Trial · NCT04824365
Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection
NCT04824365, Phase 2, Phase 3, Completed, Cellular Sciences, inc.; results first posted 2022-09-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection. Trials, record NCT04824365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04824365
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection
- NCT number
- NCT04824365
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Cellular Sciences, inc.
- Conditions
- COVID-19
- Interventions
- Sodium Pyruvate, Saline
- First posted
- 2021-04-01
- Last updated
- 2022-11-02
- Results first posted
- 2022-09-26
- Limitations and caveats
- The number of patients enrolled in this trial was small, thus decreasing the power of the statistical analysis.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. | Day 0, 2, 4, 6, 8, 10, 12, and 14 | 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. |
| Primary | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect SaO2 in COVID-19 Infected Patients. | Day 0, 2, 4, 6, 8, 10, 12, and 14 | Percent SaO2 was measured every other day by clinic staff. |
| Secondary | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients. | Twice daily (morning and evening) from Day 1-14 | To evaluate the ability of the N115 nasal spray to improve fever in COVID19 patients oral measurement of body temperature was assessed every morning and every evening for 14 days. Reported values are the average daily body temperature. |
| Secondary | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients. | Daily from Day 1-14 | Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms. |
| Secondary | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients. | Daily form day 1-14. | Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms. |
| Secondary | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients. | Daily from day 1-14. | Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms. |
| Secondary | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients. | Daily from day 1-14. | Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms. The symptoms of both coughing and sneezing were assessed on the same Likert scale for this Outcome Measure. |
| Secondary | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients. | Daily from day 1-14. | Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms. |
| Secondary | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients. | Daily from day 1-14. | Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms. |
| Secondary | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients. | Daily from day 1-14 | Patients self reported the symptom in a patient log daily for 14 days. A Likert scale from 0-10 was used to rank the symptom severity, with 10 representing the most severe symptoms. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. | Day 0, 2, 4, 6, 8, 10, 12, and 14 | Log10 viral RNA copies | MEAN | |
| PRIMARY | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect SaO2 in COVID-19 Infected Patients. | Day 0, 2, 4, 6, 8, 10, 12, and 14 | % Blood oxygen saturation | MEAN | |
| SECONDARY | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Fever in COVID-19 Infected Patients. | Twice daily (morning and evening) from Day 1-14 | Degrees Fahrenheit | MEAN | |
| SECONDARY | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Body Aches in COVID-19 Infected Patients. | Daily from Day 1-14 | Only patients that reported experiencing this symptom were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Headaches in COVID-19 Infected Patients. | Daily form day 1-14. | Only patients that reported experiencing this symptom were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Chills in COVID-19 Infected Patients. | Daily from day 1-14. | Only patients that reported experiencing this symptom were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Coughing and Sneezing in COVID-19 Infected Patients. | Daily from day 1-14. | Only patients that reported experiencing this symptom were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Sore Throat in COVID-19 Infected Patients. | Daily from day 1-14. | Only patients that reported experiencing this symptom were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Congestions in COVID-19 Infected Patients. | Daily from day 1-14. | Only patients that reported experiencing this symptom were included in the analysis. | units on a scale | MEAN |
| SECONDARY | Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Affect Trouble Breathing in COVID-19 Infected Patients. | Daily from day 1-14 | Only patients that reported experiencing this symptom were included in the analysis. | units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group284
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | Day 0 | 5.61 | Standard Error 0.26 | Log10 viral RNA copies |
| Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. | Placebo Control Treatment of COVID-19 Infected Patients | Day 0 | 6.57 | Standard Error 0.24 | Log10 viral RNA copies |
| Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | Day 2 | 4.67 | Standard Error 0.26 | Log10 viral RNA copies |
| Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. | Placebo Control Treatment of COVID-19 Infected Patients | Day 2 | 5.86 | Standard Error 0.20 | Log10 viral RNA copies |
| Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | Day 4 | 4.27 | Standard Error 0.26 | Log10 viral RNA copies |
| Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. | Placebo Control Treatment of COVID-19 Infected Patients | Day 4 | 5.18 | Standard Error 0.21 | Log10 viral RNA copies |
| Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | Day 6 | 3.88 | Standard Error 0.31 | Log10 viral RNA copies |
| Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. | Placebo Control Treatment of COVID-19 Infected Patients | Day 6 | 4.55 | Standard Error 0.22 | Log10 viral RNA copies |
| Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | Day 8 | 3.48 | Standard Error 0.34 | Log10 viral RNA copies |
| Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers. | Placebo Control Treatment of COVID-19 Infected Patients | Day 8 | 4.11 | Standard Error 0.20 | Log10 viral RNA copies |
1 to 10 of 284Source ClinicalTrials.gov
See all 284 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | 15 | |
| Overall Study | STARTED | Placebo Control Treatment of COVID-19 Infected Patients | 15 | |
| Overall Study | COMPLETED | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | 15 | |
| Overall Study | COMPLETED | Placebo Control Treatment of COVID-19 Infected Patients | 15 | |
| Overall Study | NOT COMPLETED | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | 0 | |
| Overall Study | NOT COMPLETED | Placebo Control Treatment of COVID-19 Infected Patients | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | 0 | 15 |
| Total, all-cause mortality | Placebo Control Treatment of COVID-19 Infected Patients | 0 | 15 |
| Total, other adverse events | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | 0 | 15 |
| Total, other adverse events | Placebo Control Treatment of COVID-19 Infected Patients | 0 | 15 |
| Total, serious adverse events | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | 0 | 15 |
| Total, serious adverse events | Placebo Control Treatment of COVID-19 Infected Patients | 0 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32634445 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray vs Placebo Control Treatment of COVID-19 Infected Patients: deaths from any cause | Trial comparisons |
| Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray vs Placebo Control Treatment of COVID-19 Infected Patients: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04824365
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