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NCT04871815 · ClinicalTrials.gov registry record · Phase 2
Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers.
A Phase 2 study, sponsored by Cellular Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT04871815 is a Phase 2 study that has completed, run by Cellular Sciences. The registered enrollment target is 22 participants.
The verdict
NCT04871815, a Phase 2 study, has completed, sponsored by Cellular Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study 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.
Interventions
- DRUG sodium pyruvate nasal spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-04-27 |
| Est. Completion | 2022-03-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04871815
The ClinicalTrials.gov registry entry for NCT04871815 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cellular Sciences, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which sodium pyruvate nasal spray is the first listed.
NCT04871815 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04871815 about?
NCT04871815 is a clinical study titled "Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers.". 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-...
What is the current status of trial NCT04871815?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2021-04-27. Estimated completion is 2022-03-07.
What interventions are being tested in trial NCT04871815?
The interventions under investigation include: sodium pyruvate nasal spray (DRUG).
Who is sponsoring clinical trial NCT04871815?
This trial is sponsored by Cellular Sciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
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