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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: Completed Phase 2 study, sponsored by Cellular Sciences.
NCT04871815 is a Phase 2 study that has completed, run by Cellular Sciences. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What the finished NCT04871815 record still lists
NCT04871815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which sodium pyruvate nasal spray is the first listed.
NCT04871815 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04871815's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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