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 Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers. (NCT04871815), a na phase 2, phase 3 study. The primary outcome is Change in the Symptoms of Long COVID-19 Patients.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04871815 |
| Phase | Phase 2, Phase 3 |
| Condition | Long COVID |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cellular Sciences, inc. |
| Results posted | Yes |
2. Clinical Question
Population
People with Long COVID enrolled in this study. The registry record lists an enrollment of 22. It describes symptom scoring during baseline days 1–7 and treatment days 8–14.
Intervention
Sodium pyruvate nasal spray at 20mM, used 3x daily during the treatment period described for the primary outcome.
Comparator
The same participants’ baseline symptom scores, recorded during a week without treatment. This is a within-participant before-and-after comparison, not a randomized control group.
Primary question
How did the combined symptom score during the treatment week compare with the score during the baseline week? The registry record names this as change in the symptoms of Long COVID-19 patients, measured over 14 days. It does not report the numerical change or its uncertainty.
The symptom log covered body ache, headache, chills, coughing or sneezing, sore throat, congestion, trouble breathing, and an additional symptom category recorded by participants. Each symptom was rated on a Likert scale from 0 to 10, where 10 represented the most severe symptom and zero represented no symptom. Ratings were combined into an overall score for each seven-day period.
This design can describe how recorded symptom scores differed across the two study periods for the enrolled participants. It cannot, by itself, distinguish a treatment-period change from changes that might have occurred over time for other reasons. The record does not report a randomized comparison group or masking. The numerical primary outcome results, including the size and precision of any change, are not reported in the registry record.
3. Trial Design
This was a completed, single-group, open-label study of sodium pyruvate nasal spray in people with Long COVID. The registry record lists the study phases as PHASE2 and PHASE3 and an enrollment of 22. Allocation is listed as not applicable, and masking is listed as none. The intervention is named sodium pyruvate nasal spray. The treatment-period description for the primary endpoint specifies 20mM sodium pyruvate used 3x daily.
The primary outcome compares symptom scores from two consecutive periods. Participants first recorded symptoms during baseline days 1–7 without treatment. They then used the nasal spray during days 8–14 and recorded symptoms for that period. The overall symptom score for each period was formed by combining the daily symptom ratings across the week. The endpoint timeframe is 14 days.
Because the baseline and treatment observations come from the same participants, the design has a repeated-measures character: each participant contributes scores for both periods. However, the registry record does not describe the statistical model or test used to analyze those paired observations. It also does not report whether all enrolled participants completed both periods or contributed data to the primary analysis.
The study is not a randomized comparison. There is no parallel group described as receiving a control intervention over the same period, and the baseline period is not a concurrent control. Participants knew whether they were receiving the nasal spray, since the study is listed as open label with no masking. These features matter when interpreting symptom ratings, which are reported by participants and can be affected by expectations or by changes over time unrelated to the intervention.
The registry record does not report the protocol’s sample-size justification, a planned enrollment target beyond the listed enrollment, or the details of any interim analyses. The record lists the study as completed and gives its start and primary completion dates as 2021-04-27 and 2022-03-07. The primary endpoint results themselves 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.
Before assignment: 22 patients were enrolled and served as their own baseline control for 7 days followed by 7 days of treatment.
Baseline Day 1-7
| Stage | No Treatment First Then Sodium Pyruvate Nasal Spray |
|---|---|
| STARTED | 22 |
| COMPLETED | 22 |
| NOT COMPLETED | 0 |
N115 Treatment Day 8-14
| Stage | No Treatment First Then Sodium Pyruvate Nasal Spray |
|---|---|
| STARTED | 22 |
| COMPLETED | 22 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Patient scores for baseline days 1-7 of the study when the patients received no treatment were summed into one baseline score (range 0-70). Patient scores for day 8-14 of the study when the patients received 3x daily treatment with 20mM sodium pyruvate were summed into a second score (range 0-70). A Mann-Whitney test was then used to assess statistical difference between baseline and treatment.
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 COVID19 Long Haulers With Sodium Pyruvate Nasal Spray |
|---|---|---|
| Participants analysed | 22 | |
| Age, Continuous | years | 31.68 (SD 9.25) |
| Sex: Female, Male: Female | Participants | 11 |
| Sex: Female, Male: Male | Participants | 11 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | Participants | 22 |
6. Primary Endpoint
The registry lists the primary outcome as Change in the Symptoms of Long COVID-19 Patients, measured over 14 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the change in symptoms of Long COVID-19 patients. Participants used a symptom log to rate body ache, headache, chills, coughing or sneezing, sore throat, congestion, trouble breathing, and other symptoms. Each rating used a Likert scale from 0 to 10, with 10 representing the most severe symptom and zero no symptom. Ratings were combined into an overall score for baseline days 1–7 and a separate overall score for treatment days 8–14.
The score for each seven-day period could range from 0 to 70, according to the registry description. A combined score is intended to capture overall reported symptom burden across the listed symptoms and days rather than focusing on a single symptom. Recording a baseline period and a treatment period allows a within-participant description of how scores changed across the study’s two weeks.
Such a measure is relevant to a study focused on symptoms because it reflects participants’ own assessments of symptom severity. At the same time, a combined score can conceal variation among individual symptoms: an overall change does not show whether every symptom changed in the same direction or to the same extent. The registry record does not report separate numerical results for the individual symptoms, nor does it report the numerical result for the combined primary endpoint. Further information about validation or a prespecified clinically meaningful change is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a symptom-score comparison between a baseline week without treatment and a week when participants used sodium pyruvate nasal spray. It does not report the numerical primary outcome result. In particular, the record does not give the mean score in either period, the mean change, a confidence interval, or a p-value for that endpoint. As a result, the direction, magnitude, and statistical precision of the primary result cannot be assessed from the registry information.
The design also limits what a before-and-after difference would establish, even if a numerical difference were available. All participants were observed first at baseline and then during treatment, without random allocation to a concurrent control group. Thus, the treatment period is inseparable from the passage of time and the fixed order of the study periods. Any score change could reflect the intervention, natural symptom fluctuation, changes in reporting, expectations, or other events during the study. The record does not describe methods to separate these possibilities.
Open-label measurement is particularly important for a subjective symptom endpoint. Participants knew when they were using the spray, and symptom severity was recorded by participants on a rating scale. General statistical interpretation: when outcome measurement depends on reported experience, expectations and awareness can influence recorded values. This does not establish that such influence occurred in this study; the registry record does not report an assessment of it.
The enrollment is listed as 22. That number indicates the recorded enrollment, not necessarily the number included in every endpoint analysis. The number with complete primary outcome data and the analysis population are not reported in the registry record. Without those details, the completeness and representativeness of the endpoint data cannot be assessed.
The record lists 15 analyses and 4 outcome measures, but it does not report how the primary result was analyzed or whether adjustments were made for multiple analyses or outcomes. The analysis count alone does not establish which results were prespecified, which were exploratory, or how multiplicity was addressed. The statistical plan is not reported in the registry record.
Overall, the registry record describes the study question and measurement approach, but does not report enough primary outcome results to quantify any observed change or its uncertainty. The single-group, open-label design would also require cautious interpretation of any before-and-after symptom difference and would not establish that the intervention caused a change.
9. Statistical Methods Explained
What does a symptom score represent?
The primary outcome combines participant ratings of several symptoms over a seven-day period. Each symptom was rated on a Likert scale from 0 to 10, where 10 represented the most severe symptom and zero no symptom. The registry describes summing the ratings into one overall score for baseline days 1–7 and another for treatment days 8–14. The possible range for each weekly score is 0–70.
General statistical explanation: a combined score reduces a set of ratings to a single summary, which can make an overall pattern easier to describe. However, the summary may hide differences among symptoms. A stable overall value could coexist with changes in particular symptoms, and a change in the overall value does not show which symptoms contributed to it. The registry record does not report numerical results for individual symptoms.
How should a before-and-after comparison be understood?
The same participants contributed baseline and treatment-period scores according to the endpoint description. General statistical explanation: when the same person is measured in two periods, the observations are paired rather than independent. An analysis that uses that pairing can account for the fact that a participant’s two scores are related. The registry record does not report whether the analysis used a paired method, what specific test or model was used, or how the endpoint was summarized in the results.
The period order is fixed: baseline comes first, followed by treatment. There is no randomized, concurrent comparison group described. General statistical explanation: a before-and-after comparison can show a temporal difference, but it does not by itself determine why the difference occurred. Without a concurrent control, changes over time and other influences cannot be cleanly separated from an intervention effect.
What would a confidence interval tell a reader?
General statistical explanation: a confidence interval describes the uncertainty around an estimated quantity, such as a mean change. A narrower interval indicates greater precision under the assumptions of the analysis; a wider interval indicates less precision. It can help readers judge which values are reasonably compatible with the data and analysis. The registry record does not report a confidence interval for the primary endpoint, so the precision of the estimated change cannot be assessed from this record.
A p-value, if reported, would address how compatible the data are with a specified statistical null model, given the analysis assumptions. It would not measure the size or clinical importance of a change, and it would not establish causation. The registry record does not report a primary endpoint p-value or the null hypothesis and test used.
Why does the analysis plan matter?
The registry record lists 4 outcome measures and 15 analyses. Those counts do not reveal which analyses were planned as primary, which were secondary or exploratory, or whether the analysis methods were selected before the data were examined. The statistical analysis plan is not reported in the registry record.
General statistical explanation: when many outcomes or analyses are considered, the chance of finding at least one apparently unusual result can increase if each is treated as a separate test. Multiplicity methods can address that issue, but different approaches answer different questions and can affect precision or interpretation. No multiplicity adjustment is reported in the registry record. It is therefore not possible to determine how the study handled multiple outcomes or analyses.
What do over-dispersion and distributional assumptions mean?
General statistical explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. It is especially relevant to some count outcomes, where an overly restrictive variance assumption can make uncertainty appear too small. The primary endpoint in this study is described as a continuous mean measure with standard deviation, not a count outcome. The registry record does not report an analysis model or evidence about whether its assumptions were checked. There is no basis in the record to claim that over-dispersion was assessed or was relevant to the primary analysis.
For a continuous score, analysts may consider how the score distribution and within-participant differences fit the chosen method. General statistical explanation: model assumptions matter because they affect estimated uncertainty and the validity of inferential statements. The registry record does not report distributional checks, transformations, robust methods, or sensitivity analyses.
What does a sample-size illustration mean?
Any sample-size figures associated with the record are planning illustrations computed from an observed effect, rather than the trial’s own design. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are hypothetical planning conditions, not a description of this single-group study’s enrollment process.
General statistical explanation: a sample-size calculation estimates the amount of information a future study might need under specified assumptions. Such a calculation is not observed power, and it does not show that the current study was adequately designed or that its findings are reliable. The registry record does not report its own sample-size justification. No sample-size illustration can substitute for the missing primary endpoint estimate, its uncertainty, or a clear account of the actual analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 4 outcome measures and 15 analyses. It does not identify the complete analysis hierarchy or state which analyses were prespecified, secondary, or exploratory. A statistical analysis plan is not reported in the registry record. It also does not report whether any adjustment for multiple outcomes or analyses was used. Without this information, the extent to which multiplicity was considered cannot be assessed, and the number of analyses alone should not be treated as evidence that a particular adjustment was or was not appropriate.
The primary outcome description specifies scores for baseline days 1–7 and treatment days 8–14, but the number of participants with data in each period is not reported in the registry record. The record does not report missing-data rates, reasons for missingness, or how incomplete symptom logs were handled. It does not state whether participants with partial records were included, excluded, or analyzed using an imputation method.
The enrollment is listed as 22, but the analysis population for the primary endpoint is not reported in the registry record. It is therefore unclear whether the reported enrollment and any endpoint analysis population would be the same. The record also does not report whether an intention-to-treat, per-protocol, or other analysis population was defined. These details are important because missing observations and participant exclusions can affect how representative an estimate is of the enrolled group.
Without results and analysis details, the effect of missing data or multiplicity on the interpretation cannot be quantified. The registry record does not report sensitivity analyses for either issue.
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 |
|---|---|---|---|
| Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray | 0 | 22 | 0.0% |
| Long COVID-19, No Treatment (Baseline) | 0 | 22 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray | 0 of 22 |
| Long COVID-19, No Treatment (Baseline) | 0 of 22 |
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 |
|---|---|
| Long COVID-19, Treatment With 20mM Sodium Pyruvate Nasal Spray | 0 of 22 |
| Long COVID-19, No Treatment (Baseline) | 0 of 22 |
The adverse-event record lists two groups: Long COVID-19 participants treated with 20mM sodium pyruvate nasal spray and the no-treatment baseline group. Each group lists 22 participants at risk for serious adverse events and 22 at risk for other adverse events. The record lists zero serious adverse events, zero other adverse events, and zero deaths in each group. No top serious-event terms are listed.
These figures describe what is recorded for the two periods; they do not constitute a randomized safety comparison. The baseline period is not a separate control group, and the same participants may contribute to both descriptions. The open-label, single-group design does not support treating the groups as independent arms.
Zero recorded events should be read as the registry’s reported count, not proof that the risk of an event is absent. General statistical explanation: when no events are observed in a study, the data still allow uncertainty about the frequency of events that could occur in a broader population. The registry record does not provide additional information about event-collection procedures or follow-up beyond the study period. The listed counts therefore describe recorded events in this study, not a definitive estimate of safety or a comparison of risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed study enrolled 22 people with Long COVID and assessed symptom scores before and during a week of sodium pyruvate nasal spray use. It gives a detailed description of the symptom log, the score scale, and the two seven-day periods. The primary outcome was designed to summarize participant-reported symptoms across those periods.
However, the registry record does not report the numerical primary outcome results. It does not provide the baseline or treatment-period scores, an estimated change, a confidence interval, or a p-value. Readers therefore cannot determine from this record whether the overall score increased or decreased, how large any change was, or how precise an estimate might be. It also does not report whether an observed score change met a clinically meaningful threshold.
Even if a before-and-after change were available, this study design would not establish that the spray caused it. Participants were not randomized to a concurrent control group, the baseline period always preceded treatment, and the study was open label. Changes in symptoms over time, expectations, or other factors could contribute to a change in reported scores. The registry record does not describe a design or analysis that separates those explanations.
The record’s safety entries list zero serious adverse events, zero other adverse events, and zero deaths in both the treatment and baseline descriptions. These are recorded counts in this study and should not be interpreted as proof that such events cannot occur.
In short, the record describes what the investigators set out to measure and how the main score was constructed, but it does not report the numerical primary outcome result needed to evaluate the observed symptom pattern. It also does not support a causal conclusion from the study design.
13. Why This Trial Matters Statistically
This study raises several useful statistical issues for clinical researchers. First, its primary outcome is a participant-reported composite score formed from several symptoms and multiple days. Such a measure can capture broad symptom burden, but interpretation depends on how the combined score is constructed and on whether readers can also understand changes in its components. The registry record describes the score construction but does not report individual symptom results or the numerical overall result.
Second, the study uses a within-participant baseline and treatment sequence. Repeated observations can be informative because each participant contributes data in both periods. Yet a fixed-order, single-group design cannot distinguish a treatment-period change from time trends or other explanations. The open-label approach also matters when the primary outcome is based on participant ratings. These considerations illustrate why design features and outcome measurement must be considered together when interpreting estimates.
Third, interpretation depends on reporting the estimate and its uncertainty, as well as the analysis population and handling of missing data. The registry record does not report the primary outcome estimate, a confidence interval, the analysis method, or the number of participants with complete endpoint data. Without these details, statistical significance, precision, and robustness cannot be evaluated.
Finally, the record lists multiple outcomes and analyses, while the multiplicity strategy is not reported. A transparent account of prespecification and analysis choices helps readers distinguish confirmatory results from exploratory findings. This record offers a clear example of why complete numerical results and analysis details are essential alongside a description of the study question and design.
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.
The primary limitation for interpreting the registry record is that it does not report numerical results for the primary endpoint. The reported scale and time periods clarify what was measured, but there is no reported mean, change estimate, confidence interval, or p-value. The numerical results for the other outcome measures are also not described in the information available in the registry record.
The single-group, open-label design has no randomized concurrent control group. Baseline measurement precedes treatment for all participants, so period effects and other changes over time cannot be separated from treatment-period changes. Participants knew when they were using the nasal spray, and the primary endpoint relied on self-reported symptom ratings. These design features limit causal interpretation.
The registry record lists enrollment of 22, but does not report the number included in the primary endpoint analysis or the completeness of symptom logs. Missing-data methods, analysis populations, and sensitivity analyses are not reported in the registry record. This prevents assessment of whether incomplete records or exclusions could affect the result.
The record lists 4 outcome measures and 15 analyses, but does not report which analyses were prespecified or whether multiplicity was addressed. It also does not report the primary analysis method, model assumptions, or a protocol-based sample-size justification. The symptom score combines multiple symptoms, and separate numerical results for its components are not reported. These limitations mean that the registry description supports understanding the measurement approach, but not a quantitative assessment of the primary outcome or a causal conclusion.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers. — NCT04871815.
- Registry record last updated 2022-03-09; status last verified 2022-03.
- Results first posted 2021-10-07.
- 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, open-label, single-group study of sodium pyruvate nasal spray in people with Long COVID. Enrollment is listed as 22, and the study phases are listed as PHASE2 and PHASE3. The primary outcome is change in a combined symptom score over 14 days, comparing baseline days 1–7 with treatment days 8–14. Participants rated symptoms from 0 to 10; the combined score for each seven-day period had a stated range of 0–70. The treatment-period description specifies 20mM sodium pyruvate used 3x daily.
The record lists zero serious adverse events, zero other adverse events, and zero deaths in both treatment and baseline descriptions. It lists 4 outcome measures and 15 analyses. Numerical primary outcome results, the analysis method, missing-data handling, analysis populations, and multiplicity procedures are not reported in the registry record. The single-group, fixed-order design does not provide a randomized concurrent comparison.