Status:
COMPLETED
Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers.
Lead Sponsor:
Cellular Sciences, inc.
Collaborating Sponsors:
Missouri State University
Dynamic DNA Laboratories
Conditions:
Long COVID
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
PHASE3
Brief Summary
There are approximately 12 million Americans with COVID-19 Long Hauler Symptoms, including athletes. The symptoms include hypoxemia (low SaO2), fatigue, coughing/sneezing, dyspnea, trouble breathing, ...
Detailed Description
In numerous human clinical trials (17, phase I, II, III clinical trials) submitted to the FDA, for COPD, Pulmonary Fibrosis, CF, Allergic Rhinitis, Chronic Rhinitis, Sinusitis, and Flu patients, inhal...
Eligibility Criteria
Inclusion
- A prior confirmed positive test for COVID19 and lingering symptoms are required for inclusion.
- As outlined on the CDC website, lingering symptoms include:
- Tiredness or fatigue
- Difficulty thinking or concentrating (sometimes referred to as "brain fog")
- Headache
- Loss of smell or taste
- Dizziness on standing
- Fast-beating or pounding heart (also known as heart palpitations)
- Chest pain
- Difficulty breathing or shortness of breath
- Cough
- Joint or muscle pain
- Depression or anxiety
- Fever
- Symptoms that get worse after physical or mental activities
Exclusion
- Viral infections other than COVID-19.
- Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina
- Pregnancy
- Females of childbearing 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.
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04871815
Start Date
April 27 2021
End Date
March 7 2022
Last Update
March 9 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Missouri State University
Springfield, Missouri, United States, 65897