Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers.
|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: NCT04871815|
Recruitment Status : Completed
First Posted : May 4, 2021
Results First Posted : October 7, 2021
Last Update Posted : March 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Long COVID||Drug: sodium pyruvate nasal spray||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects will be monitored for 1 week without intervention to obtain a baseline for signs and symptoms associated with COVID19 Long Haulers. All subjects will then be monitored for an additional week for signs and symptoms of COVID19 Long Haulers while using the N115 sodium pyruvate nasal spray 3x daily for that week.|
|Masking:||None (Open Label)|
|Official Title:||Preliminary Examination of the Effects of Sodium Pyruvate Nasal Spray (N115) on Symptoms Associated With COVID19 Long Haulers.|
|Actual Study Start Date :||April 27, 2021|
|Actual Primary Completion Date :||March 7, 2022|
|Actual Study Completion Date :||March 7, 2022|
Experimental: Treatment of COVID19 Long Haulers with sodium pyruvate nasal spray
This is a single arm, open label study. All subjects will be provided a log for monitoring symptoms associated with Long COVID and asked to record symptom severity using a likert scale for one week. All subjects will then use N115 sodium pyruvate nasal spray 3x daily for an additional week and continue to log their symptoms.
Drug: sodium pyruvate nasal spray
Subjects will use a sodium pyruvate nasal spray 3x daily for 7 days.
Other Name: N115
- Change in the Symptoms of Long COVID-19 Patients [ Time Frame: 14 days ]A patient log was used to measure body ache, headache, chills, coughing/sneezing, sore throat, congestion, trouble breathing and other (patient supplied). The patients used a Likert scale from 0 to 10 to assess symptoms with 10 representing the most severe symptom and zero no symptom. The score for each individual symptom was combined into one overall symptom score for the 7 days of baseline (days 1-7) and a separate score for the 7 days of treatment (days 8-14). Therefore, a maximum 7-day score was 70 and a minimum of 0 was possible.
- Change in Body Temperature in Long COVID-19 Patients [ Time Frame: 14 days ]Body temperature will be measured twice daily by thermometer in degrees Fahrenheit. Average body temperature for the first 7 days (days 1-7) was used as a baseline with no treatment and was compared to the average body temperature for the next 7 days (days 8-14) with 20mM sodium pyruvate treatment.
- Change in Pulse Rate in Long COVID-19 Patients [ Time Frame: Day 1 (1st day Baseline), Day 8 (8th day Baseline), Day 8 (1st day Post-treatment) and Day 14 (7th day post-treatment) ]Patient heart rate will be measured as beats per minute.
- Change in Blood Oxygenation in Long COVID-19 Patients [ Time Frame: Day 1 (1st day Baseline), Day 8 (8th day Baseline), Day 8 (1st day Post-treatment) and Day 14 (7th day post-treatment) ]Blood oxygenation will be measured as %O2 saturation.
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|Ages Eligible for Study:||18 Years to 40 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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")
- 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
- Joint or muscle pain
- Depression or anxiety
- Symptoms that get worse after physical or mental activities
- Viral infections other than COVID-19.
- Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina
- 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.
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): NCT04871815
|United States, Missouri|
|Missouri State University|
|Springfield, Missouri, United States, 65897|
|Study Director:||Ronald Amen, PhD||VP of Regulatory Affairs|
Documents provided by Cellular Sciences, inc.:
|Responsible Party:||Cellular Sciences, inc.|
|Other Study ID Numbers:||
|First Posted:||May 4, 2021 Key Record Dates|
|Results First Posted:||October 7, 2021|
|Last Update Posted:||March 9, 2022|
|Last Verified:||March 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
COVID19, Long Haulers
Post-Acute COVID-19 Syndrome
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases