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 Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 Survivors - Effect of Fenofibrate (NCT05080192), a registered phase not stated study. The primary outcome is Flow Mediated Dilation of the Brachial Artery.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05080192 |
| Phase | Phase not stated |
| Condition | Covid19 |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Pennsylvania |
| Results posted | Yes |
2. Clinical Question
Population
COVID-19 survivors in a sub-study of the FERMIN trial. The registry record lists enrollment of 12, while the arm descriptions refer to approximately 20 subjects in each arm. It does not reconcile these figures or specify how many participants contributed to each endpoint.
Intervention
Fenofibrate administered for 10 days after randomization in the FERMIN trial. The sub-study aims to explore longer-term vascular, cardiac, pulmonary, integrated cardiopulmonary, symptom, and quality-of-life phenotypes.
Comparator
Placebo administered for 10 days after randomization in the FERMIN trial. Although the arm descriptions refer to participants randomized in FERMIN, allocation for this sub-study is not stated in the registry record, so the groups cannot be treated as a confirmed like-for-like randomized comparison.
Primary question
What is the baseline distribution of brachial artery flow-mediated dilation among the participants included in this sub-study? The listed primary measure is an ultrasound-based percentage of brachial artery dilation, used as a measure of endothelial function. The registry record does not report the observed median or inter-quartile range, nor a treatment-group comparison for this endpoint.
3. Trial Design
This completed study is a sub-study associated with the International multicenter FEnofibRate as a Metabolic INtervention for COVID-19 (FERMIN) trial. Its stated purpose is to explore whether fenofibrate is associated with longer-term vascular, cardiac, pulmonary, integrated cardiopulmonary, symptom, and quality-of-life phenotypes among people with COVID-19. The parent trial is described as testing a 10-day intervention on 30-day outcomes; the sub-study focuses on longer-term health measures.
The registry lists University of Pennsylvania as sponsor, enrollment of 12, a start date of 2021-08-11, and primary completion on 2022-05-10. Its status is completed. Fenofibrate and placebo are the listed interventions. The arm descriptions say approximately 20 subjects were randomized to each FERMIN arm and received their assigned drug for 10 days post-randomization. The enrollment figure and approximate arm descriptions do not align on their face; the registry record does not explain the difference or identify the analytic sample for each outcome.
The sub-study’s allocation is not stated in the registry record. Although the arm descriptions refer to randomization in FERMIN, the record flags these arms as not a like-for-like control comparison. Therefore, the group labels alone do not establish a randomized comparison for the sub-study analyses. The listed primary endpoint is measured at the baseline visit, rather than being a reported change from baseline. The record lists seven outcome measures and no analyses.
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
| Stage | Fenofibrate Recipients | Placebo Recipients |
|---|---|---|
| STARTED | 7 | 5 |
| COMPLETED | 7 | 5 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The data for 1 fenofibrate recipient were omitted from analysis due to poor quality. 1 fenofibrate recipient did not undergo the test.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Fenofibrate Recipients | Placebo Recipients | Total |
|---|---|---|---|---|
| Participants analysed | 7 | 5 | 12 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 6 | 5 | 11 |
| Age, Categorical: >=65 years | Participants | 1 | 0 | 1 |
| Age, Continuous | years | 54.29 (SD 10.64) | 40.2 (SD 5.93) | 48.42 (SD 11.28) |
| Sex: Female, Male: Female | Participants | 3 | 3 | 6 |
| Sex: Female, Male: Male | Participants | 4 | 2 | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 0 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 | 5 | 10 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 2 | 5 |
| Race (NIH/OMB): White | Participants | 3 | 3 | 6 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 7 | 5 | 12 |
6. Primary Endpoint
The registry lists the primary outcome as Flow Mediated Dilation of the Brachial Artery, measured over At baseline visit.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | % of brachial artery dilation |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is flow-mediated dilation of the brachial artery, measured by ultrasound and expressed as a percentage of brachial artery dilation. The registry describes it as a metric of endothelial function. Flow-mediated dilation assesses how the artery responds to a change in blood flow; it is used in research as a physiological measure of vascular function. This describes the measure’s general role, not a clinical diagnosis or a direct measure of how a participant feels.
The stated timeframe is the baseline visit. Thus, the primary measure listed in the registry is a baseline value, not a follow-up change or an estimate of a treatment effect over time. The planned summary is the median with an inter-quartile range, a distribution-focused description that reports a central value and the spread of the middle portion of observations. The registry record does not report the median, inter-quartile range, group-specific endpoint values, or a comparison between groups.
The endpoint population description notes that data for one fenofibrate recipient were omitted because of poor quality and that one fenofibrate recipient did not undergo the test. These statements indicate that the test was not usable or available for those participants, but the record does not give the final endpoint sample size or describe how the omissions were handled in any analysis.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a biologically relevant vascular measure and states how it was intended to be summarized, but it does not report the endpoint values. Without group medians, inter-quartile ranges, or an analysis comparing groups, the posted information does not establish the direction, magnitude, or precision of any difference in baseline flow-mediated dilation. There is consequently no reported primary-endpoint estimate from which to judge how compatible the data are with different group differences.
The endpoint is recorded at baseline. A baseline measurement can describe the participants’ vascular phenotype at that visit, but by itself it cannot show whether fenofibrate changed the measure over time. The study description refers to longer-term outcomes as the sub-study’s broader goal, yet the listed primary measure’s timeframe is baseline. A treatment-effect interpretation would require an appropriate follow-up comparison or an analysis of change; neither is reported for this endpoint.
The record also cautions against treating the fenofibrate and placebo groups as a confirmed randomized comparison for this sub-study: allocation is not stated, and the arms are not identified as a like-for-like control comparison. Arm descriptions refer to participants randomized in the FERMIN trial, but the record does not explain how those parent-trial arms correspond to the sub-study population or analytic groups. This uncertainty limits causal interpretation even if group-specific values were available.
Precision cannot be assessed from the listed endpoint information. The registry gives no endpoint sample size, variability estimate, confidence interval, or inferential test result. The overall enrollment is 12, while the arm descriptions refer to approximately 20 subjects in each arm; the record does not reconcile these counts. In addition, data from one fenofibrate recipient were omitted for poor quality and one did not undergo the test. These missing measurements may affect how representative the analyzed endpoint values are, but their effect cannot be assessed without further information.
Accordingly, the posted record supports a description of the study’s objective, measurement, and stated data exclusions, but not a conclusion about a treatment difference. Absence of a reported result is not evidence that the groups were equal, and it is not evidence that one group had a better outcome. The statistical result for the primary endpoint is not reported in the registry record.
9. Statistical Methods Explained
What does the median and inter-quartile range describe?
The registry specifies a median and inter-quartile range for the primary endpoint. The median is the central observation when measurements are ordered. The inter-quartile range describes the spread of the middle portion of the observed values. These summaries are often useful when a distribution is skewed or when extreme observations could make a mean and standard deviation less representative. This is general statistical context; the registry record does not report the endpoint distribution or explain why this summary was selected.
A median and inter-quartile range describe the observed data; they do not, on their own, quantify the uncertainty in a treatment comparison. To estimate a group difference, an analysis would need to define the comparison and report an effect estimate, with an appropriate measure of uncertainty. The registry lists no analysis results, confidence intervals, or p-values for the primary endpoint.
What would a confidence interval add?
In general, a confidence interval gives a range of values compatible with an estimate under the assumptions of the statistical method. It helps readers judge precision as well as the estimated direction and size of an effect. A narrow interval indicates greater precision than a wide interval, while an interval spanning effects in different directions may leave substantial uncertainty about the comparison. These are general principles, not findings from this study: the registry record does not report a confidence interval or a primary-endpoint estimate.
Why do the analysis population and allocation matter?
An analysis population defines which participants’ measurements contribute to a result. For a measurement endpoint, the number with a usable test can differ from enrollment because a test may not be performed or may fail quality checks. The registry notes that data from one fenofibrate recipient were omitted for poor quality and that one fenofibrate recipient did not undergo the test. It does not state the final analytic sample size, whether other measurements were unavailable, or the rules used to determine inclusion.
Allocation also affects interpretation. Random assignment can support a causal comparison when the assigned groups are analyzed appropriately, but the registry does not state allocation for this sub-study and explicitly cautions that the arms are not a like-for-like control comparison. The descriptions of randomization in FERMIN do not, by themselves, resolve how participants were selected or grouped for this sub-study. Any comparison would therefore need to be interpreted in light of this design uncertainty.
How should the planning illustrations be understood?
The sample-size assumptions describe planning illustrations based on an observed effect, not the trial’s own design. They specify a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For time-to-event planning, the stated output is the total number of events using the Schoenfeld approach; other planning outputs are participants per arm. Such calculations illustrate the sample sizes associated with chosen assumptions. They are not observed power and do not show that a study had a particular probability of detecting an effect after the data were collected.
The observed effect and numerical planning outputs are not reported in the registry record. As a result, the assumptions can be described, but the planning implications cannot be independently interpreted from the record. The illustrations also cannot substitute for a prespecified sample-size rationale; that rationale is not reported in the registry record.
What does over-dispersion mean in general?
For count outcomes, over-dispersion means that the observed variability is greater than a model’s assumed variability. If a model fails to account for this, standard errors may be too small and confidence intervals may be too narrow. Researchers may use a different model or adjust the uncertainty estimate when the data support it. This is general statistical context only. The registry record does not report a count-outcome model, an over-dispersion assessment, or an analysis plan for the listed outcomes.
More broadly, a statistical method should match the outcome type, study design, missing-data pattern, and intended estimand. The registry record does not provide sufficient detail to identify the inferential methods used for the primary endpoint or the other outcome measures. It lists seven outcomes and no analyses. Therefore, no model specification, adjustment strategy, or treatment-effect estimate can be attributed to the study from this record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven outcome measures, but does not report the analysis results or a statistical analysis plan. It therefore does not state whether one endpoint was designated as the sole confirmatory outcome, whether other outcomes were exploratory, or whether any adjustment for multiple comparisons was planned. When many outcomes or comparisons are examined, the chance of a seemingly notable result occurring by chance can increase. Statistical approaches to multiplicity can address this, but the appropriate approach depends on the study objectives and analysis plan. No particular approach is reported in the registry record.
Missing endpoint data are specifically noted for the primary measure: data for one fenofibrate recipient were omitted because of poor quality, and one fenofibrate recipient did not undergo the test. The registry does not say whether these are distinct participants, give the final endpoint sample size, describe any missing-data method, or report whether other outcomes had missing observations. It also does not describe sensitivity analyses to assess how missing measurements might affect results.
Analysis populations are not defined in the registry record. There is no reported intention-to-treat, per-protocol, or other population definition for the sub-study endpoint. The record’s enrollment of 12 and arm descriptions of approximately 20 subjects in each arm are not reconciled. These gaps prevent a reader from determining which participants were eligible for each analysis or how omissions were handled. The absence of a reported method should not be taken to mean that no method was used; the analysis details are not reported in the registry record.
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 |
|---|---|---|---|
| Fenofibrate Recipients | 0 | 7 | 0.0% |
| Placebo Recipients | 0 | 5 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Fenofibrate Recipients | 0 of 7 |
| Placebo Recipients | 0 of 5 |
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 |
|---|---|
| Fenofibrate Recipients | 1 of 7 |
| Placebo Recipients | 1 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fenofibrate Recipients | Placebo Recipients |
|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | 1 of 7 | 0 of 5 |
| Arm numbness | General disorders | 0 of 7 | 1 of 5 |
The registry reports serious adverse events for the fenofibrate recipients and placebo recipients separately. There were 0 serious events among 7 at risk in the fenofibrate group and 0 among 5 at risk in the placebo group. The record lists 0 deaths in both groups. For other, non-serious adverse events, it reports 1 affected participant among 7 at risk in the fenofibrate group and 1 among 5 at risk in the placebo group.
These are counts from the registry record, not a formal comparison of risk. The groups are small, and the record does not establish a like-for-like randomized comparison for this sub-study. Zero reported serious events does not show that the risk is absent, and the counts cannot establish whether the groups differ. The record gives no serious adverse event terms and does not report further detail about the non-serious events, their timing, severity, or relationship to treatment. The figures should therefore be read as the events recorded in this registry entry, not as a comprehensive estimate of safety.
12. What the Result Does, and Does Not, Mean
The study addresses a question about longer-term health phenotypes among COVID-19 survivors in a sub-study linked to FERMIN. Its primary endpoint is a baseline ultrasound measure of brachial artery flow-mediated dilation, described as a metric of endothelial function. The record also identifies a 10-day fenofibrate intervention and placebo arm in the parent-trial context, and reports limited adverse-event counts.
What the registry record does not establish is whether fenofibrate changed flow-mediated dilation or any other outcome. The primary measure is listed at baseline, and no median, inter-quartile range, follow-up value, comparison estimate, confidence interval, or p-value is reported. Seven outcomes are listed, but no analysis results are included. The record also does not provide enough information to establish an unbiased treatment comparison within this sub-study.
The endpoint’s physiological meaning should not be stretched beyond what it measures. A vascular function metric is not itself a direct measure of symptoms, quality of life, or all aspects of cardiovascular health. The broader research aims include those other domains, but their results are not reported in the registry record. Likewise, the listed adverse-event counts do not establish the overall safety profile of either intervention.
These limits are important when interpreting an absence of results. Missing estimates do not indicate no effect, no difference, or equivalence. They indicate that the posted registry information does not allow the size, direction, or precision of the primary-endpoint comparison to be assessed. The trial’s completion status does not fill that evidence gap; statistical results are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable for the distinction between a research objective and a reported result. The registry describes a sub-study intended to explore a range of longer-term phenotypes, yet its listed primary endpoint is a baseline vascular measure and no endpoint estimate or analysis is reported. A clear endpoint definition is useful, but it cannot replace the values and uncertainty needed to interpret a comparison.
The record also illustrates why design details matter. Arm descriptions refer to randomization in FERMIN, while allocation for the sub-study is not stated and the groups are flagged as not a like-for-like control comparison. Without clarity about how participants entered the sub-study and how the groups were analyzed, a difference between groups, if reported elsewhere, could not automatically be attributed to treatment.
Finally, the enrollment and arm descriptions leave the analyzed population uncertain, and the primary measurement has documented omissions. These features are consequential for precision and representativeness, especially in a small study. The posted record allows readers to identify the intended measurement and some data limitations, but it does not support a quantitative conclusion about treatment effects. That boundary between a defined scientific question and an unreported statistical result is central to responsible interpretation.
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 is that the registry record does not report the primary endpoint result or analysis. It gives no group medians, inter-quartile ranges, effect estimate, uncertainty interval, or inferential test. Although the study is marked completed, completion status does not establish that results are available in this record.
The record lists enrollment of 12 but describes approximately 20 subjects in each arm. It does not explain the difference, specify the number included in the sub-study, or report the endpoint sample size. For the primary measure, data for one fenofibrate recipient were omitted for poor quality and one fenofibrate recipient did not undergo the test; the record does not explain the full missing-data process or its analytic consequences.
There is also uncertainty about the comparison. The arm descriptions refer to randomization in FERMIN, but allocation for this sub-study is not stated, and the registry flags the arms as not a like-for-like control comparison. The record does not specify the analysis population, statistical model, multiplicity strategy, or handling of missing data. It also does not report results for the other listed outcomes. These limitations prevent assessment of the size, precision, robustness, and causal interpretation of any treatment difference from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 Survivors - Effect of Fenofibrate — NCT05080192.
- Registry record last updated 2024-06-21; status last verified 2024-06.
- Results first posted 2024-06-21.
- 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
This completed sub-study is linked to the FERMIN trial and explores longer-term health phenotypes among COVID-19 survivors following a 10-day fenofibrate or placebo intervention in the parent-trial context. The registry lists enrollment of 12, seven outcome measures, and no analyses.
The primary endpoint is baseline brachial artery flow-mediated dilation, summarized as a median and inter-quartile range. The record notes two fenofibrate-recipient measurement omissions but does not report endpoint values or a group comparison. It lists 0 serious adverse events in each group, with 1 non-serious event in each group. Allocation for the sub-study is not stated, and the registry cautions that the arms are not a like-for-like control comparison. Statistical results are not reported in the registry record.