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Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04824365
Recruitment Status : Completed
First Posted : April 1, 2021
Results First Posted : September 26, 2022
Last Update Posted : November 2, 2022
Sponsor:
Collaborators:
Missouri State University
Dynamic DNA Labs
Trinity Health Care
Family First Medical Research Center
Information provided by (Responsible Party):
Cellular Sciences, inc.

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)

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Sodium Pyruvate Other: Saline Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 12, 2021
Actual Primary Completion Date : August 12, 2022
Actual Study Completion Date : August 12, 2022


Arm Intervention/treatment
Experimental: Treatment of COVID-19 infected patients with a sodium pyruvate nasal spray
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
Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
Other Name: N115

Placebo Comparator: Placebo control treatment of COVID-19 infected patients
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
Subjects will use a saline nasal spray 3x daily for 14 days.




Primary Outcome Measures :
  1. Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. [ Time Frame: Day 0, 2, 4, 6, 8, 10, 12, and 14 ]
    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.

  2. Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect SaO2 in COVID-19 Infected Patients. [ Time Frame: Day 0, 2, 4, 6, 8, 10, 12, and 14 ]
    Percent SaO2 was measured every other day by clinic staff.


Secondary Outcome Measures :
  1. Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients. [ Time Frame: Twice daily (morning and evening) from Day 1-14 ]
    To evaluate the ability of the N115 nasal spray to improve fever in COVID19 patients oral measurement of body temperature was assessed every morning and every evening for 14 days. Reported values are the average daily body temperature.

  2. Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients. [ Time Frame: Daily from Day 1-14 ]
    Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.

  3. Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients. [ Time Frame: Daily form day 1-14. ]
    Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.

  4. Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients. [ Time Frame: Daily from day 1-14. ]
    Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.

  5. Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients. [ Time Frame: Daily from day 1-14. ]
    Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms. The symptoms of both coughing and sneezing were assessed on the same Likert scale for this Outcome Measure.

  6. Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients. [ Time Frame: Daily from day 1-14. ]
    Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.

  7. Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients. [ Time Frame: Daily from day 1-14. ]
    Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.

  8. Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients. [ Time Frame: Daily from day 1-14 ]
    Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.

  9. Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fatigue in COVID-19 Infected Patients. [ Time Frame: Daily from day 1-14. ]
    Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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

Exclusion Criteria

  1. Viral infections other than COVID-19.
  2. Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina
  3. Pregnancy
  4. Females of child bearing potential age not on adequate contraception or lactating
  5. Subjects receiving systemic corticosteroid treatment within one month of Screening Visit
  6. Subjects Less than 18 years of age
  7. Hospitalization within last 6 months due to acute exacerbation of airway disease
  8. Subjects with a clinically significant abnormal chest x-ray within past 12 months
  9. Medication changes within one month of study entry
  10. Subjects who have participated in another investigation drug treatment study within the previous month.
  11. Subjects with a current history of alcohol or recreational drug abuse.
  12. Subjects who have taken dietary supplements containing pyruvate within 24 hours prior to the screening visit.

Inclusion of Women and Minorities Every attempt will be made to include all genders, and minorities that present with an active COVID-19 infection that are not exempted due to exclusion criteria.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04824365


Locations
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United States, Florida
Family First Medical Research Center
Virginia Gardens, Florida, United States, 33166
United States, Missouri
Missouri State University
Springfield, Missouri, United States, 65897
Sponsors and Collaborators
Cellular Sciences, inc.
Missouri State University
Dynamic DNA Labs
Trinity Health Care
Family First Medical Research Center
Investigators
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Study Director: Ronald Amen, Ph.D. VP of Regulatory affairs
  Study Documents (Full-Text)

Documents provided by Cellular Sciences, inc.:
Informed Consent Form  [PDF] February 9, 2021

Additional Information:
Publications:
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Responsible Party: Cellular Sciences, inc.
ClinicalTrials.gov Identifier: NCT04824365    
Other Study ID Numbers: CSI-COVID-19_007
First Posted: April 1, 2021    Key Record Dates
Results First Posted: September 26, 2022
Last Update Posted: November 2, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases