This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study of Baricitinib (LY3009104) in Children With COVID-19 (NCT05074420), a na phase 3 study. The primary outcome is Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of Baricitinib.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05074420 |
| Phase | Phase 3 |
| Condition | Covid19, Corona Virus Infection |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Hospitalized pediatric participants with COVID-19, aged 1 year to less than 18 years. The registry record lists an enrollment of 6. The pharmacokinetic population was defined as enrolled participants who received at least one dose and had an evaluable pharmacokinetic sample; the number meeting that definition is not reported in the registry record.
Intervention
Baricitinib, given once daily as an oral suspension. The record describes age-group-based dosing: 4 mg for participants aged 10 to <18 years and up to 2 mg for those aged 1 to <10 years. The treatment-duration detail is incomplete in the registry record.
Comparator
There was no comparator group. The study is listed as single-group, with allocation marked NA and masking marked NONE. Its findings therefore do not provide a like-for-like comparison against another treatment or a control condition.
Primary question
The primary outcome concerns baricitinib pharmacokinetics: area under the concentration-time curve, reported in ng*h/mL. It describes drug exposure over the specified sampling periods. The registry record lists a geometric mean and geometric coefficient of variation as the summary measures, but numerical outcome estimates are not reported in the registry record.
The registry describes the study’s purpose as assessing whether baricitinib is effective and safe in hospitalized pediatric participants with COVID-19 and confirming the dose. The recorded primary outcome is pharmacokinetic, rather than a direct comparison of clinical outcomes between treatment groups. Listed secondary outcomes include progression to respiratory support, death or progression, ordinal-scale improvement, ventilator-free days, and time to recovery. Those outcome titles identify what was assessed, but they do not establish what the results were. With no comparator group and no numerical primary outcome in the registry record, the clinical question cannot be answered as a treatment-versus-control effect estimate from this record.
3. Trial Design
This is a phase 3, multicenter, open-label study of baricitinib in pediatric patients hospitalized with COVID-19. The official title describes participants from 1 year to less than 18 years old. The registry lists a single-group model, no masking, and allocation as NA. The listed enrollment is 6, and the study status is TERMINATED. Its start date is 2021-12-21 and its primary completion date is 2024-09-05. The reason for termination is not reported in the registry record.
Participants received baricitinib once daily as an oral suspension. The arm description gives age-based dosing: 4 mg for participants aged 10 to <18 years and up to 2 mg for participants aged 1 to <10 years. The description of how long treatment was administered ends at “up to”; the intended or actual treatment duration is not reported in the registry record. The record does not describe a concurrent control arm, and the study design does not support a randomized comparison.
The primary outcome is pharmacokinetic: area under the concentration-time curve for baricitinib, summarized using a geometric mean and geometric coefficient of variation. Sampling is specified for Day 1 at 0.25, 0.5, and 2-4 hours post-dose, and for Day 4 at pre-dose, 1, and 6-10 hours post-dose. The secondary outcomes cover clinical status, respiratory support, survival, ventilator-free days, and recovery. The record lists 15 outcome measures, but the numerical results for these measures are not reported in the registry record.
Because the design has a single treated group, observations can describe the participants’ outcomes under the study regimen but cannot isolate a treatment effect from the course of illness, other care, or other influences. Open-label conduct also means masking was not used. No random allocation, control condition, or blinding-based comparison is reported. The registry record does not report the reason for termination, a statistical analysis plan, or a sample-size justification.
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 | Baricitinib QD |
|---|---|
| STARTED | 6 |
| At Least One Dose of Study Drug | 6 |
| COMPLETED | 5 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Baricitinib QD |
|---|---|
| The follow-up visit was not completed | 1 |
Analysis population for the primary outcome, as defined in the registry: PK population consisted of all enrolled participants who received at least one dose of study drug and had evaluable PK sample. Based on the planned analysis, outcomes were analyzed and reported per the treatment regimen, irrespective of each dose level.
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: All enrolled participants.
| Characteristic | Unit | Baricitinib QD |
|---|---|---|
| Participants analysed | 6 | |
| Age, Continuous | Years | 7.7 (SD 5.8) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 1 |
| Region of Enrollment: Brazil | Participants | 2 |
| Region of Enrollment: Mexico | Participants | 1 |
| Region of Enrollment: Spain | Participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of Baricitinib, measured over Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | Nanogram* hours per milliliter (ng*h/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is the area under the concentration-time curve (AUC) of baricitinib, measured in ng*h/mL. AUC represents drug concentration accumulated over time during the sampled period. In general, pharmacokinetic measures such as AUC are used to characterize drug exposure; they can help describe whether exposure differs across dosing regimens or populations when suitable comparisons and analysis plans are available. In this study, the record says that the planned analysis was reported per treatment regimen, irrespective of dose level.
Sampling is listed for Day 1 at 0.25, 0.5, and 2-4 hours after dosing, and for Day 4 at pre-dose, 1, and 6-10 hours after dosing. Those are the recorded sampling times, not a complete description of the analysis method. The primary outcome is summarized using a geometric mean and geometric coefficient of variation. In general, a geometric mean summarizes values on a multiplicative scale, while a geometric coefficient of variation describes relative spread on that scale. Such summaries can be useful for pharmacokinetic data, which may vary proportionally rather than by constant additive amounts.
The numerical AUC estimate and its dispersion are not reported in the registry record. Consequently, the outcome definition and sampling schedule clarify what the investigators intended to measure, but do not show the observed exposure or its precision. The record also does not report a comparison against another treatment or a target exposure range.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a small, single-group study: enrollment was 6, and all participants were assigned to a baricitinib regimen. It does not list a comparator group. The primary outcome is pharmacokinetic, and the record specifies the summary measures and sampling times. However, it does not report a numerical AUC estimate or geometric coefficient of variation. Without those results, the posted record does not allow readers to assess the observed exposure or how variable the pharmacokinetic measurements were.
The study’s stated purpose also mentions safety, effectiveness, and dose confirmation. Those aims should not be confused with reported findings. Outcome titles describe measures that were planned or recorded, but titles alone do not establish the results. Although the registry lists clinical secondary outcomes, their numerical findings are not reported in the registry record. The outcome list includes progression to respiratory support, death or progression, changes on the NIAID Ordinal Scale, ventilator-free days, and time to recovery; no clinical effect estimate can be inferred from those names.
The safety summary records serious adverse events in 1 of 6 participants and other adverse events in 5 of 6 participants. The listed serious adverse event term is pneumonia, with a displayed value of 16.7%. No deaths are recorded. These are descriptive registry counts, not a comparison of event risk between baricitinib and an untreated or alternative-treatment group. The record does not establish that an event was caused by baricitinib, nor does it supply information that would support a causal attribution.
The study status is TERMINATED, but the reason for termination is not reported in the registry record. Termination status alone does not explain why the study ended or what conclusions the sponsor drew. The registry record also lists 0 analyses. This means the available record does not present inferential analysis results that could quantify uncertainty around an outcome or support a treatment comparison.
In general, a confidence interval describes a range of values compatible with data and an analysis method, conveying uncertainty around an estimate. No confidence interval for the primary pharmacokinetic outcome is reported in the registry record. The enrollment and the reported safety counts are therefore best read as a limited descriptive account, not as precise estimates of effects in a broader population. No treatment benefit or lack of benefit can be concluded from the information reported.
The sample-size material is described as a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. That illustration is not the trial’s own design: this study is single-group. The illustration is not observed power, and the registry record does not report a sample-size justification for the study. No numerical planning outputs are available in the record, so they cannot be interpreted as evidence about this trial’s results.
9. Statistical Methods Explained
The registry record identifies the primary outcome as pharmacokinetic AUC and lists a geometric mean and geometric coefficient of variation as the summary measures. It does not report a full statistical analysis plan. The distinction matters: an outcome definition tells readers what was measured, while a statistical plan specifies how observations are processed, summarized, compared, and handled when data are incomplete. The available record describes the endpoint and sampling schedule but does not report the numerical endpoint result or the detailed analysis procedures.
What does AUC represent?
In general, area under a concentration-time curve represents cumulative exposure over the period in which concentrations are measured. A concentration at a single time point is a snapshot; an area-based measure incorporates concentration across time. Interpreting AUC depends on the sampling design and the method used to derive the concentration-time profile. The record lists sampling at Day 1: 0.25, 0.5, and 2-4 hours post-dose; and Day 4: pre-dose, 1, and 6-10 hours post-dose. These timings identify the planned observation windows, but the record does not provide the calculation details or numerical values for the curve.
The endpoint unit is ng*h/mL. Units are important because they identify the scale of the reported quantity and allow an estimate to be interpreted as exposure over time rather than as a concentration at one moment. The record does not include a numerical estimate, so the unit alone cannot convey the magnitude of exposure.
Why use a geometric mean?
In general, a geometric mean is a summary of positive measurements on a multiplicative scale. It can be useful when observations vary in proportional terms, such that a change by a factor is more meaningful than a fixed additive change. It differs from an arithmetic mean, which summarizes values on an additive scale. A geometric mean should be interpreted alongside a measure of dispersion and the analysis population. Here, the record names the geometric mean as the primary summary but does not report its value.
The geometric coefficient of variation describes relative dispersion for measurements summarized on a geometric scale. In general, it helps show how widely individual values vary in relation to the central estimate. It is not an uncertainty interval for the mean and should not be read as a confidence interval. The registry record does not report the coefficient’s value or a confidence interval for the AUC estimate. Therefore, it is not possible to judge the observed spread or precision from the listed endpoint definition.
What can a single-group design estimate?
In general, a single-group study can describe measured outcomes among participants who received the study regimen. It cannot, by itself, separate the regimen’s effects from other factors that influence outcomes. A concurrent comparison group can provide a reference under the same study conditions; this registry record does not list one. The design is described as single-group, with allocation marked NA and masking marked NONE. Thus, no randomized treatment contrast is available from this study record.
The absence of a comparator is especially relevant when interpreting clinical outcomes, since disease course and other care can affect recovery, respiratory support, and survival. A change over time within a treated group does not establish that the treatment caused that change. This is a general limitation of uncontrolled designs, not a claim about any unreported result in this study.
What does the analysis population mean?
The primary outcome description defines the pharmacokinetic population as enrolled participants who received at least one dose and had an evaluable pharmacokinetic sample. It also says that, based on the planned analysis, outcomes were analyzed and reported per treatment regimen, irrespective of each dose level. This population definition clarifies which participants were intended to contribute to the PK summaries, but the number meeting the criteria is not reported in the registry record. The record does not state how participants without evaluable samples were handled or whether any measurements were excluded.
In general, an analysis population should be defined before results are interpreted, because inclusion criteria can affect the estimates. A population limited to participants with evaluable samples may differ from all enrolled participants if some samples are missing or unusable. The record does not report the extent or reasons for missing PK data, nor whether missing values were imputed. No assumptions about such procedures should be made from the population definition alone.
How should the planning illustration be read?
The sample-size material is described as an illustration computed from an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For time-to-event outcomes, the illustrations are described as giving total events; for other outcomes, they are described as participants per arm. These are planning illustrations, not observed trial outcomes and not observed power. They are based on a hypothetical two-arm arrangement, whereas this study is single-group. Their assumptions therefore should not be mistaken for features of this study’s design.
In general, a sample-size calculation expresses how much information a hypothetical study may need under specified assumptions. Its output depends on the effect to detect and the chosen analysis conditions. Planning values do not show that a completed study had adequate power, and they do not establish an effect. The registry record does not report the study’s own sample-size justification or provide its statistical plan. The available information does not support claims about interim analyses, prespecified testing procedures, or the intended handling of multiplicity.
The record lists 15 outcome measures and 0 analyses. Those counts describe what is listed in the registry record; they do not explain how the outcomes were prioritized, whether every measure was analyzed, or whether any adjustments were used. Where several outcomes are considered, multiplicity can increase the chance of at least one apparently notable result under repeated testing. In general, methods such as prespecifying a primary outcome or adjusting inference can address that concern, but the registry record does not report which approach, if any, was used. No such method should be inferred.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 15 outcome measures, including a primary pharmacokinetic outcome and secondary clinical outcomes. It lists 0 analyses. The record does not report a statistical analysis plan that explains how multiple outcomes were handled, whether any secondary outcomes were treated as confirmatory, or whether multiplicity adjustments were applied. The presence of several outcomes does not itself show that a particular adjustment was used.
In general, evaluating many outcomes can increase the chance that at least one result appears notable by chance. Prespecifying an outcome hierarchy or using an adjustment can help control interpretation, but the registry record does not report whether either approach was planned or implemented. No inferential conclusions should be drawn from outcome titles alone.
The PK population is defined as enrolled participants who received at least one dose and had evaluable PK samples. The record does not state how many participants met that definition, whether any samples were missing or unevaluable, or how missing observations were handled. It does not report whether imputation, exclusions, or sensitivity analyses were used. These omissions limit assessment of how complete the endpoint data were and how the analyzed population relates to the enrolled group.
The record’s population definition says outcomes were reported per treatment regimen, irrespective of dose level. It does not provide further details about treatment adherence, protocol deviations, or the handling of participants with incomplete treatment. The specific statistical methods beyond the named summary measures 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 |
|---|---|---|---|
| Baricitinib QD | 1 | 6 | 16.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Baricitinib QD | 0 of 6 |
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 |
|---|---|
| Baricitinib QD | 5 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | Baricitinib QD |
|---|---|---|
| Pneumonia | Infections and infestations | 1 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Baricitinib QD |
|---|---|---|
| Sinus bradycardia | Cardiac disorders | 1 of 6 |
| Diarrhoea | Gastrointestinal disorders | 1 of 6 |
| Lip oedema | Gastrointestinal disorders | 1 of 6 |
| Pneumonia | Infections and infestations | 1 of 6 |
| Pustule | Infections and infestations | 1 of 6 |
| Contusion | Injury, poisoning and procedural complications | 1 of 6 |
| Alanine aminotransferase increased | Investigations | 1 of 6 |
| Hypocalcaemia | Metabolism and nutrition disorders | 1 of 6 |
| Hypokalaemia | Metabolism and nutrition disorders | 1 of 6 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 1 of 6 |
Serious events with the highest arm-level rate: pneumonia (16.7%).
The registry safety summary records serious adverse events in 1 of 6 participants and other adverse events in 5 of 6 participants in the Baricitinib QD group. No deaths are recorded. Pneumonia is the listed top serious adverse event term, with a displayed value of 16.7%. These are descriptive counts and a displayed percentage for the treated group; they are not estimates of excess risk relative to a control group.
The record does not provide a comparison group, so the figures cannot show whether event occurrence differed from what would have happened under another treatment or without the study regimen. An adverse event recorded during a study does not, on its own, establish that the study drug caused it. The registry summary does not report enough detail to assess individual event timing, severity beyond the serious-event classification, outcome, or causal attribution.
The enrollment is 6, so each participant’s experience contributes substantially to the descriptive account. The registry record does not provide a more detailed safety analysis or uncertainty intervals. The counts should therefore be read as a record of reported events in this group, not as precise estimates of safety in a wider population.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a phase 3, multicenter, open-label, single-group study of baricitinib was conducted in hospitalized pediatric participants with COVID-19. It records enrollment of 6, a TERMINATED status, and a primary pharmacokinetic outcome based on AUC. It also gives the specified sampling times, summary measures, age-based dosing description, and a summary of adverse events.
It does not report the numerical AUC estimate or its geometric coefficient of variation. It also does not report numerical results for the listed clinical secondary outcomes in the record. The study’s stated aims include safety, effectiveness, and dose confirmation, but aims are not findings. Without numerical outcome results and a comparator group, the record does not establish whether baricitinib changed clinical outcomes or how exposure related to any clinical response.
The safety counts describe events in the treated group, not a treatment-versus-control difference. They do not show whether an event was caused by baricitinib. The record reports no deaths, but that observation does not by itself characterize the risk of death under treatment or in other populations.
The status TERMINATED does not reveal why the study ended; the reason is not reported in the registry record. Nor does the record explain whether termination affected the planned analyses or completion of outcome reporting. No conclusion about those issues should be inferred from status alone.
In general, an uncontrolled study can provide descriptive information, while a comparative design is needed to estimate how outcomes differ between treatment strategies under specified conditions. This record does not support a causal treatment comparison. It should not be interpreted as evidence that baricitinib does or does not work. Its statistical meaning is constrained by the absent numerical primary result, the lack of a comparator, the limited enrollment, and missing detail on analysis and data completeness.
13. Why This Trial Matters Statistically
This study is statistically notable because its stated objectives span pharmacokinetics, safety, and clinical outcomes, while its primary outcome is a pharmacokinetic measure. AUC and its geometric summaries describe drug exposure; they do not directly estimate a comparative clinical effect. Keeping those questions distinct is essential when interpreting a registry record: exposure information may characterize dosing, but it cannot substitute for a controlled estimate of clinical benefit or harm.
The design also illustrates the limits of a single-group study. With no comparator, observed outcomes cannot be separated from the course of COVID-19 or other influences. Open-label conduct means masking was not used, and the record does not include a randomized contrast. The enrollment of 6 further means that the event counts and any observed measurements describe a limited group. These features constrain both the precision and scope of interpretation.
Finally, the record lists 15 outcomes and 0 analyses, but does not report the numerical primary outcome, a statistical analysis plan, missing-data procedures, or multiplicity handling. This difference between a list of intended measures and an interpretable analysis record matters: outcome names do not tell readers what was observed, how uncertainty was assessed, or which conclusions were prespecified. The registry entry supports a careful description of design and reporting gaps, not a numerical judgment about treatment effects.
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 information reported for this study is limited for several trial-specific reasons. The single-group design has no control condition, so the record cannot support a like-for-like treatment comparison. Allocation is listed as NA and masking as NONE. The open-label design also means participants and study personnel were not described as blinded.
Enrollment was 6, and the registry status is TERMINATED. The reason for termination is not reported in the registry record. The record does not explain whether termination affected recruitment, follow-up, or analysis, so those possibilities cannot be assumed. The treatment-duration description is incomplete and does not state how long participants actually received baricitinib.
The primary outcome is clearly named, and sampling times and summary measures are listed, but the numerical AUC result and dispersion are not reported in the registry record. Numerical results for the listed secondary outcomes are also not included in the record. Although the safety summary gives event counts, it does not provide a comparative safety analysis or enough detail to establish causality.
The PK population is defined, but the number included in that population, the extent of missing or unevaluable samples, and the handling of missing data are not reported. The registry record does not report a full statistical plan, a sample-size justification, multiplicity handling, or interim analyses. These omissions limit evaluation of precision, completeness, and the basis for any intended statistical conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Baricitinib (LY3009104) in Children With COVID-19 — NCT05074420.
- Registry record last updated 2026-08-11; status last verified 2026-07.
- Results first posted 2026-08-11.
- 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
The registry record describes NCT05074420, a phase 3, multicenter, open-label, single-group study of baricitinib in hospitalized pediatric participants with COVID-19. The stated age range is 1 year to less than 18 years, and enrollment is 6. The study status is TERMINATED. Its primary outcome is baricitinib AUC, summarized using a geometric mean and geometric coefficient of variation, with PK sampling specified on Day 1 and Day 4.
The record describes once-daily oral suspension dosing by age group and lists clinical secondary outcomes, but the numerical primary outcome is not reported in the registry record. It records serious adverse events in 1 of 6 participants, other adverse events in 5 of 6, pneumonia as the top serious adverse event term at 16.7%, and no deaths. No comparator group is listed. The reason for termination, statistical analysis plan, sample-size justification, and missing-data procedures are not reported in the registry record.