Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19) (NCT04745351), a randomized phase 3 study. The primary outcome is Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29.

2. Clinical Question

3. Trial Design

This was a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study sponsored by Gilead Sciences. The study enrolled 249 participants and is listed as terminated. The registry record gives a start date of 2021-03-31 and a primary completion date of 2022-04-20; it does not report why the study was terminated.

Participants were assigned to remdesivir or matching placebo, with standard of care continued in both groups. The remdesivir regimen was RDV 200 mg on Day 1 followed by RDV 100 mg from Day 2 up to Day 5. The placebo group received matching placebo on the same schedule. Double masking means the study was designed so that treatment assignment was concealed from participants and relevant study personnel, although the registry record does not describe the masking procedures in detail.

The primary outcome was the percentage of participants with all-cause death or invasive mechanical ventilation through Day 29, with the timeframe beginning on the first dose date. The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug. The primary endpoint results include 163 participants in the remdesivir group and 80 in the placebo group. Those endpoint analysis counts are distinct from the overall enrollment figure; the registry record does not explain their relationship in the posted results.

The registry lists 12 outcome measures and 8 analyses. It posts results for 11 secondary outcomes. The original statistical plan, the reasons for termination, and any sample-size justification for the trial 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: 258 participants were screened.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Full Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.

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 included all participants who were randomized into the study and had received at least 1 dose of study drug.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29, measured over First dose date up to Day 29.

The primary endpoint combines all-cause death and invasive mechanical ventilation through Day 29. It counts participants who experienced either event, rather than treating death and ventilation as separate parts of the primary measure. The registry describes the reported percentages as Kaplan-Meier estimates and gives the timeframe as the first dose date up to Day 29.

A composite endpoint can capture more than one clinically consequential event in a single outcome, and may register an event when either component occurs. The components are not interchangeable, however: death and initiation of invasive mechanical ventilation represent different events. The combined result therefore does not by itself show which component contributed more to the overall outcome. Separate secondary outcomes address mortality and initiation of invasive mechanical ventilation.

The Full Analysis Set consisted of participants randomized into the study who received at least 1 dose of study drug. The registry record does not provide additional details about endpoint adjudication, censoring, or handling of participants with incomplete follow-up. Those details matter when interpreting a time-to-event estimate, but should not be inferred from the endpoint description alone.

7. Results Posted in the Registry

• Remdesivir (RDV): 30.1% (49/163) versus 33.8% (27/80) on control; risk difference -3.7 percentage points (95% CI -16.2 to 8.8), risk ratio 0.89 (0.61–1.31); unadjusted two-proportion z-test p = 0.560.

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.

All-cause Mortality Through Day 29

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Remdesivir (RDV): 25.8% (42/163) versus 30.0% (24/80) on control; risk difference -4.2 percentage points (95% CI -16.3 to 7.8), risk ratio 0.86 (0.56–1.31); unadjusted two-proportion z-test p = 0.486.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Remdesivir (RDV) and the control. The interval gives the range of effects that remain compatible with the data.

Percentage of Participants With Initiation of IMV Through Day 29

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Remdesivir (RDV): 13.5% (22/163) versus 12.5% (10/80) on control; risk difference 1.0 percentage points (95% CI -7.9 to 9.9), risk ratio 1.08 (0.54–2.17); unadjusted two-proportion z-test p = 0.829.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Remdesivir (RDV) and the control. The interval gives the range of effects that remain compatible with the data.

Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Remdesivir (RDV): 57.7% (94/163) versus 63.7% (51/80) on control; risk difference -6.1 percentage points (95% CI -19.1 to 6.9), risk ratio 0.90 (0.73–1.12); unadjusted two-proportion z-test p = 0.364.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Remdesivir (RDV) and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover mortality, invasive mechanical ventilation, recovery, clinical status, and renal replacement therapy. The posted results include estimates for several binary outcomes, while the listed outcome measures also include time-to-event and ordinal-scale outcomes. The overall pattern is mixed rather than consistently favoring one group across all outcomes. That variability is compatible with the primary result's uncertainty and does not resolve it.

Secondary endpoints help describe which events and aspects of clinical course may contribute context to the composite primary outcome. Mortality and invasive mechanical ventilation are components of that composite, while recovery measures and clinical status provide different perspectives. They are not interchangeable with the primary endpoint, and results on one cannot be assumed to determine results on another.

The sponsor-reported analyses for the posted secondary comparisons have confidence intervals that include the null values for their respective measures. The secondary data therefore do not supply a clear, consistent signal that would overturn the interpretation of the primary analysis. The registry lists 11 secondary outcomes with posted results, while the record lists 12 outcome measures overall; why some listed measures do not have posted results is not reported in the registry record.

Multiple secondary tests create a multiplicity concern: the more comparisons considered, the more opportunity there is for an apparently notable result to arise by chance. The registry record does not report a multiplicity adjustment or a hierarchy for interpreting secondary endpoints. Without such information, unadjusted secondary results carry less weight than the designated primary analysis. They are best treated as descriptive and exploratory context, rather than as independent confirmatory evidence.

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

• All-cause Mortality Through Day 29
• Percentage of Participants With Initiation of IMV Through Day 29
• Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29
• Time to Recovery Independent of Further Worsening by Day 29
• Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
• Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
• Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29
• Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29

9. Statistical Interpretation

10. Statistical Methods Explained

Two kinds of comparison appear in the primary results: a sponsor-reported time-to-event analysis and a simple unadjusted recalculation from posted summary statistics. Each answers a related but distinct statistical question.

What does the sponsor-reported hazard ratio describe?

The sponsor reports a log-rank analysis with a hazard ratio of 0.816 and a 95% confidence interval from 0.504 to 1.321. A hazard ratio compares the event rates over follow-up between groups, as represented by the time-to-event analysis. It is not the same quantity as a difference between the percentages of participants with an event by a specified time. A hazard ratio below the null value points toward a lower event hazard in the remdesivir group, while a value above the null points in the opposite direction. The confidence interval includes the null value, so the result is compatible with no difference as well as with effects in either direction.

The log-rank test compares the groups' event-time experience over follow-up. The registry record identifies the method and reports the hazard ratio, confidence interval, and p-value, but does not give further details about model assumptions, censoring, or adjustments. Those details are not reported in the registry record.

What does the recalculated risk difference describe?

The unadjusted recalculation expresses the contrast as a risk difference based on the posted event proportions. Its estimate is -0.037, with a confidence interval from -0.162 to 0.088 and p = 0.56. A risk difference is the difference between the event proportions in the two groups, using the stated group order. Negative values indicate a lower proportion in the remdesivir group; positive values indicate a higher proportion. The interval includes zero, the null value for a risk difference.

This recalculation is not an adjusted model and does not reproduce the sponsor's time-to-event analysis. The primary outcome is described as a Kaplan-Meier estimate, while the recalculation is derived from posted summary proportions. Differences in estimand and method mean the two estimates need not match exactly. They should be read as complementary summaries, not as competing versions of a single calculation.

What do confidence intervals and p-values contribute?

A confidence interval conveys the range of effect estimates reasonably compatible with the data and the method, under the assumptions of that analysis. A wide interval indicates limited precision. A p-value describes how unusual the data would be under a specified null hypothesis and model; it is not the probability that the null hypothesis is true. Neither measure alone establishes whether an effect is important in practice. Interpretation also depends on the outcome, design, precision, and completeness of the record.

For the primary analysis, p = 0.613 is the sponsor-reported log-rank p-value. The recalculated p = 0.56 is unadjusted and accompanies the recalculated risk difference. These p-values arise from different analyses, so they should not be substituted for one another. The registry record does not report whether the original analysis plan included other covariates, sensitivity analyses, or interim analyses.

Why can a composite endpoint need separate component results?

A composite combines events into one outcome and can make the overall endpoint easier to analyze than multiple separate primary outcomes. Its interpretation depends on the components and how frequently they occur. A combined estimate does not show the contribution of each component, so the separate mortality and invasive mechanical ventilation outcomes add useful context. Those secondary comparisons remain distinct analyses and should not be used to redefine the primary result after the fact.

More generally, over-dispersion matters when data vary more than a statistical model expects, because standard errors and confidence intervals can then be misleading if the extra variation is ignored. This is a general statistical point, not a feature identified in the registry's primary analysis. The primary outcome is binary as a reported percentage, and the registry does not report an over-dispersion assessment or a model for that issue.

11. Confidence Intervals and Precision

The sponsor-reported primary hazard ratio is 0.816, with a 95% confidence interval from 0.504 to 1.321. This interval includes the null value for a hazard ratio, meaning that the posted data are compatible with no difference in the event hazard as well as with effects in either direction. Its breadth indicates substantial uncertainty about the size and direction of the relative effect.

The unadjusted recalculated risk difference is -0.037, with a confidence interval from -0.162 to 0.088. For a risk difference, zero is the null value; the interval spans zero and estimates on both sides of it. The interval is therefore consistent with a range of possible group differences, not just the point estimate. It does not establish equivalence, because showing equivalence would require a prespecified margin and an analysis designed for that question. Such a margin is not reported in the registry record.

The arm-level Kaplan-Meier estimates are 30.2% for remdesivir and 33.5% for placebo. These estimates are descriptive, while the reported hazard ratio uses event-time information. The confidence intervals for the sponsor-reported hazard ratio and the recalculated risk difference describe uncertainty on different scales and arise from different methods.

In general, confidence intervals are more informative when read as a range of plausible estimates rather than as a pass-or-fail threshold. Precision depends on the amount and distribution of information available to the analysis. The registry record does not report a confidence interval for each arm's Kaplan-Meier percentage, so the precision of those arm-level estimates cannot be assessed from the posted results alone.

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 sample-size illustrations use the observed effect as a starting point and show planning for 100%, 75%, and 50% of that observed effect. The primary endpoint is a time-to-event outcome, so its planning figures are total numbers of events, using the Schoenfeld method. For other outcomes, the figures are participants per arm. The primary-endpoint values are therefore not per-arm enrollment targets.

The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. The trial's own original design assumptions and sample-size justification are not reported in the registry record, so these planning illustrations should not be read as the original protocol's targets.

The 80% power column represents the planning number of events or participants needed for an analysis to have 80% power under the stated assumptions and effect. The 90% power column gives the corresponding planning number for 90% power. These are design calculations for hypothetical future planning, not a measure of how likely the completed trial was to detect an effect.

Smaller effects require more information to detect under the same planning framework. Accordingly, the illustrations show larger required sample sizes or event totals when planning for a smaller fraction of the observed effect. These figures are not observed power; observed power is not a useful substitute for interpreting the estimated effects and their confidence intervals.

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

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.338; treatment proportion p₁ = 0.301; average p̄ = 0.319.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6592 = 1.2920.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6587 = 0.5543.
4. n = (1.2920 + 0.5543)² / (-0.0369)² = 2,505.4, rounded up to 2,506 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
p0 <- 0.3375                          # control proportion
p1 <- 0.300613496932515                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^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 (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(4745351)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 2,506 (80% power), 3,354 (90% power)
 75% of observed effect: n per arm = 4,489 (80% power), 6,009 (90% power)
 50% of observed effect: n per arm = 10,176 (80% power), 13,622 (90% power)
power.prop.test: 2505.4 
Simulated power at n = 2,506 per arm: 0.804 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-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.

14. Analyses Reported by the Sponsor

The sponsor's primary analysis is a log-rank time-to-event analysis. It reports a hazard ratio of 0.816, a 95% confidence interval from 0.504 to 1.321, and p = 0.613. The posted arm-level Kaplan-Meier estimates are 30.2% for remdesivir and 33.5% for placebo.

The recalculated comparison is an unadjusted risk difference of -0.037, with a confidence interval from -0.162 to 0.088 and p = 0.56. It is calculated from the posted summary proportions and is not a reproduction of the sponsor's time-to-event model. The methods use different summaries, so their point estimates and p-values are not expected to be identical.

The registry record does not flag a discrepancy between the sponsor analysis and the recalculation. The sponsor's analysis is the trial's reported inferential result; the recalculation is a supplementary, unadjusted comparison. Both estimates have intervals that include their respective null values. Neither should be interpreted as proof of no effect or as evidence of equivalence.

The sponsor-reported result takes precedence as the trial's own analysis. The registry record does not report further details of the sponsor's statistical model or a protocol-level analysis plan, so assessment of model specifications beyond the stated log-rank method is not possible from the posted results.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary outcome and lists multiple secondary outcome measures. It reports 8 analyses and posts results for 11 secondary outcomes. The original statistical analysis plan, including any prespecified hierarchy among outcomes or multiplicity adjustment, is not reported in the registry record.

Multiplicity arises when several outcomes or comparisons are tested. When many hypotheses are examined, the chance of at least one apparently unusual result can increase, even if there is no underlying effect. Methods such as adjusting significance thresholds or specifying a testing sequence can address this issue, but the registry record does not establish whether any such approach was planned or used. Consequently, unadjusted secondary p-values should be interpreted cautiously and should not be treated as if each were an isolated confirmatory test.

The registry describes the primary analysis population as the Full Analysis Set: participants randomized and given at least 1 dose of study drug. It does not report additional information about exclusions, protocol deviations, or whether other analysis populations were used for particular outcomes. The endpoint group sizes are 163 for remdesivir and 80 for placebo, while overall enrollment is 249; the record does not explain the difference in the posted results.

Handling of missing outcome data, loss to follow-up, censoring, and sensitivity analyses is not reported in the registry record. These details can affect the interpretation of both binary outcomes and time-to-event analyses. The absence of these details does not establish that the analyses were inappropriate; it means the posted record does not allow readers to assess those choices. Interim analyses and stopping rules are also not reported. The study is listed as terminated, but the reason for termination is not reported in the registry record.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: respiratory failure (12.5%), acute respiratory failure (6.1%), cardiac arrest (4.9%), hypotension (4.3%), cardio-respiratory arrest (3.8%).

The adverse-event results report serious adverse events in 82 of 163 participants at risk in the remdesivir group and 40 of 80 participants at risk in the placebo group. Other adverse events were reported for 60 of 163 and 34 of 80 participants, respectively. The deaths fields list 55 in the remdesivir group and 26 in the placebo group. These are registry counts; they should be read alongside the study's population and follow-up definitions, which are not fully described in the adverse-event summary.

The listed serious adverse event terms include respiratory failure at 12.5%, acute respiratory failure at 6.1%, cardiac arrest at 4.9%, hypotension at 4.3%, cardio-respiratory arrest at 3.8%, and Covid-19 at 3.8%. These terms are event listings, not proof that the study drug caused the events. The registry record does not provide causal attribution or additional detail about how events were assessed in the posted summary.

Counts alone do not establish a comparative safety effect. Interpretation depends on event definitions, exposure, follow-up, severity, and attribution. The safety figures should therefore be read as descriptive registry results rather than as a causal comparison.

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

The primary results describe the frequency and timing of a combined outcome of all-cause death or invasive mechanical ventilation through Day 29 in the two trial groups. The posted Kaplan-Meier estimates are 30.2% for remdesivir and 33.5% for placebo. The sponsor-reported hazard ratio and the unadjusted recalculated risk difference both have confidence intervals that include their null values. These results do not establish a clear between-group difference in the primary outcome.

They also do not show that the treatments are equivalent. A non-significant result is not proof that two groups have the same outcomes. Establishing equivalence or non-inferiority requires a prespecified margin and a design and analysis appropriate to that question; such a margin is not reported in the registry record.

The composite endpoint does not reveal how much each component contributed to the overall result. The separate secondary outcomes provide context, but their analyses are not a substitute for the primary outcome and are subject to multiplicity concerns. The posted findings are estimates with uncertainty, not a definitive explanation of the results.

The record describes a randomized, double-blind, placebo-controlled study and provides results for a Full Analysis Set. Important aspects of interpretation remain unavailable, including the original statistical analysis plan, the reason for termination, and details of missing-data methods. These omissions limit a complete assessment of the analysis and study conduct.

These results apply to the participants and study conditions recorded in this trial: people hospitalized for COVID-19 with severely reduced kidney function, receiving remdesivir or matching placebo alongside standard of care. The results do not by themselves establish what would occur in other populations, settings, or treatment regimens. They are a report of this trial's posted evidence, with the uncertainty and limitations.

18. Why This Trial Matters Statistically

This trial addresses an analysis problem that is statistically important: the primary outcome combines death and invasive mechanical ventilation, while the registry also reports components and other measures of clinical course. A composite can provide a single endpoint for an overall comparison, but the combined estimate needs to be interpreted alongside its distinct components. The posted secondary results provide some context without replacing the primary analysis.

The record also illustrates why the analysis method matters. The sponsor reports a log-rank hazard ratio, which uses event-time information, while the unadjusted recalculation is a risk difference based on summary proportions. These are different estimands and scales. Understanding that distinction prevents treating numerical differences between the estimates as evidence of a reporting inconsistency.

Precision is central to reading the result. The primary confidence intervals include the null values and span estimates in both directions. The data therefore do not support a definitive claim of a difference, but neither do they demonstrate equivalence. The sample-size illustrations show how planning requirements depend on the effect size one aims to detect; they are not the trial's own original design justification.

Finally, the registry's missing details about multiplicity, missing-data handling, and termination reasons matter to statistical interpretation. A transparent record of these choices helps readers assess the reliability and scope of conclusions. The posted results allow a clear account of the primary estimate and its uncertainty, while leaving important questions about the original analysis plan unresolved.

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.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

The study is listed as terminated, but the reason for termination is not reported in the registry record. The record also does not explain the relationship between the overall enrollment of 249 and the primary endpoint group sizes of 163 and 80. This limits assessment of the analysis population relative to the full enrollment.

The original protocol-level statistical plan, sample-size justification, multiplicity strategy, and interim analysis procedures are not reported in the registry record. The planning illustrations use the observed effect and stated assumptions, so they cannot be treated as the trial's original design rationale. The registry does not report the reason for any unposted outcome results among the 12 listed measures.

Details of missing-data handling, censoring, endpoint adjudication, and sensitivity analyses are not reported. The primary outcome is described as a Kaplan-Meier estimate, but the record does not provide enough detail to assess the implementation and assumptions of that analysis. The sponsor's reported log-rank result and the simple unadjusted recalculation also answer related but different statistical questions.

The posted secondary outcomes involve multiple comparisons, and no adjustment or testing hierarchy is reported. This limits the strength of inferences from individual secondary p-values. In addition, the composite endpoint does not identify the relative contribution of death and invasive mechanical ventilation from the primary estimate alone.

The safety summary lists counts and selected event terms, but the registry record does not provide further detail on causality or event-level assessment. These limitations concern what can be concluded from the posted record; they do not establish that unreported methods were absent from the study.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19) — NCT04745351.
• Registry record last updated 2023-05-12; status last verified 2023-04.
• Results first posted 2023-05-12.
• 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

NCT04745351 is a Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study of remdesivir with standard of care versus matching placebo with standard of care in participants hospitalized for COVID-19 with severely reduced kidney function. The registry lists enrollment of 249 and status as terminated.

The primary outcome was all-cause death or invasive mechanical ventilation through Day 29. The sponsor-reported log-rank hazard ratio was 0.816, with a 95% confidence interval from 0.504 to 1.321 and p = 0.613. The interval includes the null value, and the posted results do not establish a clear difference between groups.

The registry does not report the reason for termination, the original statistical plan, or details of missing-data handling and multiplicity procedures. The secondary and safety results add context but require cautious interpretation.