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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cellular Sciences, inc.
• Collaborators: Dynamic DNA Labs; Family First Medical Research Center; Missouri State University; Trinity Health Care

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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