Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients (NCT04360551), a randomized phase 2 study. The primary outcome is Maximum Clinical Severity of Disease Since Entry.

2. Clinical Question

The registry describes a randomized, double-blind, placebo-controlled pilot trial and records triple masking. It focuses on people with acute symptomatic COVID-19 and a clinical severity outcome that combines the World Health Organization COVID-19 ordinal scale with finer symptom distinctions within one part of that scale.

The primary outcome is not a single symptom measurement at one visit. It is each participant’s maximum recorded clinical severity after entry during the study period. The registry reports the group medians and interquartile ranges, along with a Wilcoxon (Mann-Whitney) comparison. Those summaries describe the observed severity-score distributions; they do not by themselves establish how participants’ scores changed over time or explain individual clinical courses.

The registry also lists adverse events as a secondary outcome. The record does not report the reason the trial was terminated, the detailed analysis population, or a fuller statistical plan. Consequently, the primary question can be described from the posted outcome and comparison, but the intended interpretation of all analyses and the circumstances of trial termination are not reported in the registry record.

3. Trial Design

This was a phase 2, randomized, parallel-group, triple-masked pilot trial sponsored by the University of Hawaii. The registry lists telmisartan and placebo as the two interventions. The telmisartan arm description specifies 40 mg orally once daily for 21 days; the placebo arm is described as placebo. The record’s official title identifies the study as double-blind, while the masking field records triple masking.

The brief summary describes symptomatic outpatients who tested positive for COVID-19 and says participants would be randomized 1:1. It outlines daily recording of fever, dyspnea, fatigue, blood pressure, and temperature, with visits on day 1, day 4, day 10, and day 21. It also describes collection of oropharyngeal swabs and blood at study visits for safety laboratory work and evaluation of biomarkers. These are features described in the brief summary; the record does not establish how completely each activity was carried out.

The brief summary states an intended enrollment of 40, while the enrollment field records 24. The posted primary outcome lists 12 participants in each arm. The record gives a start date of 2020-07-01, a primary completion date of 2022-04-26, and a status of terminated. The reason for termination is not reported in the registry record.

The trial’s pilot designation and recorded enrollment are relevant context when judging the precision of the results. The registry does not report a sample-size justification or a detailed account of recruitment, withdrawals, or analysis populations. The posted comparison should therefore be read as the result recorded for this trial, without assuming that a particular design rationale or analysis procedure was used beyond what is explicitly stated.

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: No pre-assignment events.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants with acute COVID infection and symptoms

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 Maximum Clinical Severity of Disease Since Entry, measured over maximum clinical severity of disease post entry evaluated over the 21 day clinical study.

The primary endpoint is titled Maximum Clinical Severity of Disease Since Entry. It measures the maximum severity recorded after entry over the 21-day clinical study period. The registry reports a median and interquartile range for each group, rather than a mean and standard deviation.

The outcome is based on the World Health Organization COVID-19 7-point ordinal scale. Its categories distinguish illness severity, including whether a person is hospitalized, needs oxygen or ventilation, or has died. The registry describes a symptom scale to make finer distinctions among participants in the WHO category for people who are not hospitalized but have activity limitations. Fever, breathing, and fatigue are each scored from 0 to 4 points, with a maximum combined symptom score of 12. The modified scale assigns levels 2.0, 2.25, 2.5, and 2.75 according to those symptom scores.

Using the maximum over the study period captures the most severe recorded status rather than only the status at a particular visit. That can be useful when the clinical question concerns whether participants experienced worsening at any point during follow-up. It also means the endpoint compresses a sequence of observations into one value per participant. The registry does not report further detail about how missing daily or visit measurements affected the maximum score.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the median describe?

The median is the middle of an ordered set of observations. For an ordinal outcome, it provides a useful description of the central position without requiring the distances between all score levels to be treated as equal. Here, the recorded median is 2.0 for both telmisartan and placebo. Identical medians do not imply that every participant had the same score, nor do they show that the full distributions are identical.

The interquartile range describes the middle half of the observed values, using lower and upper quartiles. The registry reports 2.0 to 2.0 for telmisartan and 2.0 to 2.25 for placebo. A narrow interquartile range can coexist with observations outside that range. The registry does not provide the individual scores or a wider summary of the distributions in this outcome entry, so the reported quartiles should not be read as the complete range of severity experienced.

Why use a rank-based comparison?

The registry identifies the Wilcoxon (Mann-Whitney) method for comparing the two arms. In general, this rank-based method orders observations and compares how their ranks are distributed between groups. It can be appropriate for outcomes that are ordinal or do not lend themselves to a simple comparison of means. It tests for a distributional difference; it is not strictly a test only of whether medians differ unless additional assumptions about the shape of the distributions are met.

The p-value reported for this comparison is 0.244. In general, a p-value describes how compatible the observed data, or results more extreme under the test, are with the test’s null model. It is not the probability that the null model is true, and it is not a measure of the magnitude of an effect. Interpretation also depends on the analysis plan and context. The registry does not report a detailed statistical analysis plan, a confidence interval for this comparison, or additional details about how the test was implemented.

Why are confidence intervals useful?

In general, a confidence interval gives a range of values compatible with a data-based estimate under the method used. It helps readers judge precision as well as direction and magnitude. The primary outcome entry reports group medians, interquartile ranges, and a p-value, but no interval estimate for the between-group comparison. As a result, the posted primary result does not directly show the range of contrasts that would be compatible with the data under a specified method.

What does over-dispersion mean?

In general, over-dispersion occurs when observed variability is greater than a statistical model expects. It matters because a model that understates variability can produce uncertainty estimates that are too narrow and tests that appear more decisive than warranted. The registry’s primary outcome is summarized with medians and interquartile ranges and compared with a rank-based method; the record does not report a model-based analysis of this endpoint or an over-dispersion assessment. This general concept should not be mistaken for a finding about this trial.

How should planning illustrations be read?

Any sample-size illustrations associated with the result are planning exercises, not observed trial outcomes and not observed power. The stated assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. Such illustrations show how planning requirements can depend on an assumed effect and method. They do not demonstrate that the trial had a particular probability of detecting an effect, and they are not a substitute for the trial’s own design justification. A sample-size justification is not reported in the registry record.

General statistical principles can clarify what the reported methods do, but they cannot fill in undocumented choices. Details such as any covariate adjustment, handling of ties, prespecified testing threshold, and sensitivity analyses are not reported in the registry record. Conclusions should therefore stay close to the group summaries and the named Wilcoxon (Mann-Whitney) comparison.

10. Analyses Reported by the Sponsor

The registry reports the sponsor’s primary comparison as a Wilcoxon (Mann-Whitney) analysis with p = 0.244. It also posts the group medians and interquartile ranges: 2.0, with a range from 2.0 to 2.0, for telmisartan; and 2.0, with a range from 2.0 to 2.25, for placebo. The sponsor’s reported analysis is the result to use when describing the trial’s own statistical conclusion.

The record does not provide a separate recalculated contrast, confidence interval, or alternative p-value for this endpoint. Thus, there is no posted recalculation to set against the sponsor’s test in this outcome entry. The available summaries can be described directly, but they do not support constructing an unreported effect estimate or uncertainty interval.

Even if a simple re-analysis of summary statistics were possible, it would not reproduce all features of the sponsor’s analysis without the underlying observations and analysis details. The registry does not report the participant-level data, full statistical plan, or enough detail to verify all implementation choices. The sponsor’s own analysis therefore takes precedence over any attempt to infer a new test result from the posted summaries. This does not mean that the p-value establishes equivalence or resolves the question of effect size; the record lacks an interval estimate for that purpose.

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and two analyses, and it identifies one secondary outcome: Number of Adverse Events. The primary outcome is maximum clinical severity since entry. These entries indicate that more than one outcome or analysis appears in the record, but they do not reveal the full set of statistical tests conducted or how the investigators intended to control the chance of false-positive findings across tests.

A multiplicity plan, including any hierarchy of outcomes, adjustment for multiple comparisons, or prespecified testing sequence, is not reported in the registry record. The primary comparison’s p-value should therefore be read as the value posted for that analysis, without assuming that it was adjusted or that it was the only analysis considered. No interim analysis plan is reported in the registry record.

The record posts primary outcome values for the two arms. It also reports adverse-event counts. Another outcome comparison is described as having values missing or not estimable for a two-arm comparison. The registry does not identify further details about which underlying measurements were unavailable or why a comparison could not be estimated.

Details about missing data, withdrawals, exclusions, imputation, and the analysis population are not reported in the registry record. The registry also does not state whether all randomized participants contributed to every endpoint or how incomplete daily records affected the maximum severity outcome. These omissions matter because missingness can affect both the summaries and the group comparison, depending on its extent and pattern.

Without an account of the analysis populations and missing-data procedures, readers cannot determine whether the posted results represent all randomized participants, only those with available measurements, or another defined group. No assumptions about those procedures should be inferred from the reported medians or p-value.

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 non-serious adverse event terms

The registry reports zero serious adverse events affecting participants in each arm and zero deaths in each arm. It reports two participants affected by other adverse events in the telmisartan arm and two in the placebo arm. These are counts as recorded in the registry, not estimates of comparative safety.

The serious-event figures describe the number reported as affected, while the separate other-adverse-event figures cover events classified outside that serious category in the registry entry. They should not be combined into a single count, and the similar other-event counts do not establish that the event types, timing, or severity were alike. The record does not list serious adverse-event terms.

The group sizes recorded for these safety summaries are 12 at risk in each arm. In a pilot trial with these group sizes, the absence of a reported serious event cannot rule out uncommon harms or characterize safety beyond the period and participants captured. The registry does not provide event descriptions, exposure-adjusted rates, detailed follow-up, or a fuller account of collection and adjudication procedures. These figures describe what was posted, not a comprehensive safety assessment.

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

The result describes maximum clinical severity during the 21-day study period among participants in the recorded telmisartan and placebo arms. Both groups have a median score of 2.0. Their interquartile ranges are 2.0 to 2.0 and 2.0 to 2.25, respectively. The registry’s Wilcoxon (Mann-Whitney) comparison reports p = 0.244. Together, these are the available numerical results for the primary outcome and its stated comparison.

These results do not establish that the treatments are equivalent. The registry does not report an equivalence or non-inferiority framework, a margin, or a confidence interval for the between-group comparison. Nor does a p-value of 0.244 prove that there is no difference. It indicates that the posted test did not produce strong evidence of a distributional difference, but the precision and range of plausible differences cannot be judged from a confidence interval because none is reported.

The trial is described as a pilot, and the enrollment field records 24. That context cautions against treating the absence of a clear statistical difference as a definitive answer. The result is also specific to the recorded maximum severity score and study period. It does not by itself settle questions about separate pulmonary or cardiac outcomes, biomarkers, symptom trajectories, or effects beyond the study period.

The registry reports no serious adverse events and no deaths in either arm, with two participants affected by other adverse events in each arm. Those counts do not prove that either intervention is free from risk. They are limited observations from this trial, and the record does not provide detailed event descriptions or longer-term safety information.

Finally, the record’s terminated status is not accompanied by a reason for termination. It is not possible to infer whether that status affected enrollment, follow-up, or analysis. The most defensible reading is a concise one: the posted central severity summaries are close, the recorded rank-based test does not show a clear difference, and the available record leaves substantial uncertainty about precision, missing data, and broader clinical outcomes.

14. Why This Trial Matters Statistically

This trial is statistically informative because it illustrates how a randomized comparison can produce simple-looking group summaries without resolving the size or precision of a possible difference. The median maximum severity score is 2.0 in both arms, but the median alone cannot describe the full distribution. The interquartile ranges add information about the middle spread, and the rank-based test addresses the distributions more broadly than a comparison of medians alone.

The outcome also illustrates a challenge in clinical measurement. It combines an established ordinal severity scale with finer gradations in the activity-limitation category, using symptom scores for fever, breathing, and fatigue. That approach can preserve distinctions that would otherwise be grouped together, but the resulting scale still has ordered categories rather than guaranteed equal intervals. A median and rank-based comparison are consistent with treating the endpoint as ordinal, while readers should keep its construction in mind when interpreting fractional score levels.

The pilot designation, recorded enrollment, and absence of a confidence interval make precision especially important. A p-value alone cannot show whether the data are compatible with a small or a larger difference. Planning illustrations based on fractions of an observed effect are also not evidence of observed power or a replacement for the trial’s own design rationale, which is not reported in the registry record.

The record further shows why transparent reporting matters. The termination reason, missing-data approach, analysis populations, and multiplicity plan are not reported. Those details help readers assess how results arose and how robustly they answer the research question. The posted result is still interpretable within its limits: it provides the outcome summaries and named comparison, while leaving important aspects of design implementation and uncertainty undocumented.

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 does not report why the trial was terminated. Although it records an enrollment of 24 and a primary completion date of 2022-04-26, those details do not explain the circumstances of termination or whether it affected the intended conduct or analysis. The brief summary describes an intended enrollment of 40, but the record does not give a sample-size justification or explain the difference between the stated intention and recorded enrollment.

The primary endpoint compresses severity observations over the 21-day study period into each participant’s maximum. The record does not explain how missing daily records or missed study visits were handled when determining that maximum. It also does not report participant-level values, a confidence interval for the group comparison, or a detailed analysis plan. Consequently, readers cannot independently assess the spread of all scores, the precision of an estimated contrast, or the sensitivity of the result to analytic choices.

Information about the analysis population, exclusions, withdrawals, and missingness is not reported in the registry record. The record also does not describe adjustment for baseline characteristics, handling of multiple outcomes, or interim analyses. No reason for the unavailable or non-estimable two-arm comparison is given beyond the registry’s note that values were missing or not estimable.

Safety information is similarly limited. Counts are posted for serious events, other adverse events, and deaths, but the record does not list serious-event terms or provide fuller descriptions, timing, or a detailed account of adverse-event ascertainment. These omissions restrict interpretation of both the primary outcome and the safety findings, particularly when drawing conclusions beyond this pilot trial and its recorded follow-up.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients — NCT04360551.
• Registry record last updated 2023-08-21; status last verified 2023-08.
• Results first posted 2023-08-21.
• 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.

19. Record Summary

NCT04360551 is a phase 2 randomized, parallel-group pilot trial sponsored by the University of Hawaii. The record describes triple masking and compares telmisartan 40 mg orally once daily for 21 days with placebo in participants with acute symptomatic COVID-19. The brief summary describes an intended enrollment of 40; the enrollment field records 24, with 12 participants in each primary-outcome arm.

The primary outcome is maximum clinical severity since entry over the 21-day study period. Both arms have a median of 2.0; the interquartile ranges are 2.0 to 2.0 for telmisartan and 2.0 to 2.25 for placebo. The posted Wilcoxon (Mann-Whitney) comparison has p = 0.244. The registry reports zero serious adverse events and zero deaths in each arm, and two participants affected by other adverse events in each arm.

The record lists a status of terminated and a primary completion date of 2022-04-26. The reason for termination, confidence interval for the primary comparison, detailed missing-data procedures, and analysis populations are not reported in the registry record.