A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection (NCT02532283), a randomized phase 2 study. The primary outcome is Maximum Observed Plasma Concentration (Cmax) of Pimodivir.

2. Clinical Question

The registry identifies the primary outcome as maximum observed plasma concentration (Cmax), measured in nanograms per milliliter. The posted means are 5933.0 for elderly adults and 5378.0 for non-elderly adults. The reported mean difference, oriented as non-elderly adults relative to elderly adults, is -555.0, with a confidence interval from -3370.0 to 2260.0. The interval is wide and includes values on either side of no mean difference, so the point estimate alone should not be treated as a precise estimate of an age-group contrast.

This question is narrower than whether adding JNJ-63623872 to oseltamivir changes influenza outcomes. The primary endpoint describes plasma drug concentration by age, while the listed secondary outcomes include viral measures, complications, patient-reported symptoms, vital signs, and adverse events. Those outcomes require their own results and analyses. The registry record does not report a primary endpoint comparing treatment groups for antiviral activity.

3. Trial Design

This was a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study. It enrolled 102 participants and is recorded as completed. The study concerned adults and elderly hospitalized participants with influenza A infection. The record lists Janssen Research & Development, LLC as the sponsor. The recorded study start was 2015-12-11, and the primary completion date was 2017-02-24.

The treatment descriptions identify two regimens: JNJ-63623872 plus oseltamivir, and placebo plus oseltamivir. Participants in the active-treatment arm were described as receiving JNJ-63623872 600 mg tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. The placebo arm was described as receiving placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Thus, the randomized treatment contrast is the addition of JNJ-63623872 versus placebo on a background of oseltamivir.

The primary outcome, however, is reported by age group rather than by randomized treatment group. The registry gives Cmax values for elderly adults aged 65 to less than or equal to 85 years and non-elderly adults aged 18 to <=64 years. The pharmacokinetic analysis set included participants with enough concentration data to derive at least one pharmacokinetic parameter. For this Cmax result, 15 elderly adults and 20 non-elderly adults were analyzed.

This distinction matters when interpreting the reported comparison. Randomization and masking describe the trial design, but the posted primary Cmax means are an age-group summary. The registry record does not state that age groups were randomized against each other, nor does this endpoint directly estimate the effect of active treatment compared with placebo. The result therefore answers a descriptive pharmacokinetic question across the stated age categories, not a randomized treatment-effect question.

The registry lists 19 outcome measures and 16 posted secondary outcomes. These include treatment-emergent adverse events and serious adverse events, time to influenza A viral negativity, viral-load summaries, complications, FLU-PRO score change, and time to improvement of vital signs. The existence of listed outcomes does not establish that every analysis was performed or that all results were posted. Details of recruitment procedures, stratification, adherence, and the original design assumptions 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: In total, 102 participants were randomized. 3 participants were randomized but not treated due to withdrawal of consent before treatment start. Therefore, the Safety Set, comprising all participants who received at least 1 dose of study drug(s), consisted of 99 participants.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Pharmacokinetic (PK) analysis set included all participants from whom sufficient concentration data were available to facilitate derivation of at least one PK parameter. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure (OM).

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: Safety analysis set was defined as all participants who received at least 1 dose of study drug and analyzed as treated.

6. Primary Endpoint

The registry lists the primary outcome as Maximum Observed Plasma Concentration (Cmax) of Pimodivir, measured over Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3.

Cmax is the maximum observed plasma concentration of the study drug over the stated concentration-sampling schedule. In this study, concentrations were assessed pre-dose and at 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3. The endpoint is reported in nanograms per milliliter, with the mean and standard deviation given for each age group.

Pharmacokinetic measures are used to describe drug exposure. A maximum concentration can help characterize the peak level reached in plasma during the measurement period. Comparing Cmax across age groups can describe whether the observed peak concentrations differ in this study population. The registry states that the planned presentation was by age groups, including adults aged 18 to <=64 years and elderly participants aged 65 to less than or equal to 85 years.

This endpoint is not a direct measure of influenza-virus clearance, symptom improvement, complications, or adverse events. Nor is a difference in Cmax, by itself, evidence that a regimen improves a clinical outcome. Those questions correspond to other outcomes listed in the record and require their own estimates and uncertainty. Interpretation of Cmax also depends on the sampling schedule and the availability of concentration data; the registry’s pharmacokinetic analysis-set definition requires enough data to derive at least one pharmacokinetic parameter.

In general, reporting a group mean alongside a standard deviation describes both the average measured concentration and the variability among analyzed participants. It does not show every participant’s concentration profile or explain the cause of variation. The registry record does not report individual concentration data or additional details about the pharmacokinetic model.

7. Results Posted in the Registry

• Non-elderly Adults (18 to <=64 Years): mean 5,378 versus 5,933 on control; difference -555.00 (95% CI -3,370 to 2,260), standardized effect d = -0.13; z-test p = 0.699.

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: it is a measured plasma concentration, and the registry reports its mean and standard deviation. A mean represents the arithmetic average of the measured values in an analysis group. A standard deviation describes the spread of participant values around that group’s mean. It is not the standard error of the mean and is not itself a confidence interval.

What does the mean difference represent?

The recalculated contrast compares the non-elderly group mean with the elderly group mean. The stated direction is non-elderly minus elderly, giving -555.0 ng/mL. A negative estimate means the non-elderly group’s reported mean is lower under that subtraction order. Reversing the order would reverse the sign, so the direction used to define a contrast is essential to reading it correctly. The group means remain the direct descriptive summaries regardless of contrast direction.

This is an unadjusted recalculation from the posted summary statistics, not a statement that the sponsor used this exact method for its analysis. The registry record does not report details of a sponsor model for this endpoint. The record’s discrepancy indicator is false, so no conflict with a sponsor estimate is flagged. In general, when a registry result and a recalculation conflict, the sponsor’s own analysis takes precedence; that issue is not flagged for this result.

How should the confidence interval be understood?

In general, a confidence interval describes a range of values compatible with the data and the statistical procedure used, under that procedure’s assumptions. It conveys uncertainty around an estimate rather than a range containing a fixed proportion of individual participants’ measurements. For this mean difference, the reported interval is -3370.0 to 2260.0 ng/mL. Because the range includes no difference as well as differences in either direction, it does not establish a clear direction for the age-group contrast. Its breadth also signals limited precision.

The confidence interval is not a guarantee that the true value lies within its endpoints, and it does not establish equivalence. A claim that groups are sufficiently similar would require a prespecified margin and an analysis designed to assess that question; such details are not reported in the registry record. Failure to distinguish a difference from no difference is not the same as demonstrating that the groups are alike.

What does the p-value add?

The unadjusted p-value is 0.699. In general, a p-value measures how unusual data at least as discordant with a specified null model would be if that model and the test assumptions held. It is not a measure of effect size, precision, or clinical importance. The p-value should not be interpreted in isolation, especially when the confidence interval is broad and the endpoint is being considered alongside multiple outcomes.

The record does not report the test used for the sponsor’s primary analysis, model diagnostics, or an adjustment strategy for multiple comparisons. The recalculated p-value is explicitly unadjusted. It therefore should not be described as adjusted for the study’s other outcomes, time points, or possible subgroup analyses. Whether any such adjustment was planned or conducted is not reported in the registry record.

Why can variability matter?

Concentration measurements can vary across participants. When a continuous outcome has more variability than a simple model assumes, the estimated uncertainty can be too small if that extra variation is ignored. In general, over-dispersion means that the observed variation exceeds what a model expects. Appropriate modeling can account for such variation when the data and analysis plan support it. The registry record does not report an over-dispersion assessment or a specialized model, so none should be inferred from the posted means and standard deviations alone.

The displayed group standard deviations, 4427.0 and 3888.0 ng/mL, describe observed spread. They do not diagnose over-dispersion relative to a specified model. They also do not reveal the distribution’s shape, outliers, or within-participant concentration patterns. Those assessments would require information not reported in the registry record.

Who is included in the endpoint analysis?

The stated pharmacokinetic analysis set includes participants with sufficient concentration data to derive at least one pharmacokinetic parameter. For Cmax, the registry reports 15 elderly and 20 non-elderly participants analyzed. These are endpoint-specific analysis counts and should not be assumed to represent every enrolled participant or every randomized participant. The record does not report how many participants lacked usable concentration data, why data were unavailable, or how missing measurements were handled.

The endpoint is specified at pre-dose and 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3. The reported Cmax is the maximum observed concentration over the relevant measurements, rather than a time-averaged exposure measure. The registry also lists other pharmacokinetic and clinical outcomes, but the Cmax summary does not provide their results. The record does not report a detailed analysis plan, sample-size justification, interim analyses, or the original assumptions used to design the trial.

10. Confidence Intervals and Precision

The Cmax mean difference is -555.0 ng/mL, with a confidence interval from -3370.0 to 2260.0 ng/mL. The interval spans values below and above no mean difference. This means the observed estimate is compatible with a range of possible age-group contrasts, including contrasts in either direction. The point estimate should not be interpreted as a precise estimate of the underlying difference.

In general, confidence intervals communicate uncertainty in an estimated quantity. A narrower interval indicates greater precision under the same analysis framework; a wider interval indicates less precision. The interval for this result is broad in relation to the estimated difference, so the data do not tightly locate the age-group contrast. Its width reflects the information available to the recalculation and the observed variability, but the posted summaries do not allow the separate contribution of each factor to be identified.

The interval is not an interval for individual Cmax values, and it does not mean that most participants had concentrations within its endpoints. Individual values may be more dispersed than the uncertainty range for the mean difference. The group standard deviations, 4427.0 for elderly adults and 3888.0 for non-elderly adults, describe within-group variability; the confidence interval describes uncertainty about the contrast between group means.

The interval’s inclusion of no difference does not demonstrate equivalence, nor does it prove there is no age-related difference. Equivalence requires a clinically or scientifically justified margin and a design and analysis directed at testing whether the uncertainty lies within that margin. Such a margin is not reported in the registry record. The interval also does not establish a treatment effect because the primary comparison is between age groups, not between randomized treatment arms.

The unadjusted p-value of 0.699 is consistent with the uncertainty conveyed by the interval, but neither statistic establishes clinical relevance. A more precise estimate would require more informative data or a different analysis justified by the protocol; the registry record does not report such a plan. The result is best read as a descriptive estimate with substantial uncertainty, rather than as evidence of a definitive difference or equivalence.

11. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures translate the observed mean difference into hypothetical sample sizes for future planning. They are not the number of participants actually analyzed in this Cmax comparison. The displayed counts are participants per arm, not total participants or total events. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each row considers detecting the stated fraction of the observed effect.

For the row using 100% of the observed effect, the planning values are 868 participants per arm for 80% power and 1,162 participants per arm for 90% power. For 75% of the observed effect, they are 1,542 participants per arm for 80% power and 2,065 participants per arm for 90% power. For 50% of the observed effect, they are 3,470 participants per arm for 80% power and 4,645 participants per arm for 90% power.

In plain language, 80% power is the planned probability of detecting an effect of the specified size under the stated assumptions, if that effect is present. The 90% column represents a higher planned probability of detection under those same assumptions. A smaller target effect is harder to distinguish from random variation, so planning for a smaller fraction of the observed effect requires more participants per arm. The same principle explains why the 90% planning column is larger than the corresponding 80% column.

The curve expresses the planning relationship between target effect size and required participants: as the target effect becomes smaller, the required sample size rises. These figures are a planning illustration based on the observed effect, not observed power. They do not describe the trial’s actual design target, and the registry’s original design assumptions and sample-size justification are not reported in the registry record.

12. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -555.000; pooled standard deviation σ = 4125.277.
2. n = 2 × (1.96 + 0.842)² × 4125.277² / -555.000² = 867.3, rounded up to 868 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -555                      # observed difference in means
sigma <- 4125.27663718851                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2532283)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 868 (80% power), 1,162 (90% power)
 75% of observed effect: n per arm = 1,542 (80% power), 2,065 (90% power)
 50% of observed effect: n per arm = 3,470 (80% power), 4,645 (90% power)
power.t.test: 868.2 
Simulated power at n = 868 per arm: 0.801 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

13. Multiplicity, Missing Data and Analysis Populations

The registry lists 19 outcome measures and 16 posted secondary outcomes. The secondary outcomes span adverse events, viral negativity, viral load and its decline, viral-load area under the curve, influenza complications, FLU-PRO score change, and time to improvement of vital signs. The primary Cmax outcome also includes sampling at several specified times, while the reported summary is the maximum observed concentration. Considering several outcomes or analyses can increase the chance of a nominally notable result arising by chance if each is tested separately.

The unadjusted p-value of 0.699 is not described as corrected for multiple testing. Whether the sponsor prespecified a hierarchy, used an adjustment procedure, or treated the analyses as exploratory is not reported in the registry record. The record also does not report an analysis plan that identifies which outcomes were confirmatory, how repeated measures were handled, or whether there were interim analyses. No correction or testing strategy should be inferred from the outcome list alone.

The Cmax analysis population is described as participants with sufficient concentration data to derive at least one pharmacokinetic parameter. The endpoint-specific analyzed counts are 15 elderly adults and 20 non-elderly adults. The record does not report the number of missing concentration observations, the reasons for missingness, or the method used to handle incomplete concentration profiles. It is also not reported whether any participants were excluded after randomization or how those exclusions related to treatment assignment.

Because the primary endpoint is reported by age group, the record’s randomized treatment assignment does not itself determine the interpretation of the age-group comparison. The registry does not report whether the primary Cmax comparison was adjusted for randomized treatment or other covariates. The treatment assignment analysis population, an intention-to-treat analysis, and a per-protocol population for this endpoint are not described in the posted result.

These omissions limit assessment of the analysis process and the potential effects of missing data and multiple testing. They do not invalidate the descriptive group means, but they restrict conclusions about confirmatory inference, robustness, and generalizability. The posted result is most safely read as an unadjusted comparison of the stated pharmacokinetic analysis groups, with uncertainty described by its confidence interval.

14. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: neutropenia (2.9%), infective pulmonary exacerbation of cystic fibrosis (2.9%), cerebrovascular accident (2.9%), bladder outlet obstruction (2.9%), cardiac arrest (1.6%).

The registry reports serious adverse events for the treatment groups as counts among participants at risk. In the pimodivir 600 mg plus oseltamivir 75 mg group, 11 of 64 participants were reported with serious adverse events; in the placebo plus oseltamivir 75 mg group, 4 of 35 were reported with serious adverse events. These figures describe the posted groups and should not be conflated with the Cmax analysis counts, which are specific to the pharmacokinetic endpoint.

For other treatment-emergent adverse events, the posted counts are 45 of 64 in the pimodivir plus oseltamivir group and 24 of 35 in the placebo plus oseltamivir group. The registry reports 1 death in the active-treatment group and 0 in the placebo group. These counts alone do not establish that treatment caused an event or death, and they do not account for differences in exposure time, event severity, or participant characteristics.

The serious-event terms listed include neutropenia, infective pulmonary exacerbation of cystic fibrosis, cerebrovascular accident, and bladder outlet obstruction, each reported as 2.9%; cardiac arrest and hypersensitivity are each reported as 1.6%. The registry’s presented percentages and counts should be interpreted as safety reporting, not as a treatment-effect analysis. Attribution, event timing, and comparative statistical analyses are not reported in the registry record.

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

The primary pharmacokinetic result describes measured Cmax in two age groups. The reported means were 5933.0 ng/mL for elderly adults and 5378.0 ng/mL for non-elderly adults. The recalculated difference, defined as non-elderly minus elderly, was -555.0 ng/mL, with a confidence interval from -3370.0 to 2260.0 ng/mL. This provides a point estimate and an indication of its uncertainty, but the interval is broad and does not settle the direction or size of the age-group contrast.

The result does not show that JNJ-63623872 plus oseltamivir is better or worse than placebo plus oseltamivir. The primary endpoint is presented by age group, not as a randomized treatment comparison. Nor does Cmax alone show whether influenza virus was cleared, viral load declined, symptoms improved, complications occurred, or safety differed. Those are separate questions represented by other listed outcomes.

The study’s randomized, double-blind, placebo-controlled design is relevant to the planned treatment comparison, but it should not be used to give the age-group Cmax result a causal interpretation that the posted analysis does not provide. The registry record does not report whether treatment assignment or other participant characteristics were accounted for in this endpoint analysis.

The result also does not establish that concentrations are equivalent across age groups. A confidence interval spanning no difference is not proof of equivalence; an equivalence assessment needs a justified margin and a suitable planned analysis. Those details are not reported in the registry record. Similarly, a nonsignificant-looking result should not be described as proof that no difference exists.

In practical statistical terms, the posted result is a descriptive pharmacokinetic comparison with appreciable uncertainty. It gives information about the analyzed participants and the specified Day 3 sampling schedule. The available registry information does not support a conclusion about clinical benefit, treatment efficacy, or the broader safety profile beyond the reported safety counts and terms.

16. Why This Trial Matters Statistically

This trial illustrates why the endpoint and comparison must be identified before interpreting a numerical result. Although the study was randomized and placebo-controlled, the posted primary outcome is Cmax summarized across age groups. That is different from comparing randomized treatment arms. Confusing those contrasts could turn a pharmacokinetic description into an unsupported treatment-effect claim.

The result also demonstrates the importance of reporting uncertainty alongside group means. The point estimate of -555.0 ng/mL may appear straightforward, but its confidence interval ranges from -3370.0 to 2260.0 ng/mL. The interval makes clear that the estimate is not tightly determined and that the direction of the underlying contrast remains uncertain. The p-value of 0.699 cannot replace this examination of magnitude and precision.

Clinical trials often report multiple outcomes serving different purposes. Here, the registry lists pharmacokinetic, virologic, symptom, complication, vital-sign, and safety outcomes. A concentration measure addresses drug exposure, while viral and clinical outcomes address other aspects of the illness and its course. Keeping those roles separate prevents an exposure result from being mistaken for evidence about clinical outcomes.

The trial also highlights the difference between observed results and planning illustrations. Planning sample sizes based on an observed effect can show how target effect size and desired power relate, but they do not describe the trial’s original design assumptions or its observed power. The registry record does not report the original sample-size justification. Separating these concepts helps avoid treating retrospective planning calculations as evidence about the trial’s design quality or conclusiveness.

Finally, endpoint-specific analysis populations and missing-data methods matter. The Cmax result includes only participants with sufficient concentration data for at least one pharmacokinetic parameter. Without more detail on incomplete data and analysis choices, readers should keep conclusions appropriately bounded to the posted summaries.

17. 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 primary result is a comparison by age group, while the study’s randomized contrast is between JNJ-63623872 plus oseltamivir and placebo plus oseltamivir. The registry record does not report a treatment-arm Cmax estimate in the posted primary result, so the age-group summaries cannot be used to infer the randomized treatment effect. It is also not reported whether treatment assignment was accounted for in the age-group analysis.

The endpoint analysis includes 15 elderly adults and 20 non-elderly adults, under the registry’s pharmacokinetic analysis-set definition. These endpoint-specific counts are smaller than the recorded enrollment of 102. The record does not describe why participants were not included in this endpoint analysis, how many concentration measurements were missing, or whether missingness was related to age, treatment, or measured concentrations.

The mean difference has a broad confidence interval, and the standard deviations indicate substantial within-group spread. Individual data, distributional summaries, and model diagnostics are not reported. Consequently, the effect of outliers, skewness, or other distribution features cannot be assessed from the registry summaries. The registry record also does not report a detailed pharmacokinetic model or sponsor analysis method for this comparison.

Multiplicity procedures, the original sample-size justification, interim analyses, and a detailed statistical analysis plan are not reported in the registry record. These omissions limit assessment of whether the endpoint was treated as confirmatory, how other outcomes were incorporated, and how robust conclusions are to analysis choices. The study’s Phase 2 designation and completion status do not fill in those missing details.

Finally, the Cmax result concerns peak plasma concentration at a specified Day 3 sampling schedule. It does not provide complete concentration-time profiles or establish the relationship between drug exposure and antiviral or clinical outcomes. Interpretations should remain specific to the reported endpoint, population, and analysis.

18. Related Tutorials

19. Related Statistical Calculators

20. Sources

• ClinicalTrials.gov: A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection — NCT02532283.
• Registry record last updated 2020-03-27; status last verified 2020-03.
• Results first posted 2020-03-27.
• 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.

21. Record Summary

The registry describes a completed Phase 2, randomized, double-blind, placebo-controlled, parallel-group study of JNJ-63623872 with oseltamivir in adults hospitalized with influenza A. The recorded enrollment was 102. The primary outcome was maximum observed plasma concentration of pimodivir, reported by age group for the Day 3 sampling schedule.

The Cmax means were 5933.0 ng/mL among 15 elderly adults and 5378.0 ng/mL among 20 non-elderly adults. The unadjusted recalculated mean difference, non-elderly minus elderly, was -555.0 ng/mL, with a confidence interval from -3370.0 to 2260.0 and an unadjusted p-value of 0.699. The estimate is uncertain and is not a randomized treatment comparison.

The record also lists secondary efficacy and safety outcomes. Serious adverse events were reported in 11 of 64 participants in the pimodivir plus oseltamivir group and 4 of 35 in the placebo plus oseltamivir group. Analysis details, missing-data handling, multiplicity procedures, and the trial’s original sample-size assumptions are not reported in the registry record.