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NCT04824365 · ClinicalTrials.gov registry record · Phase 2
Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection
A Phase 2 study of COVID-19, sponsored by Cellular Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT04824365 is a Phase 2 study of COVID-19 that has completed, run by Cellular Sciences. The registered enrollment target is 30 participants, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04824365, a Phase 2 study of COVID-19, has completed, sponsored by Cellular Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
Cellular Sciences Inc has submitted over 17 human clinicals (phase I, II, III including animal safety data) to the FDA for the reduction of respiratory inflammation and inflammatory cytokines including IL-6 the cause of the cytokine storm in COVID patients. These clinicals demonstrated a reduction of inflammation in all lung and sinus diseases, in patients with COPD, Pulmonary fibrosis, CF, asthma, sinusitis , the flu and nasal inflammation and congestion. Inhaled sodium pyruvate reduces inflammation, congestion and in our phase III clinical study with Idiopathic Pulmonary Fibrosis patients we demonstrated statistically and clinical significant increase in FEV-1, SaO2, FVC, FEV-1/FVC ratios (form 52% to 86%) and a decrease in hypoxemia, and a reduction in coughing. Inhaled sodium pyruvate alleviated the symptoms associated with COVID-19 patients in Pulmonary Fibrosis, and may be a solution to the lingering COVID-19 symptoms in patients that had the COVID-19 infection for example long haulers. In flu and COVID infected mice, nebulized sodium pyruvate decreased morbidity, weight loss, inflammatory cytokines and decreased viral titers compared to placebo controls. The study to be done at Missouri State University is titled ( Two week sub-chronic double-blinded placebo controlled trial designed to determine if sodium pyruvate nasal spray will reduce the symptoms, duration and replication of COVID-19 infection)
Conditions Studied
Interventions
- OTHER Saline
- DRUG Sodium Pyruvate
Study Locations (2)
Florida
- Family First Medical Research Center - Virginia Gardens
Missouri
- Missouri State University - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-04-12 |
| Est. Completion | 2022-08-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04824365
The ClinicalTrials.gov registry entry for NCT04824365 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is Cellular Sciences, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT04824365 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT04824365 about?
NCT04824365 is a clinical study titled "Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection". Cellular Sciences Inc has submitted over 17 human clinicals (phase I, II, III including animal safety data) to the FDA for the reduction of respiratory inflammation and inflammatory cytokines including IL-6 the cause of the cytokine storm in COVID patients. These clinicals demonstrated a reduction o...
What is the current status of trial NCT04824365?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-04-12. Estimated completion is 2022-08-12.
What conditions does trial NCT04824365 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04824365?
The interventions under investigation include: Saline (OTHER), Sodium Pyruvate (DRUG).
Who is sponsoring clinical trial NCT04824365?
This trial is sponsored by Cellular Sciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04824365 being conducted?
This trial has 2 study locations across Florida, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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