyruvate decreased morbidity, weight loss, inflammatory cytokines and decreased viral titers compared to placebo controls. The study to be done at Missouri State University is titled ( Two week sub-chronic double-blinded placebo controlled trial designed to determine if sodium pyruvate nasal spray will reduce the symptoms, duration and replication of COVID-19 infection)

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers.

  RT-PCR was used to assess viral titers from nasal swabs from COVID19 patients. Swabs were collected and tested every 2 days for 14 days.

  Day 0, 2, 4, 6, 8, 10, 12, and 14

• Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect SaO2 in COVID-19 Infected Patients.

  Percent SaO2 was measured every other day by clinic staff.

  Day 0, 2, 4, 6, 8, 10, 12, and 14

Secondary Outcomes (9)

• Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients.

  Twice daily (morning and evening) from Day 1-14

• Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients.

  Daily from Day 1-14

• Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients.

  Daily form day 1-14.

• Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients.

  Daily from day 1-14.

• Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients.

  Daily from day 1-14.

Study Arms (2)

Treatment of COVID-19 infected patients with a sodium pyruvate nasal spray

EXPERIMENTAL

In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infection.

Drug: Sodium Pyruvate

Placebo control treatment of COVID-19 infected patients

PLACEBO COMPARATOR

In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVID-19 infection.

Other: Saline

Interventions

Sodium Pyruvate DRUG

Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.

Also known as: N115

Treatment of COVID-19 infected patients with a sodium pyruvate nasal spray

Saline OTHER

Subjects will use a saline nasal spray 3x daily for 14 days.

Placebo control treatment of COVID-19 infected patients

Eligibility Criteria

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

You may qualify if:

• Individuals with a confirmed COVID-19 viral infection, as determined by a qualified laboratory test. A nasal swab or saliva test analyzed by qPCR for COVID19.
• Individuals who agree to abstain from sexual intercourse, or agree to use condoms or vaginal diaphragms or other devices designed to prevent contraception, during the entire course of the study

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 child bearing 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 (2)

Family First Medical Research Center

Virginia Gardens, Florida, 33166, United States

Location

Missouri State University

Springfield, Missouri, 65897, United States

Location

Related Publications (2)

• Reel JM, Lupfer CR. Sodium Pyruvate Ameliorates Influenza A Virus Infection In Vivo. Microbiology Research. 2021; 12: 258-267.

  BACKGROUND

• 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

COVID-19

Interventions

BASS2 protein, Arabidopsis; Sodium Chloride

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The number of patients enrolled in this trial was small, thus decreasing the power of the statistical analysis.

Results Point of Contact

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

dr.martin@erols.com

9082371561

Study Officials

• Ronald Amen, Ph.D.

  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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 15 COVID-19 infected patients will be assigned to the placebo and 15 COVID-19 infected patients assigned to the drug treatment for a total of 30 patients.

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: April 12, 2021
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: November 2, 2022
• Results First Posted: September 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)