Status:
COMPLETED
Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection
Lead Sponsor:
Cellular Sciences, inc.
Collaborating Sponsors:
Missouri State University
Dynamic DNA Laboratories
Conditions:
COVID-19
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
PHASE3
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 includin...
Detailed Description
Inhibition of Viral Replication, Reduction of the "Cytokine Storm" and reduction of COVID-19 symptoms- Potential Treatment and Preventative for COVID-19 In numerous human clinical trials (17, phase I...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion Criteria
- 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.
- 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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Exclusion
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04824365
Start Date
April 12 2021
End Date
August 12 2022
Last Update
November 2 2022
Active Locations (2)
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1
Family First Medical Research Center
Virginia Gardens, Florida, United States, 33166
2
Missouri State University
Springfield, Missouri, United States, 65897