This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection (NCT04824365), a randomized phase 2, phase 3 study. The primary outcome is Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04824365 |
| Phase | Phase 2, Phase 3 |
| Condition | COVID-19 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cellular Sciences, inc. |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned people with COVID-19. The registry record lists COVID-19 as the condition and reports enrollment of 30 participants. It does not report further eligibility details or a description of the study population’s characteristics.
Intervention
The intervention was N115 sodium pyruvate nasal spray. The arm description says participants were instructed to use the spray 3x daily for 14 days.
Comparator
The control group used a saline nasal spray as a placebo, also 3x daily for 14 days. The record describes the study as randomized, triple-masked, and parallel-group.
Primary question
The primary question was whether inhaled nasal sodium pyruvate changed COVID-19 viral titers, measured as Log10 viral RNA copies from nasal swabs. Swabs were scheduled for collection at Day 0, 2, 4, 6, 8, 10, 12, and 14. The registry record does not report numerical viral-titer results or an estimated difference between treatment groups, so the direction and precision of any treatment contrast cannot be assessed from the record.
The registry record also lists symptom-related secondary outcomes: fever, body aches, headaches, chills, coughing and sneezing, sore throat, congestion, and trouble breathing. These outcomes broaden the questions being considered beyond viral measurements. However, the presence of an outcome in a registry does not establish that results were collected, analyzed, or reported. Numerical results for these symptoms are not reported in the registry record.
3. Trial Design
The record describes a randomized, triple-masked, parallel-group trial listed as Phase 2 and Phase 3. It enrolled 30 participants and is marked completed. The start date is 2021-04-12, and the primary completion date is 2022-08-12. The sponsor is Cellular Sciences, inc. These registration details describe the planned trial structure and status; they do not by themselves establish what analyses were completed or what the results were.
Participants were assigned to sodium pyruvate nasal spray or saline nasal spray. The intervention description specifies use 3x daily for 14 days in each arm. Saline is identified as the placebo control. The primary outcome was viral titer measured from nasal swabs using RT-PCR, with collection scheduled every 2 days over the 14-day period. The registry record states that viral titers were assessed as Log10 viral RNA copies.
The entry also lists eight symptom-focused secondary outcomes covering fever, body aches, headaches, chills, coughing and sneezing, sore throat, congestion, and trouble breathing. It records 11 outcome measures and 11 analyses, but does not give numerical results for them. The method by which each symptom was measured, the statistical model used for the repeated viral-titer measurements, and the planned handling of missing observations are not reported in the registry record.
Although the record labels the trial completed, that status is not equivalent to evidence that every listed outcome was analyzed or that results were posted. Enrollment and the arm sizes in the adverse-event record indicate 15 participants at risk in each group. Further details about allocation procedures, masking roles, adherence, participant flow, and analysis populations are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | Placebo Control Treatment of COVID-19 Infected Patients |
|---|---|---|
| STARTED | 15 | 15 |
| COMPLETED | 15 | 15 |
| NOT COMPLETED | 0 | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | Placebo Control Treatment of COVID-19 Infected Patients | Total |
|---|---|---|---|---|
| Participants analysed | 15 | 15 | 30 | |
| Age, Continuous | years | 53.2 (SD 17.57) | 54.73 (SD 19.51) | 53.97 (SD 18.26) |
| Sex: Female, Male: Female | Participants | 11 | 12 | 23 |
| Sex: Female, Male: Male | Participants | 4 | 3 | 7 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 15 | 15 | 30 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 15 | 15 | 30 |
6. Primary Endpoint
The registry lists the primary outcome as Evaluate the Ability of Inhaled Nasal Sodium Pyruvate to Change COVID-19 Viral Titers., measured over Day 0, 2, 4, 6, 8, 10, 12, and 14.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Error |
| Unit | Log10 viral RNA copies |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns change in COVID-19 viral titers, expressed as Log10 viral RNA copies. RT-PCR was used to assess viral titers in nasal swabs. Samples were scheduled at Day 0, 2, 4, 6, 8, 10, 12, and 14, allowing repeated measurements across the treatment period.
Viral-titer measurement is a laboratory-based outcome rather than a direct report of how a participant feels. In general, repeated measurements can describe the course of a biomarker over time and can help compare trajectories between groups, provided that the analysis accounts appropriately for the correlation among measurements from the same participant. The specific model, treatment contrast, and summary of change used for this trial are not reported in the registry record.
The endpoint is recorded as a mean of a continuous measure, with dispersion described as standard error. A mean gives a group-level summary, while a standard error describes the uncertainty in estimating that mean. Neither term alone gives the treatment-group contrast or its uncertainty. To interpret whether groups differed, readers would need the estimated contrast, a confidence interval or other uncertainty measure, and the analysis method. Those numerical results are not reported in the registry record.
The scheduled viral samples and the listed symptom outcomes address different aspects of the study question. A laboratory measurement and a symptom assessment should not be treated as interchangeable evidence. The registry record does not report numerical findings for either the primary viral-titer endpoint or the secondary symptoms.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the trial’s design and endpoint description, but it does not provide numerical results for viral titers. There is no reported group mean, estimated between-group contrast, confidence interval, p-value, or time-specific treatment estimate in the record. Therefore, the effect’s direction, magnitude, and precision cannot be evaluated from the posted registry information. The listed primary outcome should not be mistaken for a reported result.
The primary endpoint is repeated over time, with nasal-swab assessments scheduled from Day 0 through Day 14 at two-day intervals. A suitable interpretation would depend on how the repeated observations were summarized or modeled, and on the comparison between the randomized groups. The statistical method and the numerical comparison are not reported in the registry record. A set of measurements at multiple times, even if available, would not by itself establish a treatment contrast without a defined analysis and uncertainty estimate.
The record lists eight symptom outcomes as secondary outcomes. Numerical results for these outcomes are not reported in the registry record. The record also identifies 11 outcome measures and 11 analyses, but this does not disclose which results were calculated, how outcomes were prioritized, or how any multiplicity was addressed. Those details matter because repeated measurements and several outcomes can generate numerous possible comparisons. In general, the more comparisons considered, the more important it is to distinguish prespecified primary questions from exploratory analyses and to understand any adjustment strategy.
The adverse-event record lists 15 participants at risk in each arm, with zero serious adverse events, zero other adverse events, and zero deaths in each. These figures describe the registry’s posted counts; they do not replace clinical outcome results or establish that no events occurred outside the recorded categories or reporting period. The record does not provide further details about collection, definitions, or follow-up for adverse events.
The trial is marked completed, but completion status does not supply missing estimates. The registry record does not report a sample-size justification, analysis population, missing-data approach, interim analyses, or a detailed statistical analysis plan. In the absence of outcome estimates and their uncertainty, it is not possible to assess whether the trial data support a precise comparison, whether the groups’ trajectories differed, or how robust any findings might be. No conclusion about the treatment’s effect follows from the design description or zero-event counts alone.
9. Statistical Methods Explained
Continuous outcomes and group summaries. The primary outcome is a continuous measure: Log10 viral RNA copies. A mean summarizes the average observed measurement within a group, while a treatment comparison usually focuses on a difference between groups or a difference in change over time. The registry record identifies the outcome as a mean, but does not report the estimated group means or a treatment contrast. The reported dispersion type is standard error. In general, a standard error quantifies uncertainty in an estimated mean; it is not the same as the spread of individual participants’ measurements.
Repeated measurements. Viral-titer measurements were scheduled at Day 0, 2, 4, 6, 8, 10, 12, and 14. Measurements taken from the same participant are generally correlated: a person’s values across time are not independent observations. In general, an analysis of repeated measurements should account for this within-participant correlation. Different approaches can target different questions, such as a difference at a particular time or an overall difference in trajectories. The registry record does not report which approach was used, what comparison was primary within the measurement schedule, or how time was represented in the analysis.
Confidence intervals and p-values. In general, a confidence interval gives a range of estimates compatible with the data under the assumptions of the analysis. Its width conveys precision: narrower intervals indicate greater precision than wider intervals. A p-value describes how compatible the observed data are with a specified null model, conditional on the analysis assumptions; it does not measure the size or clinical importance of an effect. The registry record does not report confidence intervals or p-values for the primary outcome. Without an estimate and uncertainty measure, the precision of a treatment comparison cannot be judged.
Distribution and model assumptions. In general, a statistical model relies on assumptions about the outcome distribution, errors, and dependence among observations. Log-transformed viral measurements may have different statistical properties from measurements on their original scale, but the record does not describe transformations beyond expressing the unit as Log10 viral RNA copies. It also does not report model diagnostics, covariate adjustment, or the handling of values outside the assay’s measurable range. Such details should not be inferred from the endpoint label alone.
Over-dispersion. In general, over-dispersion occurs when observed variability is greater than a model assumes. If a model underestimates variability, its standard errors can be too small and its intervals too narrow. This concept is especially relevant when the model’s distributional assumptions do not match the data. The registry record does not report whether over-dispersion was assessed or whether any correction was used. It is therefore not possible to determine its relevance to this analysis from the record.
Planning illustrations. A sample-size calculation is a planning exercise, not a trial result. The stated assumptions describe illustrations based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. In general, planning calculations show how a hypothetical effect and analysis assumptions relate to the number of participants needed for a target power. They do not describe the power actually achieved after observing the data, and they cannot substitute for an effect estimate or confidence interval. The trial’s own sample-size justification is not reported in the registry record. Numerical planning values are not reported in the registry record.
Recalculation and analysis provenance. Recalculated estimates, when available, are simple unadjusted calculations from posted summary statistics; they are not substitutes for a sponsor’s prespecified analysis. No recalculated primary treatment comparison is available from the registry record because numerical outcome summaries are not reported. The registry record also does not report a sponsor analysis of the primary endpoint that can be compared with an unadjusted recalculation.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary viral-titer outcome alongside eight symptom-focused secondary outcomes. It also records 11 outcome measures and 11 analyses. Considering several outcomes and multiple scheduled measurements creates multiple possible statistical comparisons. In general, multiplicity can increase the chance that at least one comparison appears statistically notable by chance when many tests are conducted. Researchers may address this through a prespecified hierarchy, adjustment procedures, or a clear distinction between confirmatory and exploratory analyses.
The approach to multiplicity is not reported in the registry record. The record does not state whether the symptom outcomes were tested separately at each assessment, combined into summary measures, or analyzed under a hierarchy. It also does not report whether the repeated viral-titer measurements were handled in one model or through separate time-specific comparisons. Without these details and the numerical results, the strength of evidence across outcomes cannot be assessed.
The method for handling missing data is not reported in the registry record. In general, missing observations can affect estimates when the likelihood of missingness is related to participant characteristics, outcomes, or treatment. Appropriate methods depend on the pattern and reason for missingness and on the assumptions made by the analysis. The record does not provide participant flow, the number of measurements available at each time, or the reasons for any missing samples.
The analysis population is also not reported in the registry record. The record does not specify whether analyses used all randomized participants, participants who received treatment, or another defined group. It does not report adherence or protocol deviations. These details are needed to understand which participants contributed to each estimate and how the analysis relates to the randomized comparison.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | 0 | 15 | 0.0% |
| Placebo Control Treatment of COVID-19 Infected Patients | 0 | 15 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | 0 of 15 |
| Placebo Control Treatment of COVID-19 Infected Patients | 0 of 15 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Treatment of COVID-19 Infected Patients With a Sodium Pyruvate Nasal Spray | 0 of 15 |
| Placebo Control Treatment of COVID-19 Infected Patients | 0 of 15 |
The adverse-event record lists 15 participants at risk in the sodium pyruvate group and 15 in the saline control group. For each arm, the record lists zero serious adverse events, zero other adverse events, and zero deaths. These are the posted event counts and denominators; they are not estimates of treatment effects.
A count of zero in a small group does not establish that the underlying risk is zero. In general, the precision of an event-rate estimate depends on the number of participants observed and the completeness and duration of safety monitoring. The registry record does not report additional follow-up details, the event-collection window, definitions for the event categories, or whether the counts reflect all participants throughout follow-up.
The serious-event and other-event counts should be read as distinct recorded categories, not as a complete account of every possible safety outcome. The record lists no serious adverse-event terms. The zero counts do not establish comparative safety, and they do not provide information about the trial’s viral-titer or symptom outcomes.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of sodium pyruvate nasal spray with saline, alongside a primary viral-titer endpoint and several symptom outcomes. It also reports the planned treatment frequency and duration and lists adverse-event counts for the two arms. These details allow readers to understand the broad design and the questions the study was intended to address.
However, numerical primary and secondary outcome results are not reported in the registry record. There is no reported treatment contrast, uncertainty interval, or statistical test for viral titers or symptoms. Consequently, the posted record cannot show the magnitude or precision of any difference between the groups. It cannot establish whether the treatment groups had different viral-titer trajectories or symptom outcomes.
The zero adverse-event counts should also be interpreted narrowly. They are the recorded counts in each arm, not proof that risk was absent, and the registry record does not report details about safety monitoring or follow-up. The trial’s completed status does not fill these information gaps.
In general, a treatment comparison is best understood using an effect estimate together with an uncertainty measure, relevant analysis details, and information about missing observations and participant flow. Those elements are not reported in the registry record. The design and endpoint descriptions should therefore be kept separate from evidence about outcomes. No claim that sodium pyruvate did or did not change viral titers or symptoms can be drawn from the posted registry information alone.
13. Why This Trial Matters Statistically
This trial raises a useful statistical question because its primary outcome is a laboratory measure collected repeatedly over time. Repeated measurements can characterize how an outcome changes during a study, but they require an analysis that recognizes observations from the same participant are related. The registry record identifies the schedule and measurement scale, while leaving the analysis method and numerical results unreported.
The study also includes several symptom outcomes alongside the primary viral-titer endpoint. That creates an important interpretive distinction: a trial can ask multiple questions, but readers need to know which question was primary, how outcomes were analyzed, and how multiplicity was handled. Those details are not reported in the registry record, so the strength of evidence across the listed outcomes cannot be evaluated.
The modest enrollment of 30 participants also makes it especially important to see estimates and uncertainty rather than rely on a simple statement of trial completion. The record does not report the trial’s sample-size justification or numerical outcome results. Enrollment alone does not reveal how precisely the treatment contrast was estimated.
Finally, the record illustrates why registry design details and posted results serve different purposes. Randomization, masking, the comparator, endpoint definition, and sampling schedule describe how the study was structured. They do not establish what happened to participants’ outcomes. Without reported estimates, uncertainty, and analysis details, the statistical question remains open in this registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Important details needed to evaluate the trial are not reported in the registry record. These include participant eligibility criteria and baseline characteristics, allocation procedures, the specific roles covered by triple masking, participant flow, adherence, and protocol deviations. The record describes the study as completed but does not give a numerical account of how many participants completed follow-up or contributed data to each outcome.
The numerical results for the primary viral-titer endpoint and secondary symptom outcomes are not reported in the registry record. Consequently, there is no estimate or uncertainty measure to assess, and the direction, size, and precision of any group differences cannot be described. The specific statistical model, planned treatment contrast, missing-data approach, analysis population, and multiplicity procedure are also not reported in the registry record.
The primary endpoint schedule includes repeated nasal-swab measurements, but the record does not report the number of samples available at each assessment or how any incomplete series was handled. It does not describe the assay’s measurement range, quality-control procedures, or handling of values that could not be quantified. These details may affect interpretation of a laboratory endpoint but cannot be inferred from the outcome description.
The adverse-event record contains zero counts in each listed category for both arms, but provides no further description of monitoring duration, event definitions, or completeness. The registry record does not report a sample-size justification, interim analyses, or a detailed statistical analysis plan. These omissions limit interpretation of both outcome and safety information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Sodium Pyruvate Nasal Spray Treatment of COVID-19 Infection — NCT04824365.
- Registry record last updated 2022-11-02; status last verified 2022-10.
- Results first posted 2022-09-26.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed randomized, triple-masked, parallel-group Phase 2 and Phase 3 trial of sodium pyruvate nasal spray versus saline in COVID-19. Enrollment was 30 participants. Both sprays were described for use 3x daily for 14 days. The primary outcome was mean Log10 viral RNA copies from nasal swabs scheduled at Day 0, 2, 4, 6, 8, 10, 12, and 14. Eight symptom outcomes were also listed.
Numerical results for the viral-titer endpoint and symptom outcomes are not reported in the registry record. The adverse-event entry lists 15 participants at risk in each arm and zero serious adverse events, zero other adverse events, and zero deaths in both arms. Details about the analysis method, missing data, analysis populations, multiplicity, and sample-size justification are not reported in the registry record.