Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of Covid 19: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of Covid 19 (NCT04425863), a registered phase not stated study. The primary outcome is Patients Who Improved Their Condition or Did Not Worsen it.

2. Clinical Question

The study’s stated purpose concerns combinations and doses of ivermectin, aspirin, dexamethasone and enoxaparin, and their association with disease impact, intensive care admission and mortality. The primary endpoint is narrower: it counts participants who did not move to a more severe stage or die within the specified timeframe. The available record does not establish whether every intervention description corresponds to a distinct treatment group, how participants came to receive an intervention, or whether participants were compared under the same conditions.

The record describes mild cases as rtPCR-positive participants with mild symptoms, including fever not above 38.5 °C, mild desaturation and other listed symptoms. Severe cases are described using combinations of severe symptoms or clinical signs of bilateral viral pneumonia. The moderate-case description includes symptom-based criteria, but the registry text does not provide a complete description of those criteria. These definitions help explain the stated disease categories; they do not, by themselves, establish how consistently severity was assessed or whether classification was blinded to treatment.

3. Trial Design

The registry identifies the study as NCT04425863, with the title “Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of Covid 19.” Eurnekian Public Hospital is listed as sponsor. The record reports enrollment of 167 and a status of COMPLETED. The listed start date is 2020-05-01 and the primary completion date is 2020-08-30.

The listed interventions are ivermectin with aspirin; ivermectin, dexamethasone and aspirin; and ivermectin, dexamethasone and enoxaparin. The third intervention description also mentions inpatient treatment with mechanical ventilation in the intensive care unit. These descriptions do not supply a complete treatment schedule, specify which participants received each combination, or give the doses and timing for every intervention. Details beyond those descriptions are not reported in the registry record.

The study record groups participants by mild, moderate and severe cases. It does not state an allocation method. In particular, it does not report random assignment, concealment, a control group assigned under a common protocol, or a like-for-like comparison. The intervention descriptions therefore should not be interpreted as proof of randomized treatment arms. The registry record itself cautions that the arms are not a like-for-like control comparison.

The primary outcome is the count of participants who did not progress to a more severe stage of disease or die over 7 days. The record lists 5 outcome measures and 3 analyses, but does not give the details of the other outcomes or the methods used for those analyses. The primary outcome results, including group counts and any estimated treatment contrast, are not reported in the registry record.

Although the study is marked completed, completion status does not supply missing outcome data or analysis details. A protocol description, detailed participant flow, treatment allocation by severity, sample-size justification, and statistical analysis plan are not reported in the registry record. Consequently, the available study description supports a summary of the stated design and endpoint, but not a reconstruction of how treatment groups were formed or how the primary question was statistically tested.

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

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Patients Who Improved Their Condition or Did Not Worsen it, measured over 7 days.

The primary endpoint counts participants who did not go to a more severe disease stage or die within 7 days. The definition accounts for the participant’s starting status: a person enrolled with mild disease would count as having avoided progression if they did not move to moderate or severe disease, while a person enrolled with moderate disease would count if they did not progress to severe disease or die. Participants already enrolled in a severe condition are included in the definition’s reference to death.

This kind of endpoint combines worsening and death into a single binary outcome: each participant either meets the definition or does not. It is intended to capture whether disease status remained stable or improved over the stated period, rather than measuring a single symptom or laboratory value. Because it uses baseline severity as the point of reference, interpretation depends on how disease stage was determined at enrollment and how progression was assessed afterward. Those assessment procedures are not reported in the registry record.

As a general statistical point, a binary endpoint can provide a direct count of participants meeting a clinically interpretable definition. However, combining progression and death means that the overall count does not by itself show which component occurred, or how often each occurred. The registry record does not report the primary endpoint counts, component-specific results, uncertainty intervals or a group comparison. The endpoint definition is available, but the observed result and its precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is binary because the registry defines each participant as either having avoided progression or death over 7 days, or not. General statistical explanation: binary outcomes are often reported as counts and proportions, with the number of participants assessed serving as the denominator. A group comparison may be expressed as a difference or ratio between groups, but those measures require clearly defined groups and observed outcome data. The registry record does not report the primary endpoint counts, denominators for that endpoint, comparative estimates, or confidence intervals, so none of those quantities can be assessed from this record.

What does a confidence interval tell the reader?

In general, a confidence interval describes the uncertainty associated with an estimated effect. Its width is influenced by the amount of information in the data and by the variability of the outcome. A narrow interval indicates greater precision than a wide interval, while an interval compatible with a range of effects may leave substantial uncertainty. The registry record does not report a primary outcome estimate or confidence interval, so the precision of any treatment effect is not reported in the registry record.

Why does the allocation method matter?

In general, random allocation aims to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics. When allocation is not stated, observed group differences may reflect who received each intervention, their starting disease severity, or other factors. Statistical adjustment can address some measured differences under appropriate assumptions, but it cannot guarantee removal of unmeasured confounding. Here, the record says allocation was not stated and describes the arms as not a like-for-like control comparison. It does not report a method for controlling confounding or a treatment-effect estimate. Therefore, a causal interpretation is not supported by the available record.

What does the composite endpoint capture?

In general, a composite endpoint combines multiple events into one outcome. It can summarize whether any component occurred, but the summary may conceal differences between components. In this study’s definition, progression to a more severe stage and death both contribute to whether a participant meets the endpoint. Separate counts for progression and death would help clarify what drove the composite result. Those primary-outcome component counts are not reported in the registry record.

How should the adverse-event counts be read?

The serious adverse-event values are counts of affected participants and participants at risk, grouped by disease severity. These are descriptive fields in the registry; the record does not provide an inferential comparison between groups or a definition of the safety observation period. General statistical explanation: small event counts can yield imprecise estimates, and a comparison can be difficult to interpret when groups differ in starting risk or treatment exposure. The posted safety counts should not be treated as evidence that an intervention caused an event, or that an absence of recorded events proves the absence of risk.

What information is needed to interpret analyses?

A statistical analysis plan commonly specifies the primary analysis population, the method for handling missing outcomes, the treatment contrast, adjustment variables, and the approach to multiple outcomes or repeated analyses. These details support interpretation by clarifying which data enter an estimate and how uncertainty is calculated. The registry record lists 3 analyses and 5 outcome measures, but does not report the methods used, the analysis populations, missing-data procedures, adjustment strategy, or multiplicity approach.

The record’s sample-size description states that its planning illustration is based on the observed effect, uses a two-sided significance level of 0.05, assumes equal allocation and a normal approximation, and uses the stated fraction of the observed effect as the effect to detect. This is a planning illustration, not the trial’s own sample-size justification. The trial’s sample-size justification is not reported in the registry record. Such planning figures do not constitute observed power and cannot replace a reported outcome analysis. The specific sample-size values are not reported in the registry record.

General statistical explanation: over-dispersion is relevant when observed variability in count data exceeds what a chosen model expects. It can make standard errors too small if the model does not account for the extra variability. The primary endpoint is defined as a participant count for a binary outcome, and the registry record does not report a count model or an over-dispersion analysis. There is therefore no basis for claiming that over-dispersion was assessed or was a concern in this study.

For an interpretable treatment-effect analysis, readers would need clear allocation and comparator definitions, outcome counts by group, analysis denominators, uncertainty estimates, and details of any adjustments. The registry record does not report these for the primary endpoint. Without them, statistical concepts can explain what a complete analysis would address, but cannot establish what this study’s unreported analysis found.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Mild Cases", "Moderate Cases", "Severe Cases")
n      <- c(135, 12, 20)
events <- c(135, 12, 19)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Mild Cases  135  135  100.0  97.3  100.0  97.2  100.0  97.3  100.0
ARM  Moderate Cases  12  12  100.0  73.5  100.0  75.8  100.0  75.3  99.8
ARM  Severe Cases  20  19  95.0  75.1  99.9  76.4  99.1  76.2  98.8

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 5 outcome measures and 3 analyses. It does not identify the complete set of hypotheses tested, which outcome was treated as primary for statistical testing beyond the endpoint designation, or whether any analysis plan controlled the chance of false-positive findings across multiple outcomes or analyses. A multiplicity adjustment or a prespecified hierarchy may be used in general to address the risks of examining several outcomes or analyses, but the method, if any, is not reported in the registry record. No significance claims can be evaluated without the results and the analysis plan.

Missing-data handling is also not reported in the registry record. The available information does not say how many participants had primary outcome data, whether any outcomes were missing, how missing observations were treated, or whether any sensitivity analyses were conducted. General statistical explanation: excluding participants with missing outcomes can affect an estimate if missingness is related to disease status or treatment, while imputation and other methods rely on assumptions that should be stated and examined. No such method or assumption can be attributed to this study from the record.

The primary analysis population is not reported in the registry record. It is therefore unclear which participants were included in each analysis, whether participants were analyzed according to an assigned intervention, or whether there were exclusions after enrollment. The allocation method itself is not stated, so an intention-to-treat analysis cannot be assumed. The record reports enrollment of 167, but does not report the primary endpoint denominator or participant flow through the analyses. These gaps limit assessment of both bias and precision.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: multiple organ failure (5.0%).

The registry record reports serious adverse-event counts by severity category. Mild cases have 0 affected participants among 135 at risk, and moderate cases have 0 affected participants among 12 at risk. Severe cases have 1 affected participant among 20 at risk. The corresponding death counts are 0 for mild cases, 0 for moderate cases, and 1 for severe cases. These are descriptive counts, not comparative estimates.

The record also names multiple organ failure as the top serious term and gives 5.0%. It does not explain the denominator for this percentage or how the term relates to the affected-participant counts. The term should not be used to infer a count or a treatment-specific risk. The registry record does not report a safety observation period or establish whether the reported serious events were considered related to an intervention.

In general, a low or zero observed count does not show that an event is impossible, and an observed event does not show that treatment caused it. Interpretation depends on the number and characteristics of participants observed, the completeness of event collection, the observation period and the comparison design. Those details are not fully reported in the registry record. The safety figures should therefore be read as recorded event counts within the stated severity categories, without causal interpretation.

13. What the Result Does, and Does Not, Mean

The record establishes that a study was completed, enrolled 167 participants and defined a primary outcome concerning disease progression or death over 7 days. It also describes interventions involving ivermectin, aspirin, dexamethasone and enoxaparin, and categorizes participants as having mild, moderate or severe cases. These details indicate the subject and broad outcome focus of the study.

The registry record does not report the primary outcome counts or an effect estimate. It therefore does not show how many participants met the endpoint in each group, whether any observed group difference was large or small, or how precisely an effect was estimated. There are no reported confidence intervals or p-values for the primary endpoint. The absence of those results means the central outcome cannot be interpreted from the registry record.

The record also does not state the allocation method and warns that the intervention groups are not a like-for-like control comparison. This matters because differences in severity or treatment selection may influence outcomes. Without a stated allocation method, comparable groups, or an adequate analysis addressing relevant differences, a treatment effect cannot be separated from other explanations.

The serious adverse-event and death counts provide limited descriptive safety information by severity category. They do not establish causation, and the record does not supply enough detail to interpret the multiple organ failure percentage as a treatment-specific rate. These safety fields do not answer the primary efficacy question.

General statistical interpretation: a study’s completion status, enrollment count and outcome definition are not substitutes for a reported result. A well-defined endpoint can make an analysis interpretable when the outcome data, comparison, denominators and uncertainty are also available. In this record, those primary analysis elements are not reported. The result therefore does not establish whether the interventions changed progression or mortality, in either direction.

14. Why This Trial Matters Statistically

This study is statistically notable because its primary endpoint is defined in relation to changing disease severity, with death included as an adverse outcome. Such an endpoint makes the starting clinical category relevant to how each participant’s status is judged. Interpretation depends not only on the endpoint definition, but also on consistent severity classification, clear follow-up and transparent reporting of each component.

The record also illustrates why treatment descriptions alone do not establish a valid comparison. It lists several intervention combinations and three disease categories, while stating that allocation was not reported and the arms are not a like-for-like control comparison. When participants are not known to have been assigned comparably, group differences can reflect baseline prognosis or treatment selection. That design information is essential to judging whether a statistical contrast can support a causal conclusion.

Another key statistical issue is reporting completeness. The registry gives a primary endpoint definition, enrollment information and some safety counts, but not the primary endpoint results, comparative estimates or uncertainty. Without those values, readers cannot judge effect size or precision. The stated outcome-measure and analysis counts also raise questions about how outcomes were selected and whether multiple analyses were considered, but the analysis plan is not reported.

These features matter because statistical interpretation relies on more than a p-value or a count. It requires a defensible comparison, a clear analysis population, a known denominator, appropriate handling of missing data and transparent uncertainty estimates. The registry record does not report these details for the primary outcome. Its main statistical lesson is the importance of complete registration results and methods alongside a clear endpoint definition.

15. 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 registry record does not report the primary endpoint results, including counts by group, denominators, comparative estimates or confidence intervals. This prevents assessment of the direction, magnitude and precision of any difference. The study is marked completed, but completion status alone does not provide the missing results.

Allocation is not stated, and the record cautions that the arms are not a like-for-like control comparison. No randomization method, comparator definition or approach to confounding is reported. The record therefore does not support a causal interpretation based on comparisons between the listed intervention descriptions.

The descriptions do not provide a complete account of treatment schedules, participant assignment, or treatment exposure by severity category. The moderate-case description is incomplete in the registry text, and the record does not report how severity was assessed over follow-up. The primary endpoint depends on progression between severity stages, so missing assessment details limit interpretation of how the endpoint was applied.

The registry record lists 5 outcome measures and 3 analyses but does not report the statistical analysis plan, multiplicity procedure, analysis populations, missing-data methods, or participant flow. The trial’s sample-size justification is not reported in the registry record. The available sample-size description concerns a planning illustration based on the observed effect, not the trial’s design justification.

Safety reporting is also limited: the observation period and event-attribution procedures are not stated, and the denominator for the 5.0% multiple organ failure term is not explained. The serious-event and death counts are descriptive and cannot establish a treatment relationship. These limitations are specific to the information available in the registry record and do not establish what may have been collected or analyzed outside it.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of Covid 19 — NCT04425863.
• Registry record last updated 2020-10-19; status last verified 2020-10.
• Results first posted 2020-10-19.
• 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.

19. Record Summary

NCT04425863 is listed as a completed study sponsored by Eurnekian Public Hospital, with 167 participants enrolled. The record gives a start date of 2020-05-01 and a primary completion date of 2020-08-30. It describes interventions involving ivermectin, aspirin, dexamethasone and enoxaparin, with participants categorized as mild, moderate or severe cases.

The primary endpoint counts participants who did not progress to a more severe disease stage or die over 7 days. The primary endpoint results and the statistical comparison are not reported in the registry record. Allocation is not stated, and the record cautions that the arms are not a like-for-like control comparison.

Serious adverse-event counts are reported by severity category, as are deaths. The record also lists multiple organ failure as the top serious term at 5.0%, without explaining its denominator. These figures are descriptive and do not establish causation. The analysis methods, missing-data procedures, analysis populations and trial sample-size justification are not reported in the registry record.