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.


NCT ID:

NCT04871815


Primary Contact:

Study Director
Ronald Amen, PhD
VP of Regulatory Affairs

Christopher Lupfer, PhD
Phone: 417-836-6887
Email: christopherlupfer@missouristate.edu


Backup Contact:

Email: dr.martin@erols.com
Alain Martin, PhD
Phone: 908 237 1561


Location Contact:

Springfield, Missouri 65897
United States

Christopher Lupfer, Ph.D.
Phone: 417-836-6887
Email: Christopherlupfer@MissouriState.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: July 23, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.