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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 : Active, not recruiting
First Posted : May 4, 2021
Results First Posted : October 7, 2021
Last Update Posted : October 7, 2021
Sponsor:
Collaborators:
Missouri State University
Dynamic DNA Labs
Trinity Health Care
Family First Medical Research Center
Information provided by (Responsible Party):
Cellular Sciences, inc.

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, body aches, headaches. This chronic disease is referred to as COVID-19 Long Haulers. 7-10% of COVID-19 long haulers are also at serious risk of developing Pulmonary Fibrosis. Conversely, patients with Pulmonary Fibrosis have an increased risk and susceptibility to COVID-19 infection, which can reach a mortality rate of 50%. In a Phase III Clinical Trial in patients in Pulmonary Fibrosis and Idiopathic pulmonary fibrosis, the inhalation of the sodium pyruvate nasal spray demonstrated a statistically and clinically significant improvement in all lung functions, compared to baseline, including an increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (from 52% to 86%) and a reduction in coughing and fatigue. EmphyCorp/Cellular Sciences Inc. has submitted over 17 human clinicals (Phase I, II, III including animal safety data) to the FDA, demonstrating that the inhalation of sodium pyruvate, significantly reduced respiratory and nasal Inflammation, including oxygen radicals and inflammatory cytokines including IL-6, that causes the so-called cytokine storm COVID-19 patients. Thousands of patients treated with inhaled sodium pyruvate including patients with COPD, Pulmonary Fibrosis, CF, Allergic Rhinitis, Chronic Rhinitis, Sinusitis, and Flu, demonstrated statistically and clinically significant improvement in lung functions with no adverse events reported. This study will examine the effects of N115 (Sodium pyruvate nasal spray) treatment on the symptoms associated with COVID-19 Long Haulers.

Condition or disease Intervention/treatment Phase
Long COVID Drug: sodium pyruvate nasal spray Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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
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.

Information from the National Library of Medicine

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


Locations
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United States, Missouri
Missouri State University
Springfield, Missouri, United States, 65897
Sponsors and Collaborators
Cellular Sciences, inc.
Missouri State University
Dynamic DNA Labs
Trinity Health Care
Family First Medical Research Center
Investigators
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Study Director: Ronald Amen, PhD VP of Regulatory Affairs
  Study Documents (Full-Text)

Documents provided by Cellular Sciences, inc.:
Informed Consent Form  [PDF] April 20, 2021

Additional Information:
Publications:
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Responsible Party: Cellular Sciences, inc.
ClinicalTrials.gov Identifier: NCT04871815    
Other Study ID Numbers: CSI-COVID-19_009
First Posted: May 4, 2021    Key Record Dates
Results First Posted: October 7, 2021
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cellular Sciences, inc.:
COVID19, Long Haulers
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases