ACTIV-6: COVID-19 Study of Repurposed Medications - Arm C (Fluticasone): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for ACTIV-6: COVID-19 Study of Repurposed Medications - Arm C (Fluticasone) (NCT05736874), a randomized phase 3 study. The primary outcome is Time to Sustained Recovery in Days.

2. Clinical Question

The comparison is framed around time to recovery rather than a single symptom measurement. That makes the timing of the recovery event central to interpretation: participants were followed for up to 28 days, and the posted primary summary is the median time to sustained recovery. The registry also identifies hospitalization, urgent care, emergency room visits, death, clinical progression, and quality of life among secondary outcomes. Those outcomes address other aspects of the illness, but they do not replace the primary question about time to sustained recovery.

3. Trial Design

Arm C was part of ACTIV-6, a randomized, double-masked, parallel-group Phase 3 study of repurposed medications for non-hospitalized participants with mild to moderate COVID-19. The registry lists fluticasone and placebo as the two interventions in this arm. Enrollment is listed as 1407. The posted primary outcome results give a group size of 656 for fluticasone and 621 for placebo; these are the group denominators associated with that outcome.

The registry record gives a study start date of 2021-08-06, a primary completion date of 2022-03-17, and a status of completed. The record describes the intended study conduct as remote, with in-person visits only if the study team judged one to be in a participant’s best interest. Participants were to self-report new or worsening symptoms and medical events while taking the study drug or placebo.

The fluticasone regimen was a self-administered inhaled dose of 200 µg once daily for 14 days. The placebo arm used a self-administered inhaled placebo once daily for 14 days. The record identifies the trial as randomized, double-masked, and parallel-group, but does not report the randomization procedure, allocation concealment details, or the specific masking procedures.

The registry notes that the protocol was originally registered under NCT04885530 and that a separate record for Arm C was created under guidance for reporting master protocol research programs. It lists Susanna Naggie, MD, as the sponsor. Further details about how this arm was integrated with other medication arms 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.

Overall Study

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: Participants who completed the study.

6. Primary Endpoint

The registry lists the primary outcome as Time to Sustained Recovery in Days, measured over Up to 28 days.

The primary endpoint was time to sustained recovery in days, assessed for up to 28 days. The registry defines recovery as the third of 3 consecutive days without symptoms, measured from receipt of study drug. A participant who died was considered not to have recovered, even if symptom freedom had been reported. The reported group summaries are median survival times, with 95% confidence intervals.

A time-to-event endpoint uses both whether an event occurred and when it occurred. In this trial, the event was sustained recovery. The median gives the time by which half of the group is estimated to have experienced the defined event, under the survival-analysis approach used for the reported summary. Unlike a simple count of recovered participants at one selected day, this approach can retain information about the timing of recovery during follow-up. The registry record does not report the method used to estimate the medians or how participants without a recorded recovery were handled beyond the stated rule for death.

The endpoint is used to describe recovery over time, but it does not by itself describe every aspect of illness burden. Hospitalization, urgent care, emergency room visits, death, clinical progression, and quality of life were listed as secondary outcomes. Their inclusion reflects additional questions about clinical events and participant experience, while the primary endpoint remains focused on the timing of sustained symptom freedom.

7. Results Posted in the Registry

• Arm C - Fluticasone vs Arm C - Placebo: hazard ratio 1.01 (95% CI 0.91–1.12) (as reported in the registry).

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Number of Participants With Hospitalization or Death

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Arm C - Fluticasone: 0.5% (3/656) versus 0.5% (3/621) on control; risk difference -0.0 percentage points (95% CI -0.8 to 0.7), risk ratio 0.95 (0.19–4.67); unadjusted two-proportion z-test p = 0.946.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm C - Fluticasone and the control. The interval gives the range of effects that remain compatible with the data.

Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Arm C - Fluticasone: 3.7% (24/656) versus 2.1% (13/621) on control; risk difference 1.6 percentage points (95% CI -0.3 to 3.4), risk ratio 1.75 (0.90–3.40); unadjusted two-proportion z-test p = 0.096.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm C - Fluticasone and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the assessment beyond recovery timing, including hospitalization and death, urgent care and emergency room visits, clinical progression at specified follow-up points, mortality, and physical function. The registry lists 16 posted secondary outcomes, but detailed numerical results are not reported in the registry record for most of the listed measures in the registry record for this analysis. As a result, an overall numerical synthesis across all secondary outcomes is not possible.

The available hospitalization-related results do not form a single clear pattern. The count for hospitalization or death was the same in the two groups, while the broader composite had more recorded participants in the fluticasone group. The recalculated uncertainty intervals for these comparisons do not establish a clear difference. These outcomes are related to the primary question but are not identical to sustained recovery: they capture clinical events rather than the timing of symptom-free days.

Secondary results should generally carry less weight than the prespecified primary result when many outcomes or analyses are considered. Testing multiple outcomes can increase the chance of at least one apparently unusual result arising by chance. The registry record lists 36 analyses, but does not report whether multiplicity adjustments were made, which analyses were confirmatory, or how secondary findings were prioritized. Accordingly, secondary estimates are best read as supporting or exploratory evidence, not as independent confirmation of a treatment effect.

The primary result and secondary outcomes answer different questions. A near-one primary hazard ratio does not determine the result for every clinical event, and a difference in a secondary endpoint would not by itself overturn the primary comparison. Because many secondary results and their analysis details are not reported in the registry record, conclusions should be limited to the outcomes with posted numerical estimates.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Number of Participants With Hospitalization or Death
• Number of Participants With Mortality
• Time to Mortality
• Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
• Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
• Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
• Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
• Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is a time-to-event measure: the event is sustained recovery, defined in the registry as the third of 3 consecutive days without symptoms. The time origin is receipt of study drug, and the assessment period is up to 28 days. Time-to-event methods are generally useful when an outcome is defined by both occurrence and timing. They can account for participants whose observed follow-up ends before an event is recorded, although the precise approach to censoring and incomplete follow-up is not reported in the registry record.

What does a median time to recovery describe?

A median time is a point on the estimated time-to-event distribution: it represents the time by which half of the group is estimated to have experienced the event. It is not an average recovery time and does not indicate that every participant recovered at that time. In this study, death was specifically treated as non-recovery. The registry reports the median as 12 days for fluticasone and 13 days for placebo, each with a 95% confidence interval. Those summaries give a compact description of timing, but they do not show the full distribution of recovery times.

How should the hazard ratio be read?

The registry reports a hazard ratio of 1.01 for fluticasone versus placebo, with a 95% confidence interval from 0.91 to 1.12. In general, a hazard ratio compares the event rates between groups over the observed time, expressed as a ratio. A value of 1 corresponds to equal rates on that scale; values on either side indicate different relative rates, subject to which group and event are used as the reference. Because the registry record does not report the analysis method, event coding, or direction convention in more detail, interpretation should stay close to the reported estimate and interval. The method used to produce the sponsor’s hazard ratio is not reported in the registry record.

A hazard ratio is not a ratio of median times, nor does it directly state how many days earlier or later recovery occurred. The group medians and the hazard ratio are complementary summaries: the medians describe a selected point in each group’s time-to-event distribution, while the hazard ratio summarizes a relative event-rate comparison. Neither summary alone reveals the entire shape of the recovery curves.

What does a confidence interval add?

A confidence interval communicates uncertainty around an estimate. In general, a 95% confidence interval is generated by a procedure that, over repeated comparable studies, would capture the underlying parameter at the stated rate if its assumptions hold. It is not a range containing a known proportion of individual participant outcomes, and it does not assign a probability to the fixed parameter after the data have been observed. For the primary hazard ratio, the interval includes 1, so the posted estimate does not precisely separate the groups on that relative scale.

What do the secondary-outcome calculations represent?

For binary outcomes, a risk difference expresses the difference between the proportions with an event in the compared groups. The recalculated risk difference for hospitalization, urgent care, emergency room visit, or death is 0.016, with a 95% confidence interval from -0.003 to 0.034. This is a simple unadjusted recalculation from the posted summary counts, not a replacement for the sponsor’s analysis. A confidence interval for a risk difference is compared with zero, the value corresponding to equal risks on that scale. Here the interval extends across zero, indicating substantial uncertainty about the direction and size of the difference.

The recalculated unadjusted p-values for the two secondary binary outcomes are 0.946 for hospitalization or death and 0.096 for the broader composite. A p-value, in general, describes how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the analysis assumptions were correct. It is not the probability that the null hypothesis is true, and it does not measure clinical importance. The registry record does not report p-values for the primary comparison.

Several details needed to fully evaluate the methods are not reported in the registry record: the specific survival-analysis procedure, model covariates, handling of missing symptom reports, analysis population, censoring rules beyond the rule for death, and any planned sensitivity analyses. Without those details, the posted effect estimates can be described, but the complete analysis strategy cannot be reconstructed from the record.

11. Confidence Intervals and Precision

The primary hazard-ratio estimate is 1.01, and its 95% confidence interval ranges from 0.91 to 1.12. The interval includes 1 and allows values below and above that reference. Thus, the point estimate is close to 1, but the interval also indicates uncertainty about the direction and size of the relative difference. It should not be read as proof that the groups have identical recovery patterns.

The median time estimates are 12 days for fluticasone and 13 days for placebo. Their respective 95% confidence intervals are 12 to 13 days and 12 to 14 days. These intervals overlap, and their endpoints show that each median is estimated with some uncertainty. Comparing the intervals visually is not itself a formal test of the difference between medians; the reported hazard ratio is the registry’s stated comparison for the primary time-to-event outcome.

Precision also depends on how many outcome events occur and how variable their timing is, not only on the number of participants enrolled. For the hospitalization-or-death outcome, the recorded event counts are sparse, and the recalculated risk-difference interval extends from -0.008 to 0.007. That interval allows differences in either direction. For the broader hospitalization-related composite, the interval for the recalculated risk difference also includes zero. These intervals are compatible with a range of underlying effects, so the point estimates should not be treated as exact descriptions of the population effect.

Confidence intervals quantify statistical uncertainty under the methods used; they do not address every source of uncertainty. They cannot resolve concerns about unreported analysis choices, missing data, outcome measurement, or generalizability. The registry record does not report enough detail to assess those issues fully. The appropriate reading is therefore that the primary estimate is near the no-relative-difference reference, while the available intervals retain room for effects in either direction.

12. 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 illustrations are based on the observed effect and are not the original trial design calculations. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The assumed effect to detect is expressed as a stated fraction of the observed effect. For time-to-event outcomes, the figures refer to total events; for the other outcomes, they refer to participants per arm.

The 80% power column gives the planning number associated with an 80% chance of detecting the assumed effect under those assumptions, if that effect and the planning model are correct. The 90% power column gives the corresponding planning number for a higher chance of detection under the same assumptions. These are design illustrations, not descriptions of the number enrolled or the number of events observed. For the hospitalization-or-death outcome and the broader composite, the figures are participants per arm. For a time-to-event comparison, they are total events across the groups.

The rows for 100%, 75%, and 50% of the observed effect explore different assumed effect sizes. A smaller assumed effect is harder to distinguish from random variation and therefore requires more participants or events for the same planned power. The visual curve is another way to express how the planned sample size changes with assumptions about the effect; it does not supply evidence about the treatment effect beyond the observed estimate and its uncertainty.

These values are planning illustrations computed from the observed effect, not observed power. The original trial’s sample-size justification and design assumptions are not reported in the registry record. The planning figures should therefore not be used to infer what the investigators originally expected or how likely the completed study was to detect a particular effect.

13. 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

d is the total number of events needed (Schoenfeld's formula) with 1:1 allocation and proportional hazards.

Worked calculation for this trial

1. Hazard ratio HR = 1.010, so ln(HR) = 0.0100.
2. d = 4 × (1.96 + 0.842)² / [ln(1.010)]² = 317,097.4, rounded up to 317,098 events in total 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
hr <- 1.01                              # observed hazard ratio
events_needed <- function(power, frac = 1) ceiling(round(4 * (z_a + qnorm(power))^2 / log(hr^frac)^2, 6))   # Schoenfeld, 1:1 allocation
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: events = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(events_needed(0.80, f), big.mark = ","), format(events_needed(0.90, f), big.mark = ",")))

# Simulation: given d total events under proportional hazards, events in the treatment arm are Binomial(d, hr / (1 + hr)).
# The score (log-rank type) statistic is (D1 - d / 2) / sqrt(d / 4).
set.seed(5736874)
d    <- events_needed(0.80)
reps <- 20000
D1 <- rbinom(reps, d, hr / (1 + hr))
z  <- (D1 - d / 2) / sqrt(d / 4)
cat(sprintf("Simulated power with %s events: %.3f (%d replicates)\n", format(d, big.mark = ","), mean(abs(z) > z_a), reps))

Output from running the code

100% of observed effect: events = 317,098 (80% power), 424,504 (90% power)
 75% of observed effect: events = 563,729 (80% power), 754,673 (90% power)
 50% of observed effect: events = 1,268,390 (80% power), 1,698,014 (90% power)
Simulated power with 317,098 events: 0.802 (20000 replicates)

The simulation uses the fact that, with d events in total and proportional hazards, the number of events in the treatment arm is binomial. It is an approximation that conditions on the total number of events, and it should land close to the target power.

14. Analyses Reported by the Sponsor

For the primary outcome, the sponsor-reported hazard ratio is 1.01, with a 95% confidence interval from 0.91 to 1.12. The posted primary comparison reports the same hazard-ratio estimate and interval. The registry record does not report the method used to produce this analysis, and it does not provide a primary p-value.

For hospitalization or death, the sponsor reports a hazard ratio of 0.94, with a 95% confidence interval from 0.19 to 4.68. The simple unadjusted recalculation instead expresses the comparison as a risk difference. These statistics use different scales and should not be treated as directly interchangeable. The wide sponsor-reported interval is consistent with substantial uncertainty in an outcome with few recorded events.

For the broader hospitalization-related composite, the sponsor reports a hazard ratio of 1.9, with a 95% confidence interval from 0.8 to 3.5. The unadjusted recalculation reports a risk difference and an unadjusted p-value. Differences in the effect measure and method mean the recalculated result is not a substitute for the sponsor’s analysis. The registry record does not report the sponsor’s analysis methods for these secondary comparisons. No discrepancy is flagged between the posted primary summary and the sponsor’s reported primary analysis.

15. Multiplicity, Missing Data and Analysis Populations

The registry record lists 17 outcome measures, including 16 posted secondary outcomes, and 36 analyses. Considering multiple outcomes and analyses matters statistically because the more comparisons examined, the greater the opportunity for a result to appear unusual by chance. This general concern does not mean that any particular result is false; it means that the context and prespecification of analyses are important when interpreting secondary findings.

Whether multiplicity was addressed is not reported in the registry record. The record does not specify a hierarchy among secondary outcomes, a family of comparisons for adjustment, or a correction method. It also does not report which analyses were planned before outcome data were examined. Without these details, the strength of evidence from individual secondary analyses cannot be judged in relation to the full set of analyses.

Missing-data procedures are not reported in the registry record. This matters because the primary outcome relies on symptom reports over time, and incomplete reporting could affect whether and when sustained recovery is recorded. The record states that participants would self-report new or worsening symptoms and medical events, but does not describe how missing symptom entries, withdrawal, or incomplete follow-up were handled in the analysis. The rule that participants who died did not recover is stated; other censoring rules are not.

The analysis population is also not reported in the registry record. The posted group denominators identify the numbers associated with the primary outcome summaries, but do not establish which enrolled participants were included under a specific analysis principle. Randomization, double masking, and parallel-group allocation are recorded, yet further details about allocation procedures and analysis populations are absent. These omissions limit assessment of the full analysis plan and of how robust the posted estimates are to alternative handling of missing observations or other reasonable analytic choices.

16. 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: covid-19 pneumonia aggravated (0.3%), adverse drug reaction (0.2%), coronary vasospasm (0.2%), covid-19 pneumonia (0.2%), diplopia (0.2%).

The registry reports 3 participants with serious adverse events in the fluticasone group and 7 in the placebo group. Other adverse events were reported for 6 participants in the fluticasone group and 9 in the placebo group. Deaths were recorded as 0 in each group. These counts are descriptive; they do not by themselves establish that an event was caused by the assigned inhaled treatment or that the groups differ in safety.

The serious-event terms listed include COVID-19 pneumonia aggravated at 0.3%, adverse drug reaction at 0.2%, coronary vasospasm at 0.2%, COVID-19 pneumonia at 0.2%, diplopia at 0.2%, and nausea and vomiting symptoms at 0.2%. The record does not provide enough detail to infer the timing, clinical course, or attribution of each event. It also does not report a statistical comparison for these safety counts. Such descriptive summaries should be interpreted alongside the study’s follow-up and event-reporting procedures, which are not fully detailed in the registry record.

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

The posted primary result describes a comparison of time to sustained recovery between participants assigned to inhaled fluticasone and those assigned to inhaled placebo. The estimated medians were close, and the reported hazard ratio was near 1. Its confidence interval includes 1 and spans values on either side. The result therefore does not provide a precise estimate that clearly separates the groups on the reported relative scale.

This does not establish that fluticasone and placebo have exactly the same effect. A confidence interval that includes the no-difference reference can reflect a range of possibilities, including modest effects in either direction. Nor does the estimate establish that one treatment is better or worse. The registry record reports statistical summaries, not a definitive clinical conclusion.

The secondary outcomes address different events and experiences, including hospitalization-related events, mortality, clinical progression, and physical function. The available numerical findings for hospitalization-related outcomes are uncertain, while results for most listed secondary outcomes are not reported in the registry record in the registry record for this analysis. Those measures cannot be used to make broader claims about all aspects of illness or recovery.

The reported findings apply to the trial’s recorded Arm C comparison, intervention regimen, population, and follow-up. The record describes non-hospitalized participants with mild to moderate COVID-19 and an inhaled regimen taken once daily for 14 days, with primary follow-up up to 28 days. The registry record does not report enough detail about eligibility, missing data, analysis populations, or methods to determine how the estimates might change under other assumptions. The results should be read as estimates with uncertainty, not as a guarantee about an individual outcome or a recommendation for care.

18. Why This Trial Matters Statistically

This trial illustrates why the definition of an outcome matters. Sustained recovery was not simply a report of feeling better on one day: it required 3 consecutive symptom-free days, and the recorded event date was the third of those days. Death was classified as non-recovery. Such definitions shape what the endpoint measures and how the timing of events is analyzed.

It also illustrates the distinction between a group median and a relative time-to-event comparison. The medians describe estimated recovery timing at a point in each group’s distribution, while the hazard ratio summarizes a relative event-rate comparison over time. Neither measure is interchangeable with a count of participants who experienced a separate clinical event. The reported confidence intervals are essential for understanding how precisely these estimates distinguish the groups.

The secondary outcomes highlight another core statistical issue: an outcome can be clinically important while still being too uncommon in a particular comparison to estimate precisely. Hospitalization-or-death counts were sparse, and the corresponding uncertainty is substantial. That is different from showing that no effect exists. It is a reminder that event counts and study size influence the precision available for each outcome, even when the overall enrollment is larger.

Finally, the record’s multiple outcomes and analyses make transparent reporting of analysis plans important. Without information about multiplicity, missing data, and analysis populations, readers can describe the posted results but cannot fully reconstruct how the complete set of findings was evaluated. This trial therefore provides a useful example of reading effect estimates together with their intervals and the limits of registry-level methodological detail.

19. 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.

Several limitations specific to this trial comparison follow from the information recorded. The primary endpoint depends on self-reported symptoms and requires a sustained symptom-free period. The registry describes self-reporting but does not report the procedures used to verify symptom reports, address missing entries, or establish recovery when reports were incomplete. These details matter for an endpoint defined by a sequence of symptom-free days.

The primary outcome was assessed for up to 28 days. The registry record does not report whether later recovery was assessed or provide the longer-term course of symptoms. The results therefore describe the recorded follow-up window rather than recovery over an unlimited period. The study was intended to be remote, with in-person visits only if the study team considered them appropriate; the record does not describe how remote follow-up completeness was assessed.

Statistical reporting is incomplete for evaluating the analysis in depth. The registry does not report the primary analysis method, hazard-ratio coding details, analysis population, missing-data strategy, or sensitivity analyses. For secondary outcomes, the method behind the sponsor-reported hazard ratios is not reported, and detailed numerical results are not available for most listed secondary measures. Multiplicity handling is also not reported despite the recorded number of analyses.

The sparse hospitalization-related event counts limit precision for those outcomes. The confidence intervals allow a range of differences, and the registry record does not provide a basis for resolving that uncertainty. These limitations do not invalidate the posted estimates, but they constrain how specifically they can be interpreted or generalized beyond the recorded comparison and follow-up.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: ACTIV-6: COVID-19 Study of Repurposed Medications - Arm C (Fluticasone) — NCT05736874.
• Registry record last updated 2023-06-18; status last verified 2023-05.
• Results first posted 2023-04-12.
• 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.

23. Record Summary

The registry record describes a completed, randomized, double-masked, parallel-group Phase 3 comparison of inhaled fluticasone with inhaled placebo in Arm C of ACTIV-6. Enrollment is listed as 1407. The primary outcome was time to sustained recovery, defined as the third of 3 consecutive symptom-free days, with follow-up up to 28 days and death counted as non-recovery.

The median recovery time was 12 days with fluticasone and 13 days with placebo. The reported primary hazard ratio was 1.01, with a 95% confidence interval from 0.91 to 1.12. This estimate is near 1, and its interval includes values on either side of 1. Secondary outcomes included hospitalization-related events, mortality, clinical progression, and physical function. The available secondary results are limited, and the registry record does not report several details needed to reconstruct the full analysis plan.