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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: Completed Phase 2 study of COVID-19, sponsored by Cellular Sciences.
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 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
RT-PCR was used to assess viral titers from nasal swabs from COVID19 patients. Swabs were collected and tested every 2 days for 14 days.
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 |
What the finished NCT04824365 record still lists
NCT04824365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04824365's enrollment target sits among peer trials
30 265th of 298 higher than 28 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 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.
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