Springfield, Missouri 65897

  • Long COVID

Purpose:

COVID-19 results in chronic disease in 10-30% of patients, including fatigue, brain fog, headache, difficulty breathing, dizziness, and more. This chronic disease is referred to as COVID-19 Long Haulers. Many of the signs and symptoms associated with Long Haulers are similar to those seen in COPD or pulmonary fibrosis patients, for which N115, the drug tested here, has already completed phase 3 clinical trials. This study will examine the effects of N115 (Sodium pyruvate nasal spray) treatment on the symptoms associated with COVID-19 Long Haulers.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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.


Study is Available At:


Original ID:

CSI-COVID-19_009


NCT ID:

NCT04871815


Secondary ID:


Study Acronym:


Brief Title:

Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers.


Official Title:

Preliminary Examination of the Effects of Sodium Pyruvate Nasal Spray (N115) on Symptoms Associated With COVID19 Long Haulers.


Overall Status:

Recruiting


Study Phase:

Phase 2/Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

40 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cellular Sciences, inc.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Ronald Amen, PhD
Study Director
VP of Regulatory Affairs
Primary Contact:Christopher Lupfer, PhD
417-836-6887
christopherlupfer@missouristate.edu
Backup Contact:Alain Martin, PhD
908 237 1561
dr.martin@erols.com

Study Dates

Start Date:April 27, 2021
Completion Date:June 2022
Completion Type:Anticipated
Primary Completion Date:May 2022
Primary Completion Type:Anticipated
Verification Date:April 2021
Last Changed Date:April 30, 2021
First Received Date:April 27, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in blood oxygenation in Long COVID-19 patients
Time Frame:Day 1, 7, and 14 of the study
Safety Issues:False
Description:Blood oxygenation will be measured as %O2 saturation.
Outcome Type:Primary Outcome
Measure:Change in pulse rate in Long COVID-19 patients
Time Frame:Day 1, 7, and 14 of the study
Safety Issues:False
Description:Patient heart rate will be measured as beats per minute.
Outcome Type:Primary Outcome
Measure:Change in body temperature in Long COVID-19 patients
Time Frame:14 days
Safety Issues:False
Description:Body temperature will be measured twice daily by thermometer in degrees Fahrenheit.
Outcome Type:Primary Outcome
Measure:Change in the symptoms of Long COVID-19 patients
Time Frame:14 days
Safety Issues:False
Description:A patient log with a Likert scale will be used by the patient to measure body ache, headache, chills, coughing/sneezing, sore throat, congestion, trouble breathing and other (patient supplied). The score for each individual symptom will be combined into o

Study Interventions

Intervention Type:Drug
Name:sodium pyruvate nasal spray
Description:Subjects will use a sodium pyruvate nasal spray 3x daily for 7 days.
Arm Name:Treatment of COVID19 Long Haulers with sodium pyru
Other Name:N115

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment of COVID19 Long Haulers with sodium pyruvate nasal spray
Description: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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Cellular Sciences, inc.
Agency Class:Other
Agency Type:Collaborator
Agency Name:Missouri State University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Abusalamah H, Reel JM, Lupfer CR. Pyruvate affects inflammatory responses of macrophages during influenza A virus infection. Virus Res. 2020 Sep;286:198088. doi: 10.1016/j.virusres.2020.198088. Epub 2020 Jul 4.
PMID:32634445

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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