CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Sodium Pyruvate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04824365
NCT04824365Phase 3Completed

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

Cellular Sciences, inc.·interventional·Posted Apr 1, 2021·Updated Nov 2, 2022

In Brief

A Phase 3 clinical trial evaluating Sodium Pyruvate and Saline for COVID-19. Completed, enrolled 30 participants across 2 sites.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedApr 1, 2021
Enrollment StartApr 12, 2021
Primary CompletionAug 12, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.3 years ago

Interventions

Sodium Pyruvatedrug

Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.

Salineother

Subjects will use a saline nasal spray 3x daily for 14 days.