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 Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment (NCT04673214), a randomized phase 3 study. The primary outcome is Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04673214 |
| Phase | Phase 3 |
| Condition | Covid19 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 114 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Gilberto Cruz Arteaga |
| Results posted | Yes |
2. Clinical Question
Population
Patients with mild-phase COVID-19 at U.M.F 13 and U.M.F 20 of the IMSS were the intended population. The registry lists COVID-19 as the condition and describes follow-up over 14 days followed by video call. It does not report further eligibility details in the available record.
Intervention
The triple-therapy group was assigned Azithromycin, Ivermectin, Ribaroxaban, and Paracetamol. The record's arm description includes medication instructions, but the description is truncated and does not give a complete regimen.
Comparator
The double-therapy group was assigned Azithromycin, Ribaroxaban, and Paracetamol, without Ivermectin in the intervention name. Its arm description is also truncated. The record does not report whether participants or clinicians knew which group was assigned.
Primary question
The stated primary outcome asks whether average days with COVID-19 symptoms differ between the double-therapy and triple-therapy groups during the 14-day timeframe. The registry describes Student's t test for this comparison. It does not report the group means, standard deviations, estimated difference, confidence interval, or test result.
3. Trial Design
The registry identifies NCT04673214 as a randomized, single-masked, parallel-group Phase 3 trial. It lists an enrollment of 114 and a completed status. The study start date is 2020-12-16, and the primary completion date is 2021-02-25. The sponsor is Gilberto Cruz Arteaga.
The comparison was between a triple-therapy regimen and a double-therapy regimen. Both intervention names include Azithromycin, Ribaroxaban, and Paracetamol; Ivermectin appears in the triple-therapy name. The registry's arm descriptions contain some dosing information, but both descriptions end before the regimen is fully specified. Details beyond the text in the record are not reported in the registry record.
The study summary describes patients with mild COVID-19 and a 14-day treatment and follow-up period followed by video call. The masking entry says single, but the record does not specify which people were masked. It does not report the method used to generate the random allocation sequence, how assignments were concealed, or how many participants were allocated to each group.
The registry lists 4 outcome measures and 5 analyses. Its primary outcome description refers to average days with symptoms, while the outcome information also indicates that the primary outcome has several categories or time points and is not reduced to one comparison. The arm-level results and the meaning of those categories or time points 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: There were no excluded patients.
Overall Study
| Stage | Triple Therapy | Double Therapy |
|---|---|---|
| STARTED | 67 | 47 |
| Lost to Follow up | 2 | 1 |
| COMPLETED | 65 | 46 |
| NOT COMPLETED | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%; A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis.
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: Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%; A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis.
| Characteristic | Unit | Double Therapy | Triple Therapy | Total |
|---|---|---|---|---|
| Participants analysed | 46 | 65 | 111 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 46 | 61 | 107 |
| Age, Categorical: >=65 years | Participants | 0 | 4 | 4 |
| Sex: Female, Male: Female | Participants | 24 | 34 | 58 |
| Sex: Female, Male: Male | Participants | 22 | 31 | 53 |
| Race/Ethnicity, Customized: Mestizo Mexicans | participants | 46 | 65 | 111 |
| Region of Enrollment: Mexico | Participants | 46 | 65 | 111 |
| Age: 21-30 years | Participants | 8 | 6 | 14 |
| Age: 31-40 years | Participants | 12 | 17 | 29 |
| Age: 41-50 years | Participants | 14 | 22 | 36 |
| Age: 51-60 years | Participants | 7 | 8 | 15 |
| Age: 61-70 years | Participants | 5 | 8 | 13 |
| Age: ≥ 71 years | Participants | 0 | 4 | 4 |
| Occupation: Part time | Participants | 2 | 11 | 13 |
| Occupation: Full time | Participants | 41 | 40 | 81 |
| Occupation: Housewife | Participants | 1 | 4 | 5 |
| Occupation: Pensioner | Participants | 2 | 9 | 11 |
| Occupation: Unemployed | Participants | 0 | 1 | 1 |
| Civil Status: Single | Participants | 12 | 13 | 25 |
| Civil Status: Married | Participants | 25 | 44 | 69 |
| Civil Status: Widower | Participants | 1 | 1 | 2 |
| Civil Status: Free Union | Participants | 7 | 5 | 12 |
| Civil Status: Divorced | Participants | 1 | 2 | 3 |
| Education: Primary | Participants | 2 | 1 | 3 |
| Education: High school | Participants | 3 | 9 | 12 |
| Education: Preparatory | Participants | 13 | 9 | 22 |
| Education: Technical career | Participants | 4 | 4 | 8 |
| Education: Degree | Participants | 21 | 32 | 53 |
| Education: Others | Participants | 3 | 10 | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS., measured over 14 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | days |
| Endpoint classification | Continuous Endpoint |
The primary outcome is titled “Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.” It is a continuous measure expressed in days, with the mean as the stated summary and standard deviation as the stated measure of dispersion. The timeframe is 14 days.
In general, counting days with symptoms can describe the duration of a clinical course, while comparing group averages can address whether symptom duration differs between assigned regimens. A mean conveys the central average across participants, and a standard deviation describes how spread out individual values are around that average. These summaries are most informative when their definitions and the relevant analysis population are clear.
The registry says that Student's t test was used for quantitative variables and identifies the comparison as double therapy versus triple therapy. However, the record does not report the group means, standard deviations, participant counts contributing to this outcome, or the estimated difference. It also does not explain how symptom days were defined or how the several categories or time points referenced in the outcome information relate to this stated average. The outcome's numerical result and its precision are therefore not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes the study question and design, but it does not give the numerical primary-outcome comparison. There are no arm-specific average symptom days or standard deviations reported in the registry entries, and no estimated difference, confidence interval, or p-value is reported. Consequently, the size, direction, and precision of any difference in average symptom duration cannot be described from this registry information.
The registry's outcome description says the comparison used Student's t test. That identifies a planned or reported analytical method, but it does not by itself establish what the results were. A test result without the group estimates would also be insufficient to understand the magnitude of a difference. Conversely, a numerical group difference would need an uncertainty estimate to show how precisely it was measured. Neither kind of primary-outcome result is reported in the registry record.
The study summary describes a proposed target of modification of the clinical course greater than or equal to 25%, and the primary-outcome population description refers to assuming 25% efficacy. These are statements in the study description, not reported treatment effects. The record does not state that the observed outcome met that target, nor does it supply an estimate against which the target could be assessed.
The record includes safety counts by group, but these do not fill the gap in the primary efficacy results. Serious adverse events are listed as 0 in each group, with 1 death in the dual-therapy group and 2 deaths in the triple-therapy group. Other adverse events are listed as 39 among 46 at risk in the dual-therapy group and 49 among 65 at risk in the triple-therapy group. The registry does not provide event definitions, timing, or explanatory detail alongside these counts. They should be read as recorded counts, not as a complete account of the clinical balance between groups.
Random allocation can support a fair comparison when allocation and follow-up are implemented and analyzed appropriately. The available record does not report enough detail to assess those processes, and the absent primary results prevent evaluation of the observed treatment contrast. Thus, the registry supports a description of the trial's design and stated outcome, but not a conclusion about the direction or magnitude of the primary comparison.
9. Statistical Methods Explained
What does the mean describe?
In general, a mean is the arithmetic average of observed measurements. For this outcome, the measurements are days with COVID-19 symptoms during a 14-day timeframe. A group mean gives a concise summary of symptom duration, but it does not show the full distribution: participants can have values above or below the average, and groups with the same mean can have different amounts of variation.
The registry names standard deviation as the dispersion measure. In general, standard deviation describes how spread out observations are around their group mean. It is not the uncertainty of the estimated mean itself. That uncertainty is commonly expressed using a confidence interval, which gives a range of values compatible with the data and the statistical assumptions. No confidence interval for this outcome is reported in the registry record.
What does a Student's t test assess?
The record says Student's t test was used for quantitative variables and specifically names the comparison of days with symptoms between double therapy and triple therapy. In general, a two-group t test assesses whether the observed difference between group means is large relative to the variability and amount of information in the data, under its assumptions. A p-value from such a test addresses compatibility with a specified null model; it is not a measure of clinical importance, and it does not quantify the probability that a treatment effect is true.
The registry does not report the test statistic, degrees of freedom, p-value, group summaries, or estimated mean difference. It also does not identify whether the test was conducted as a pooled-variance Student's t test or describe any alternative handling of unequal group variances. The method label alone is not enough to reconstruct or interpret the comparison.
Why do assumptions matter?
General statistical guidance is that a t test's interpretation depends on the measurement being meaningful, the observations being appropriately independent, and the sampling distribution of the mean difference being sufficiently well behaved for the test. The record does not describe checks of these assumptions. For a bounded count of symptom days, the possible values are constrained by the outcome definition and timeframe. If observations are strongly skewed or concentrated at a boundary, a simple mean-based analysis may not capture all relevant features. This is a general consideration, not a claim that such a pattern occurred in this trial.
In general, over-dispersion means that observed variability exceeds what a statistical model assumes. It can make uncertainty estimates too small if the model fails to account for it. The registry does not report a distributional assessment or over-dispersion analysis, and no claim about either can be made for these participants.
How should the planning statements be read?
The primary-outcome description says the planning assumptions included 25% efficacy in modifying the clinical course, power of 90%, a type I error rate of 1%, and 20% loss to follow-up. It states that a total of 62 patients was calculated, but the text ends after “however due” and does not complete the explanation. The reason for that qualification is not reported in the registry record.
Separately, the record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. In general, such a sample-size illustration describes the size of a future or hypothetical study under chosen assumptions. It is not observed power and does not replace the actual trial result. The record does not give the resulting sample-size values in the registry record for this analysis.
Planning power is conditional on assumptions about the effect size, variability, allocation, follow-up, and statistical test. It does not guarantee that a study will produce a statistically significant finding, and it does not describe the probability that a particular hypothesis is true after seeing data. The stated planning assumptions should therefore be distinguished from the trial's outcome findings, which are not reported in the registry record.
What can the registry information establish?
The record identifies randomization, single masking, a parallel design, the intervention labels, and the stated endpoint method. These details make it possible to describe the intended comparison. They do not establish whether randomization was implemented as intended, whether masking was maintained, or how missing observations were handled. Those details are not reported in the registry record.
For a complete statistical interpretation, readers would need the outcome definition, analysis population, arm-specific summaries, estimated treatment contrast, uncertainty interval, and analysis details. The registry information does not report those primary-outcome results. Accordingly, statistical method explanations describe how the named methods work in general; they cannot substitute for the missing trial estimates.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 4 outcome measures and 5 analyses, and indicates that the primary outcome includes several categories or time points rather than a single reduced comparison. When multiple outcomes, time points, or comparisons are tested, the chance of at least one apparently unusual result can increase. In general, multiplicity methods can define which comparisons are primary and adjust inference when appropriate. The registry record does not report a multiplicity adjustment, a testing hierarchy, or enough detail to determine how the several categories or time points were handled.
The record states that the primary outcome description used a 1% type I error rate for its planning assumptions. It separately describes a planning illustration using a two-sided significance level of 0.05. These are planning statements; the record does not report the analysis-level threshold used for the posted primary comparison or explain their relationship.
Missing-data handling is not reported in the registry record. The primary-outcome description includes an assumed loss to follow-up of 20% in its planning text, but that assumption does not tell readers how many outcome measurements were missing or how missing values were handled in the analysis. The record does not report imputation, sensitivity analyses, or reasons for missingness.
The analysis population is also not reported in sufficient detail. The registry identifies randomized allocation but does not say whether the primary comparison included all randomized participants, only those who received treatment, or another defined population. Without this information and the outcome counts by group, the effect of exclusions or missing measurements cannot be assessed.
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 |
|---|---|---|---|
| Dual Therapy Adverse Event | 0 | 46 | 0.0% |
| Adverse Event Triple Therapy | 0 | 65 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Dual Therapy Adverse Event | 1 of 46 |
| Adverse Event Triple Therapy | 2 of 65 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Dual Therapy Adverse Event | 39 of 46 |
| Adverse Event Triple Therapy | 49 of 65 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dual Therapy Adverse Event | Adverse Event Triple Therapy |
|---|---|---|---|
| asthenia | Skin and subcutaneous tissue disorders | 24 of 46 | 18 of 65 |
| Nausea | Gastrointestinal disorders | 9 of 46 | 18 of 65 |
| Tinnitus | Ear and labyrinth disorders | 6 of 46 | 10 of 65 |
| Palpitations | Cardiac disorders | 4 of 46 | 5 of 65 |
| Ecchymosis | Blood and lymphatic system disorders | 2 of 46 | 2 of 65 |
The registry lists serious adverse events and deaths separately by therapy group. For dual therapy, 46 participants are listed as at risk, with 0 serious adverse events and 1 death. For triple therapy, 65 participants are listed as at risk, with 0 serious adverse events and 2 deaths. The record does not list any top serious adverse-event terms.
Other adverse events are recorded for 39 of 46 at risk in the dual-therapy group and 49 of 65 at risk in the triple-therapy group. These are counts as registered; no percentages or comparative effect estimates are reported. The entries do not explain event severity beyond the serious-versus-other classification, whether participants could contribute multiple events, or the observation period for each safety category.
Deaths are shown as a separate count, and the record does not clarify how they relate to the serious-adverse-event entries. These figures should therefore be interpreted as registry counts rather than as a complete safety analysis. The record does not report event timing, causal attribution, exposure duration, or statistical comparisons of safety outcomes.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of early treatment regimens for mild COVID-19, with average days of symptoms over 14 days identified as the primary outcome. It also reports selected adverse-event counts. However, the primary outcome's arm-level summaries and inferential results are not reported in the registry record. The direction and magnitude of the primary treatment comparison therefore remain unknown from this information.
The record's statements about a target of 25% modification and its planning assumptions should not be mistaken for observed findings. A design assumption is used to plan an analysis; it is not evidence that the corresponding effect occurred. Similarly, a sample-size illustration based on an observed effect is a planning calculation, not observed power. The registry does not report a primary-outcome estimate that would allow readers to judge how the observed data relate to the stated target.
Randomization is a design feature intended, in general, to make treatment groups comparable on average. Whether it achieved that purpose in this trial depends on implementation, follow-up, and analysis details that are not fully reported in the available record. Single masking is recorded, but who was masked and how masking was maintained are not reported.
The adverse-event counts offer limited descriptive information, but they do not establish comparative safety. The record lacks event definitions and timing details needed to interpret the counts fully, and it does not report a statistical comparison. Neither these counts nor the study design alone justify a conclusion about treatment benefit or harm.
In short, the registry supports description of the trial's question, design, and some safety counts. It does not contain the primary results needed to estimate the treatment contrast or its precision. No conclusion about whether either regimen changed symptom duration can be drawn from the reported primary-outcome information.
13. Why This Trial Matters Statistically
This trial is statistically notable because it identifies a randomized, parallel-group comparison and a clinically interpretable continuous outcome: average days with symptoms. These features frame a clear kind of estimand, namely a contrast in average symptom duration between assigned regimens over a stated timeframe. Yet the registry record does not report the numerical comparison needed to quantify that estimand.
The distinction between a study objective, a planning assumption, and an observed result is central to clinical-trial interpretation. The description's 25% target and stated planning assumptions concern the design. They do not show what the participants experienced or how the groups differed. Keeping these categories separate prevents assumptions from being read as findings.
The record also illustrates why reporting needs to connect an endpoint definition to its analysis. It names the mean, standard deviation, and Student's t test, but does not provide the outcome summaries, estimated contrast, uncertainty, or details about the several categories or time points. Without those elements, the statistical method cannot be independently interpreted and the practical scale of any result cannot be assessed.
For biostatisticians and clinical researchers, the key lesson is that a design label and an analysis-method label are not substitutes for complete results reporting. Group-level estimates, a measure of precision, a clearly defined analysis population, and an account of missing data are needed to make the primary comparison interpretable. Their absence limits what can be learned from this registry record, regardless of the trial's completed status.
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 main limitation for interpreting this trial from the registry record is that the primary-outcome results are not reported. Group means, standard deviations, the estimated difference, confidence interval, and p-value are absent. The outcome information also refers to several categories or time points without resolving them into one comparison, leaving the precise reported endpoint structure unclear.
Important design and analysis details are missing. Although the record identifies randomization and single masking, it does not describe sequence generation, allocation concealment, or who was masked. It does not report group allocation counts for the primary analysis, the analysis population, missing-outcome handling, or sensitivity analyses. These omissions prevent assessment of how the stated design translated into the analyzed comparison.
The intervention descriptions are incomplete: both end before giving a full regimen. The follow-up description mentions 14 days followed by video call, but the record does not provide further details about the schedule or completeness of follow-up. The planning text also ends after stating that 62 patients was calculated and adding “however due”; the reason for the qualification is not reported in the registry record.
Safety information is limited to counts, without event definitions, timing, attribution, or comparative analyses. The record does not provide enough context to interpret the serious-event and death entries as a full safety assessment. These limitations concern what can be learned from the registry information and should not be treated as evidence that unreported procedures or analyses were absent.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment — NCT04673214.
- Registry record last updated 2021-08-16; status last verified 2021-08.
- Results first posted 2021-08-16.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT04673214 is listed as a completed, randomized, single-masked, parallel-group Phase 3 trial sponsored by Gilberto Cruz Arteaga. The registry reports enrollment of 114, a start date of 2020-12-16, and a primary completion date of 2021-02-25.
The trial compared a triple-therapy regimen including Azithromycin, Ivermectin, Ribaroxaban, and Paracetamol with a double-therapy regimen listing Azithromycin, Ribaroxaban, and Paracetamol. The stated primary outcome is average days with COVID-19 symptoms over 14 days, summarized by mean and standard deviation, with Student's t test named for the comparison.
Arm-specific primary results and their precision are not reported in the registry record. The registry lists serious adverse-event and other adverse-event counts by group, along with deaths, but does not provide detailed safety analyses.