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 A Study of Auxora in Patients With Critical COVID-19 Pneumonia (NCT04661540), a randomized phase 2 study. The primary outcome is Change From Baseline in Combined CD4, CD8, and Monocyte Cell Population in BAL Fluid, as a Percent of Total WBC Population..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04661540 |
| Phase | Phase 2 |
| Condition | Pneumonia |
| Allocation | Randomized |
| Design model | Sequential |
| Masking | Single |
| Enrollment | 10 |
| Arms in the primary outcome | 4 |
| Lead sponsor | CalciMedica, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Patients with critical COVID-19 pneumonia. The registry lists pneumonia as the condition and reports enrollment of 10 participants. The primary outcome concerns immune cells measured in bronchoalveolar lavage fluid.
Intervention
Auxora, identified in the intervention list as CM4620-IE injectable emulsion, was administered in escalating-dose cohorts. The brief description states that the study could include up to 3 cohorts. The full dosing descriptions are incomplete in the registry record.
Comparator
Placebo. The registry identifies both Auxora and placebo as drug interventions and reports a randomized, single-blind design. Details about who was blinded are not reported in the registry record.
Primary question
What change from baseline was observed in the combined CD4, CD8, and monocyte cell population in bronchoalveolar lavage fluid, expressed as a percent of the total white blood cell population, after study-drug infusion? The registry describes this as a pharmacodynamic assessment of immune-cell response. It does not report an inferential comparison between Auxora and placebo.
3. Trial Design
This was a phase 2, randomized, single-blind, sequential dose-ranging study of Auxora in patients with critical COVID-19 pneumonia. The study was intended to include up to 3 escalating-dose cohorts and a placebo group. Its stated main goal was to assess pharmacodynamic parameters of immune response, with safety and tolerability also assessed.
The registry reports enrollment of 10. It lists primary-outcome results separately for Auxora Cohort 1, Auxora Cohort 2, Auxora Cohort 3, and placebo. The registry gives sample sizes of 3, 3, 1, and 2 for those outcome groups, respectively. These outcome-group counts do not explain how every enrolled participant contributed to the endpoint.
The study start date is 2021-03-02, and primary completion is listed as 2021-12-21. Its status is TERMINATED. A reason for termination is not reported in the registry record. The registry record does not report the planned allocation ratio, the process used to generate the random sequence, or which participants or study personnel were blinded.
Descriptions of the planned infusion regimens are present but incomplete, so the full cohort-specific dosing schedule cannot be reconstructed from the registry record. The reported endpoint results are descriptive group summaries. The registry record lists no analyses for the primary outcome and does not provide a formal treatment-effect estimate.
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: 10 patients were screened, 1 of which did not meet all inclusion/exclusion criteria, resulting in 9 patients randomized. All 9 completed study treatment, and 0 patients withdrew from the study. Patients were randomized 3:1 to Auxora or Placebo. The first 4 patients were enrolled in Cohort 1, and the next 4 in Cohort 2. The next 8 patients were to be enrolled in Cohort 3, but trial terminated early after the first patient was enrolled in Cohort 3, due to lack of new Covid-19 hospitalizations.
Period 1 (Cohort 1)
| Stage | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|
| STARTED | 3 | 0 | 0 | 1 |
| COMPLETED | 3 | 0 | 0 | 1 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Period 2 (Cohort 2)
| Stage | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|
| STARTED | 0 | 3 | 0 | 1 |
| COMPLETED | 0 | 3 | 0 | 1 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Period 3 (Cohort 3)
| Stage | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|
| STARTED | 0 | 0 | 1 | 0 |
| COMPLETED | 0 | 0 | 1 | 0 |
| NOT COMPLETED | 0 | 0 | 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.
Population: Due to low enrollment trial was terminated early, and Auxora-treated patients from all Cohorts were combined into one arm for analysis. All placebo-treated patients were combined into one control arm as planned.
| Characteristic | Unit | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 3 | 3 | 1 | 2 | 9 | |
| Age, Continuous | years | 53.0 (SD 5.2) | 67.0 (SD 3.0) | 46 (SD NA) | 54 (SD 1.4) | 57 (SD 8.4) |
| Sex: Female, Male: Female | Participants | 1 | 1 | 0 | 1 | 3 |
| Sex: Female, Male: Male | Participants | 2 | 2 | 1 | 1 | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 3 | 1 | 0 | 6 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 | 0 | 0 | 2 | 3 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 1 | 2 | 0 | 1 | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 1 | 1 | 0 | 4 |
| Region of Enrollment: United States | participants | 3 | 3 | 1 | 2 | 9 |
| Height | cm | 170.3 (SD 16.6) | 164.7 (SD 5.8) | 183 (SD NA) | 184.0 (SD 12.7) | 172.9 (SD 13.0) |
| Weight | kg | 96.7 (SD 26.5) | 78.0 (SD 4.4) | 163.4 (SD NA) | 103.5 (SD 26.2) | 99.4 (SD 30.9) |
| BMI | kg/m^2 | 33.2 (SD 6.6) | 28.9 (SD 1.6) | 48.9 (SD NA) | 30.3 (SD 3.6) | 32.9 (SD 7.3) |
| Number of Participants with Additional Prior Positive Covid Test: Yes | Participants | 3 | 3 | 0 | 1 | 7 |
| Number of Participants with Additional Prior Positive Covid Test: Unknown | Participants | 0 | 0 | 0 | 1 | 1 |
| Number of Participants with Additional Prior Positive Covid Test: No | Participants | 0 | 0 | 1 | 0 | 1 |
| Number of Participants with Upper Respiratory Co-detection of Sars-CoV-2 | Participants | 0 | 1 | 0 | 2 | 3 |
| Number of Participants with Bacterial Superinfection at Intubation | Participants | 1 | 1 | 0 | 0 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Combined CD4, CD8, and Monocyte Cell Population in BAL Fluid, as a Percent of Total WBC Population., measured over Baseline Assessment up to 120 hours.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percent of total WBC population |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change from baseline in the combined CD4, CD8, and monocyte cell population in bronchoalveolar lavage fluid, expressed as a percent of the total white blood cell population. The registry defines change as the post-infusion value minus the pre-infusion value. Samples were collected from bronchoalveolar lavage fluid before the first study-drug infusion and after infusion in Cohorts 1 and 2, or during the final 24 hours of the continuous infusion in Cohort 3.
Flow cytometry was used to assess the percentage of the total white blood cell population made up by the combined cell group. This is a pharmacodynamic endpoint: it describes a biological measurement associated with immune response, rather than a direct measure of how a participant felt or functioned. The combined measure brings the specified cell types together for a single outcome. A change can indicate that the measured proportion differed between the pre- and post-infusion assessments, but by itself it does not establish why the proportion changed or whether the change is beneficial.
The registry gives the timeframe as baseline assessment up to 120 hours. It does not report a clinically meaningful threshold for interpreting the size of a change. The endpoint is therefore best read as a descriptive measure of the observed immune-cell proportions, with the small group sizes and absence of reported inferential analysis kept in view.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports mean changes in the primary endpoint for each group. Auxora Cohort 1 had a mean of -5.6 with a standard deviation of 31.6, based on 3 participants. Auxora Cohort 2 had a mean of -7.2 with a standard deviation of 10.7, also based on 3 participants. Auxora Cohort 3 had a mean of 27.1, based on 1 participant; a standard deviation is not reported for that group. The placebo group had a mean of 22.8 with a standard deviation of 9.7, based on 2 participants.
These are within-group summaries, not estimates of a treatment effect comparing Auxora with placebo. The registry record lists zero analyses for this endpoint and indicates that values are missing or not estimable for a two-arm comparison of the continuous endpoint. No between-group estimate, confidence interval, or p-value is reported. Consequently, the posted results do not establish the size or precision of a randomized treatment contrast.
The group means vary in direction: the means for Auxora Cohorts 1 and 2 are negative, while the mean for Cohort 3 and the placebo mean are positive. With the very small group sizes, particularly the single participant in Cohort 3 and the 2 participants in placebo, these summaries are highly limited descriptions of the observed participants. The standard deviations also indicate the amount of observed spread in the groups where they are reported; they do not show how precisely a treatment effect has been estimated.
The study enrolled 10 participants, while the primary-outcome groups have the sample sizes. The registry record does not explain the relationship between total enrollment and the participants represented in these endpoint summaries. It also does not report how missing endpoint measurements were handled. This means the group summaries should not be treated as complete evidence about all enrolled participants.
The status is TERMINATED, but the reason for termination is not reported in the registry record. The posted data are therefore most appropriately interpreted as limited pharmacodynamic and safety descriptions from a small study, rather than as a definitive comparison of Auxora and placebo.
9. Statistical Methods Explained
The primary endpoint is a continuous measure: a numerical change in the percentage of total white blood cells represented by a combined cell population. For a continuous outcome, a mean describes the group’s average observed value, while a standard deviation describes how dispersed individual observations were around that average. These summaries answer different questions. The mean describes the group center; the standard deviation describes observed variability. Neither alone gives the uncertainty around a comparison between randomized groups.
The registry reports means and standard deviations for Auxora Cohorts 1 and 2 and placebo, and a mean without a standard deviation for Auxora Cohort 3. The missing standard deviation for Cohort 3 is consistent with the registry listing only 1 participant in that group; there is no within-group spread to estimate from a single observation. The available standard deviations are themselves based on small groups, so they should be read as descriptive rather than as stable estimates of variability in a wider population.
What would a treatment-effect estimate add?
A treatment-effect estimate would express the contrast between Auxora and placebo for the outcome, according to a specified analysis. A confidence interval would communicate the range of values compatible with the observed data and analysis assumptions, and its width would reflect precision. The registry record reports neither a treatment-effect estimate nor a confidence interval. It also reports no p-value for the primary endpoint. A reader therefore cannot use the posted outcome summaries to assess the statistical uncertainty of an adjusted or unadjusted between-group effect.
The registry record states that values are missing or not estimable for a two-arm comparison of the continuous endpoint. This is an explicit limitation on the available comparison, not evidence that the treatments are equivalent. The separate cohort means can be described, but they do not substitute for a prespecified comparison that accounts for the study design and the way participants were assigned.
How should the planning illustrations be read?
Planning illustrations use the observed effect as a reference and calculate sample-size requirements for detecting a stated fraction of that effect. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For time-to-event outcomes, the illustrations concern the total number of events; for other outcomes, they concern participants per arm. These are planning scenarios, not observed power and not the study’s actual design justification. The protocol’s sample-size justification is not reported in the registry record.
In general, sample-size planning depends on assumptions about the effect to detect, outcome variability, significance level, power, and allocation. If the observed effect comes from a very small study, using it as the planning reference may produce unstable illustrations. Planning calculations cannot establish that the study was adequately sized, and they do not turn descriptive results into evidence of a treatment effect.
Why can over-dispersion matter?
General statistical explanation: over-dispersion occurs when observed variability is greater than a model expects. If a method assumes less variability than the data contain, its uncertainty estimates can be too small and its conclusions too confident. The primary endpoint is continuous and is summarized with standard deviations; the registry record does not report a model or an analysis that addresses over-dispersion. This concept is relevant when selecting methods, but it cannot be used to infer what analysis the investigators performed.
For a small dose-ranging study, cohort membership also matters to interpretation. Separate cohort summaries preserve the displayed dose-group structure, but a comparison that combines or contrasts groups would need a clearly described estimand and analysis method. The registry record does not report such a method for this endpoint. It also does not report interim analyses, adjustment for baseline values, or covariate adjustment; these should not be assumed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures and 5 posted secondary outcomes. The secondary outcomes include immune-cell percentage in bronchoalveolar lavage fluid, survival at Day 60, and days alive and out of the intensive care unit, hospital, and off mechanical ventilation. The primary outcome is a pharmacodynamic immune-cell change. When several outcomes are assessed, the chance of at least one apparently unusual result can increase if each is tested separately. A prespecified testing strategy or multiplicity adjustment can help address that issue, but neither is reported in the registry record.
The registry lists zero analyses for the primary continuous endpoint and states that a two-arm comparison is not estimable from the posted values. It does not report a statistical analysis plan, a hierarchy for outcome testing, or whether any multiplicity procedure was planned or used. No inferential results for the secondary outcomes are included in the registry record described by the registry record.
Missing-data methods and reasons for missing measurements are not reported in the registry record. The registry reports enrollment of 10, while the primary outcome group sizes are 3, 3, 1, and 2. It does not explain whether every enrolled participant had an endpoint measurement, whether any measurements were excluded, or how the analysis population was defined. No intention-to-treat, per-protocol, or other analysis-population definition is reported. Without those details, it is not possible to determine how missingness or participant exclusions may have affected the summaries.
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 |
|---|---|---|---|
| Auxora (ALL) | 4 | 7 | 57.1% |
| Auxora Cohort 1 | 1 | 3 | 33.3% |
| Auxora Cohort 2 | 3 | 3 | 100.0% |
| Auxora Cohort 3 | 0 | 1 | 0.0% |
| Placebo | 2 | 2 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Auxora (ALL) | 4 of 7 |
| Auxora Cohort 1 | 2 of 3 |
| Auxora Cohort 2 | 2 of 3 |
| Auxora Cohort 3 | 0 of 1 |
| Placebo | 1 of 2 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Auxora (ALL) | 7 of 7 |
| Auxora Cohort 1 | 3 of 3 |
| Auxora Cohort 2 | 3 of 3 |
| Auxora Cohort 3 | 1 of 1 |
| Placebo | 2 of 2 |
Most frequent serious adverse event terms
| Event term | Organ system | Auxora (ALL) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 2 of 7 | 1 of 3 | 1 of 3 | 0 of 1 | 0 of 2 |
| Pulseless electrical activity | Cardiac disorders | 1 of 7 | 0 of 3 | 1 of 3 | 0 of 1 | 0 of 2 |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | 1 of 7 | 0 of 3 | 1 of 3 | 0 of 1 | 0 of 2 |
| Acute Kidney Injury | Renal and urinary disorders | 1 of 7 | 0 of 3 | 1 of 3 | 0 of 1 | 0 of 2 |
| Septic shock | Vascular disorders | 1 of 7 | 0 of 3 | 1 of 3 | 0 of 1 | 0 of 2 |
| Distributive shock | Vascular disorders | 1 of 7 | 1 of 3 | 0 of 3 | 0 of 1 | 0 of 2 |
| Acidosis | Metabolism and nutrition disorders | 0 of 7 | 0 of 3 | 0 of 3 | 0 of 1 | 1 of 2 |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 0 of 7 | 0 of 3 | 0 of 3 | 0 of 1 | 1 of 2 |
| Stridor | Respiratory, thoracic and mediastinal disorders | 0 of 7 | 0 of 3 | 0 of 3 | 0 of 1 | 1 of 2 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Auxora (ALL) | Auxora Cohort 1 | Auxora Cohort 2 | Auxora Cohort 3 | Placebo |
|---|---|---|---|---|---|---|
| Hypertransaminasemia | Hepatobiliary disorders | 4 of 7 | 2 of 3 | 1 of 3 | 1 of 1 | 1 of 2 |
| Enterobacter pneumonia | Respiratory, thoracic and mediastinal disorders | 4 of 7 | 1 of 3 | 3 of 3 | 0 of 1 | 0 of 2 |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | 4 of 7 | 2 of 3 | 2 of 3 | 0 of 1 | 0 of 2 |
| Venous thrombosis | Vascular disorders | 3 of 7 | 1 of 3 | 2 of 3 | 0 of 1 | 1 of 2 |
| Pneumonia staphylococcal | Respiratory, thoracic and mediastinal disorders | 2 of 7 | 1 of 3 | 0 of 3 | 1 of 1 | 1 of 2 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 2 of 7 | 1 of 3 | 1 of 3 | 0 of 1 | 1 of 2 |
| Blood creatine phosphokinase increased | Investigations | 1 of 7 | 1 of 3 | 0 of 3 | 0 of 1 | 2 of 2 |
| Pneumonia streptococcal | Respiratory, thoracic and mediastinal disorders | 2 of 7 | 0 of 3 | 1 of 3 | 0 of 1 | 0 of 2 |
| Eosinophilia | Blood and lymphatic system disorders | 1 of 7 | 0 of 3 | 1 of 3 | 0 of 1 | 0 of 2 |
| Arrhythmia | Cardiac disorders | 1 of 7 | 0 of 3 | 1 of 3 | 0 of 1 | 0 of 2 |
Serious events with the highest arm-level rate: acidosis (50.0%), respiratory failure (50.0%), stridor (50.0%), pulseless electrical activity (33.3%), gastrointestinal hemorrhage (33.3%).
The registry reports serious adverse events for 4 of 7 participants at risk in the combined Auxora group and 2 of 2 participants at risk in the placebo group. By Auxora cohort, the serious-event counts are 1 of 3 in Cohort 1, 3 of 3 in Cohort 2, and 0 of 1 in Cohort 3. The registry also reports deaths: 4 in the combined Auxora group, comprising 2 in Cohort 1, 2 in Cohort 2, and 0 in Cohort 3; 1 death is reported in placebo.
These are counts of participants with events, not estimates of a comparative safety effect. The registry record does not report whether serious events or deaths were judged related to study drug, the timing or duration of follow-up for these outcomes, or adjusted comparisons between groups. With small groups, a single participant’s event changes the group summary substantially. The listed serious-event terms and percentages should be read as registry descriptions, not as evidence of causation or as reliable comparative rates.
The registry lists Acidosis, Respiratory Failure, and Stridor at 50.0% each, and Pulseless electrical activity, Gastrointestinal hemorrhage, and Acute Kidney Injury at 33.3% each. The denominators and the relationship of these terms to individual participants are not explained in the registry record. Safety summaries therefore require caution, particularly when comparing groups of different and very small sizes.
12. What the Result Does, and Does Not, Mean
The posted primary-outcome data describe observed changes in the combined CD4, CD8, and monocyte population in bronchoalveolar lavage fluid for the listed Auxora cohorts and placebo. The group means differ in direction, and the reported standard deviations show observed variability for groups with more than one participant. The registry record does not provide a formal between-group estimate or its uncertainty.
These results do not establish that Auxora changed the endpoint more or less than placebo. They also do not establish that the groups were equivalent. A lack of a reported comparison is not a finding of no difference; it means the registry does not provide the statistical result needed to evaluate that question. The small group sizes limit how much can be inferred about patterns beyond the participants represented in the summaries.
The primary measure is pharmacodynamic, focused on an immune-cell proportion. It does not by itself establish a clinical effect on survival, time in intensive care, hospitalization, or mechanical ventilation. Those outcomes appear among the listed secondary measures, but results for them are not included in the registry record. No conclusion about clinical benefit or lack of benefit follows from the primary endpoint summaries alone.
The registry status is TERMINATED, but the reason for termination is not reported in the registry record. The posted safety counts are also descriptive and do not establish that events were caused by Auxora or placebo. Taken together, the record supports a narrow reading: a small randomized dose-ranging study reported group-level pharmacodynamic summaries and safety counts, while leaving the comparative statistical analysis and several interpretation details unavailable.
13. Why This Trial Matters Statistically
This study is statistically notable because it combines randomization with a sequential, dose-ranging structure and a pharmacodynamic primary endpoint. Randomization is intended to support fair comparisons by balancing factors across groups on average, but the registry record does not report a formal comparison for the primary outcome. The dose cohorts are reported separately, and the very small group sizes make each participant’s observation influential.
The outcome also illustrates a distinction between biological measurements and clinical outcomes. The primary endpoint measures a change in an immune-cell proportion in bronchoalveolar lavage fluid. That can describe a biological response, but it does not automatically answer whether participants experienced differences in clinical outcomes. The listed secondary outcomes include measures of survival and time alive outside intensive care, hospital, or mechanical ventilation, but their results are not reported in the registry record described by the registry record.
For biostatistical interpretation, the key issue is not only the direction of group means but the absence of an estimable two-arm analysis and uncertainty measures. Reporting a mean is not the same as reporting a treatment effect. In a small dose-ranging study, transparent methods for handling dose cohorts, missing measurements, and multiple outcomes are especially important; those methods are not reported in the registry record.
The study therefore illustrates why descriptive results, inferential comparisons, and planning calculations must be kept distinct. The posted summaries describe the observed participants, while the record does not supply the analysis needed to quantify a randomized treatment contrast. Planning illustrations based on an observed effect are not evidence of observed power or a substitute for a reported study-design rationale.
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 endpoint summaries are based on small groups, including a group with 1 participant and a placebo group with 2 participants. The registry record reports no standard deviation for the single-participant cohort, and it gives no confidence intervals for any group. These features limit assessment of variability and precision.
Although the study is described as randomized and single-blind, details of allocation generation, concealment, and who was blinded are not reported in the registry record. The planned dose descriptions are incomplete, and the record does not explain why the study was terminated. It also does not explain how enrollment of 10 relates to the participants represented in the primary endpoint summaries.
The registry does not report an inferential analysis for the primary endpoint, a between-group effect estimate, or a statistical analysis plan. Missing-data handling, analysis populations, baseline adjustment, and multiplicity procedures are not reported in the registry record. No clinically meaningful threshold for interpreting the primary outcome is reported. The listed adverse-event counts lack details about relatedness and timing. These limitations constrain both the precision and scope of conclusions that can be drawn from the posted results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Auxora in Patients With Critical COVID-19 Pneumonia — NCT04661540.
- Registry record last updated 2026-09-09; status last verified 2026-08.
- Results first posted 2025-11-21.
- 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
NCT04661540 is a phase 2, randomized, single-blind, sequential dose-ranging study of Auxora in patients with critical COVID-19 pneumonia. The registry lists enrollment of 10, a study start date of 2021-03-02, primary completion on 2021-12-21, and status TERMINATED. The stated aim was to assess pharmacodynamic immune response, safety, and tolerability.
The primary endpoint was change in the combined CD4, CD8, and monocyte population in bronchoalveolar lavage fluid as a percent of total white blood cell population. Group means and some standard deviations are reported, but the registry record lists no analyses for the endpoint and no estimable two-arm comparison. The reason for termination, analysis plan, missing-data methods, and definitions of analysis populations are not reported in the registry record. Safety results are posted as small-group event counts without reported attribution details.