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Sodium Pyruvate Nasal Spray Treatment of COVID-19 and Influenza Infections

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04824365
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 29, 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.

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 and influenza infections)

Condition or disease Intervention/treatment Phase
Covid19 Influenza Drug: Sodium Pyruvate Other: Saline Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 15 patients will be assigned to the placebo and 15 patients assigned to the drug treatment for both COVID19 and influenza group, for a total of 60 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 and Influenza Infections
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: treatment of COVID-19 or influenza 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 COVIV-19 and influenza infections.
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 or influenza 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 COVIV-19 and influenza infections.
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 or influenza viral titers. [ Time Frame: 14 days ]
    RT-PCR will be used to assess viral titers from nasal swabs from COVID19 or influenza patients. Swabs will be collected and tested every 2 days for 14 days or until negative.

  2. Evaluate the ability of inhaled nasal sodium pyruvate to change the symptoms of COVID-19 or influenza. [ Time Frame: 14 days ]
    To evaluate the ability of the nasal spray to improve the symptoms from COVID19 or influenza, a patient log will be used. Signs and symptoms to be logged include fever, body ache, headache, chills, coughing/sneezing, sore throat, congestion, trouble breathing and other (patient supplied). Patients will use a Likert scales from 1 to 10 to assess signs and symptoms, except for fever, which will be recorded as temperature in degrees Fahrenheit. Blood pressure and pulse/Ox will be collected every 2 days by a nurse or PA at the time of nasal swab collection.



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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/influenza viral infection, as determined by a qualified laboratory test. A nasal swab or saliva test analyzed by qPCR for COVID19 or rapid flu test from nasal swab for influenza.
  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 or influenza.
  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 or flu 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


Contacts
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Contact: Christopher lupfer, Ph.D. 901 461 9215 Christopherlupfer@MissouriState.edu
Contact: Alain Martin, Ph.D. 908 237 1561 dr.martin@erols.com

Locations
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United States, Florida
Family First Medical Research Center Recruiting
Virginia Gardens, Florida, United States, 33166
Contact: Manuel M Lam, MD    786-665-9374    mmlam.pi.ff@gmail.com   
Contact: Barbara Rordriguez, ARPN    786-665-9374    barbara.family.pi@gmail.com   
United States, Missouri
Missouri State University Recruiting
Springfield, Missouri, United States, 65897
Contact: Christopher Lupfer, Ph.D.    417-836-6887    Christopherlupfer@MissouriState.edu   
Contact: Alain Martin    9082371561    dr.martin@erols.com   
Principal Investigator: Christopher lupfer, Ph.D.         
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
Last Update Posted: April 29, 2021
Last Verified: April 2021
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
Influenza, Human
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Orthomyxoviridae Infections