This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US (NCT04582266), a registered phase not stated study. The primary outcome is PK Outcome: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) of Remdesivir (RDV) in Arm 1.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04582266 |
| Phase | Phase not stated |
| Condition | COVID-19 |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 54 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Results posted | Yes |
2. Clinical Question
Population
Hospitalized pregnant women and non-pregnant women of childbearing potential with COVID-19 who were receiving remdesivir as part of clinical care. The primary endpoint population was further defined by minimum intensive pharmacokinetic sampling requirements.
Intervention
Intravenous remdesivir, administered and managed by each participant’s treating physician as part of clinical care. The drug was not provided as part of the study.
Comparator
The record distinguishes pregnant participants from non-pregnant participants. This was a non-randomized study, and the groups are not a like-for-like control comparison.
Primary question
What was the geometric mean area under the plasma concentration-time curve for remdesivir in pregnant participants meeting the pharmacokinetic sampling requirements? The registry record describes the endpoint but does not report its numerical estimate or confidence interval.
The study also sought to describe remdesivir pharmacokinetics and safety in the non-pregnant group. Listed secondary outcomes include pharmacokinetic measures in that group, such as area under the concentration-time curve, half-life, and trough concentration of GS-441524. Safety outcomes include renal, hepatic, and hematologic adverse events, grade 3 or higher adverse events, and serious adverse events.
The central statistical question is descriptive: what measurements and adverse-event frequencies were recorded in these clinical-care groups? Because treatment was not assigned randomly and there was no like-for-like control comparison, differences between groups cannot by themselves identify an effect caused by pregnancy or by remdesivir. The registry record describes the study aims, but the numerical primary pharmacokinetic result is not reported in the registry record.
3. Trial Design
This was IMPAACT 2032, a Phase IV prospective, open-label, non-randomized opportunistic study. It enrolled 54 participants according to the registry record. The study concerned hospitalized women with COVID-19 who were receiving intravenous remdesivir as part of clinical care. Their treating physicians provided and managed the drug; it was not posted as part of the study.
The registry separates participants into pregnant women and non-pregnant women of childbearing potential. These groups were observed rather than created by random allocation. The record explicitly cautions that the arms are not a like-for-like control comparison, and allocation is not stated. Consequently, a difference between the groups may reflect differences in their clinical circumstances or other factors, as well as any difference associated with pregnancy. The record does not establish a causal comparison between the groups.
The study’s principal pharmacokinetic endpoint was the geometric mean area under the plasma concentration-time curve for remdesivir in the pregnant group. Intensive pharmacokinetic sampling occurred on the day of the 3rd, 4th, or 5th infusion. The endpoint description specifies a minimum set of samples for inclusion in the primary analysis population. The record also lists pharmacokinetic and safety outcomes for the non-pregnant group, alongside safety outcomes for the pregnant group.
The registry lists a study start date of 2021-03-31, a primary completion date of 2022-04-13, and a status of completed. It identifies the National Institute of Allergy and Infectious Diseases as sponsor. The registry record does not report a randomization procedure, a control-treatment regimen, or a detailed statistical analysis plan. The design is best understood as an observational description of pharmacokinetics and safety during treatment managed in clinical care, not as a randomized trial designed to estimate a treatment effect.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Arm 1 | Arm 2 |
|---|---|---|
| STARTED | 26 | 28 |
| Received RDV | 25 | 28 |
| COMPLETED | 17 | 23 |
| NOT COMPLETED | 9 | 5 |
Reasons for not completing this period:
| Reason | Arm 1 | Arm 2 |
|---|---|---|
| Lost to Follow-up | 7 | 5 |
| Withdrawal by Subject | 1 | 0 |
| Logistical and Personnel Constraints at Time of Infusion | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Arm 1 women who met the following minimum sampling requirements: (1) at least 3 out of 4 of the end of infusion (EOI) through 3 hours post-end-of-infusion (post-EOI) intensive PK samples AND (2) either the 5 hours post-EOI or the 7 hours post-EOI intensive PK sample AND (3) either the pre-dose or 23-hour post-EOI intensive PK sample, had at least two drug concentrations greater than the lower limit of quantification, and had an available RDV AUC measurement.
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: The Baseline Analysis Population included all women who received any amount of RDV.
| Characteristic | Unit | Arm 1 | Arm 2 | Total |
|---|---|---|---|---|
| Participants analysed | 25 | 28 | 53 | |
| Age, Continuous | years | 32.2 (SD 6.4) | 35.3 (SD 7.4) | 33.8 (SD 7.0) |
| Sex: Female, Male: Female | Participants | 25 | 28 | 53 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 12 | 6 | 18 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 12 | 17 | 29 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 5 | 6 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 6 | 16 | 22 |
| Race (NIH/OMB): White | Participants | 10 | 6 | 16 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 7 | 6 | 13 |
| Region of Enrollment: United States | participants | 25 | 28 | 53 |
6. Primary Endpoint
The registry lists the primary outcome as PK Outcome: Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) of Remdesivir (RDV) in Arm 1, measured over At 3rd, 4th, or 5th infusion. Collection timepoints included: pre-dose, end of infusion (EOI), EOI + 0.75 hours, EOI + 1.5 hours, EOI + 3 hours, EOI + 5 hours, EOI + 7 hours, EOI + 23 hours..
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 90% Confidence Interval |
| Unit | h*ng/mL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the geometric mean area under the plasma concentration-time curve (AUC) of remdesivir in the pregnant group, measured in h*ng/mL. AUC summarizes drug concentration over time across the specified sampling interval. In general, pharmacokinetic researchers use it to describe overall systemic exposure, rather than relying on a concentration at a single sampling time.
For this study, intensive sampling was conducted on the day of the 3rd, 4th, or 5th infusion. The listed collection times run from pre-dose through the end of infusion and post-infusion measurements, including a late sample. The endpoint description says AUC was calculated using non-compartmental methods with a linear up-log down trapezoidal rule in Phoenix WinNonlin v 8.3. The primary analysis population was limited to pregnant participants meeting minimum sampling requirements. Those requirements were intended to ensure adequate observed concentration-time information for the pharmacokinetic calculation; the record does not report additional population-handling details.
A geometric mean is a summary on a multiplicative scale and is often used for pharmacokinetic measurements that are analyzed on a log scale. The stated dispersion measure is a 90% confidence interval, which describes statistical uncertainty around the estimated geometric mean under the analysis method. The numerical geometric mean and its interval are not reported in the registry record. Therefore, the endpoint’s definition and calculation are described, but its magnitude and precision cannot be interpreted from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a study intended to characterize remdesivir pharmacokinetics and safety in pregnant and non-pregnant hospitalized women with COVID-19. It identifies the primary measure as geometric mean remdesivir AUC in the pregnant group and specifies a 90% confidence interval as the dispersion measure. However, the numerical primary estimate and interval are not reported in the registry record. Without those values, the degree of observed exposure and the precision of its estimate cannot be assessed from this record.
The record lists safety counts by group. In Arm 1, 7 of 25 participants at risk were affected by a serious adverse event; in Arm 2, 4 of 28 participants at risk were affected. For other adverse events, the listed figures are 15 of 25 in Arm 1 and 15 of 28 in Arm 2. The record lists zero deaths in each group. These are descriptive safety figures. They do not establish that remdesivir caused an event, and they do not support a causal comparison between the groups. The groups were not randomized or described as like-for-like controls.
The registry lists 28 outcome measures and 0 analyses. The existence of listed outcomes does not itself communicate an estimate, uncertainty interval, or statistical test result. In particular, the record does not provide the numerical primary AUC result, a p-value, or a reported between-group treatment-effect estimate. The record also does not report whether any multiplicity adjustment was used. These omissions limit assessment of inferential strength and of how the listed outcomes were handled analytically.
In general, a confidence interval helps distinguish an estimate’s central value from its uncertainty. A narrow interval indicates greater precision than a wide interval, while neither interval width nor the point estimate alone establishes clinical importance. Here the interval’s limits are not reported, so its precision cannot be described. Likewise, the serious-event counts are observations within groups, not estimates of comparative risk adjusted for differences in participant characteristics or clinical context.
The defensible reading is therefore about study scope and recorded observations, rather than proof of a treatment effect. The study used clinical-care treatment in a prospective, open-label, non-randomized design. Its registry record describes how the primary pharmacokinetic measure was calculated and records group-level safety figures, but the missing numerical primary result and absence of a like-for-like control comparison preclude a fuller assessment of the endpoint or causal conclusions.
9. Statistical Methods Explained
Pharmacokinetics describes how drug concentrations change over time. For this study, remdesivir concentrations were sampled around an infusion, and the primary endpoint was AUC. In general, AUC represents the area under a concentration-time curve and summarizes exposure across the observed interval. It differs from a single concentration measurement, which describes the drug level at one particular sampling time and may not capture the overall concentration profile.
The record states that AUC was calculated using non-compartmental methods and the linear up-log down trapezoidal rule. In general, non-compartmental analysis estimates pharmacokinetic quantities from observed concentration-time data without requiring the concentration profile to follow a specified compartment model. The trapezoidal rule approximates the area between observed time points. The stated method uses linear interpolation for rising concentrations and logarithmic interpolation for falling concentrations. The record identifies Phoenix WinNonlin v 8.3 as the software used. The numerical AUC result is not reported in the registry record.
The geometric mean is an appropriate descriptive summary for measurements that are positive and can vary multiplicatively. In general, it is calculated on a logarithmic scale and then expressed back on the original scale. This differs from an arithmetic mean: the geometric mean gives a summary that is naturally interpreted in relation to proportional variation. The registry identifies the endpoint as a geometric mean, but it does not report the endpoint value or the numerical limits of its 90% confidence interval.
What does the 90% confidence interval describe?
In general, a confidence interval communicates uncertainty in an estimated population quantity, given the data and the method used to construct the interval. The point estimate is the central summary; the interval indicates a range of values compatible with the analysis at its stated confidence level. It is not a guarantee that the true value lies within the interval, nor does it measure the spread of individual participants’ observations. Because the interval limits are not reported in the registry record, readers cannot assess its width or the precision of the primary estimate.
Why do the sampling requirements matter?
AUC depends on concentration measurements across time. Missing samples can leave parts of the concentration-time profile less well characterized and can affect the estimate. The primary population was defined by minimum sampling requirements that included measurements around the end of infusion, a later post-infusion sample, and either a pre-dose or late sample. The record describes those criteria, while the population description ends with an incomplete reference to the late sampling time. It does not report how many participants met the criteria or how incomplete sampling was handled beyond the stated inclusion requirements.
In general, restricting a pharmacokinetic analysis to participants with adequate samples can make each included profile more interpretable, but it also means the result pertains to the defined analysis population rather than automatically to every enrolled participant. Whether those with incomplete sampling differed from those included is not reported in the registry record. No imputation method for missing measurements is reported there either.
How should the non-randomized groups be interpreted?
The study is prospective and open-label, but treatment was managed by treating physicians as part of clinical care. The pregnant and non-pregnant groups were not randomized to pregnancy status or to treatment, and the registry cautions that the arms are not a like-for-like control comparison. In general, randomization can balance measured and unmeasured characteristics in expectation; without random allocation, group differences can reflect clinical or participant differences in addition to the characteristic under study. No adjusted comparative analysis is reported in the registry record. The arm-level observations should therefore be read descriptively rather than as an isolated effect of pregnancy or remdesivir.
The record also gives planning assumptions for sample-size illustrations: a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with an effect defined as a stated fraction of the observed effect. For time-to-event outcomes, the illustration uses total events; for other outcomes, it uses participants per arm. These assumptions describe planning illustrations based on an observed effect, not the study’s own design or observed power. The registry record does not report a sample-size justification or the numerical outputs of those illustrations in the information.
Finally, safety outcomes are presented as counts of participants affected among those at risk. In general, such counts describe the frequency observed during the study’s ascertainment period; they do not, on their own, establish causation or account for differences in follow-up or clinical condition. The record does not provide enough detail to evaluate all those considerations or to derive adjusted comparisons. Its listed outcome measures and safety counts should be interpreted within the observational, clinical-care context.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 28 outcome measures and 0 analyses. That combination describes the number of outcomes listed and the number of analyses recorded; it does not establish that no analyses were performed, nor does it show the results of any analysis. The numerical primary AUC estimate and its 90% confidence interval are not reported in the registry record. Numerical results for the other listed pharmacokinetic outcomes are also not reported in the information.
When a study evaluates many outcomes, there can be more opportunities for apparently unusual findings to arise by chance. In general, multiplicity methods may adjust the interpretation or threshold of statistical tests, depending on the analysis plan and the purpose of the outcomes. The registry record does not report whether outcomes were ranked in advance, whether a multiplicity adjustment was used, or how any testing across outcomes was handled. A formal family-wise or false-discovery adjustment therefore cannot be inferred.
The primary endpoint description specifies a pharmacokinetic analysis population based on minimum sampling requirements. It does not report how many participants met those requirements, whether missing samples occurred, or how incomplete profiles outside the stated criteria were addressed. The record does not report use of imputation or another missing-data method. It also does not describe analysis populations for every secondary outcome, or give a detailed accounting of participants included in each analysis.
In general, missingness matters because an analysis of available observations can be misleading if inclusion depends on characteristics related to the outcome. The registry information does not permit assessment of whether missing measurements were random or whether they could have changed the estimated results. These gaps do not prove that the study analysis was inadequate; they mean that the relevant analytic decisions and results are not reported in the registry record. Interpretation should remain limited to the endpoint definitions and recorded counts rather than assumptions about unreported analyses.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Arm 1 | 7 | 25 | 28.0% |
| Arm 2 | 4 | 28 | 14.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm 1 | 0 of 25 |
| Arm 2 | 0 of 28 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Arm 1 | 15 of 25 |
| Arm 2 | 15 of 28 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm 1 | Arm 2 |
|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 2 of 25 | 1 of 28 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 1 of 25 | 1 of 28 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 1 of 25 | 1 of 28 |
| Foetal heart rate deceleration abnormality | Cardiac disorders | 1 of 25 | 0 of 28 |
| Asthenia | General disorders | 1 of 25 | 0 of 28 |
| COVID-19 pneumonia | Infections and infestations | 1 of 25 | 0 of 28 |
| Haemoglobin decreased | Investigations | 0 of 25 | 1 of 28 |
| Foetal death | Pregnancy, puerperium and perinatal conditions | 1 of 25 | 0 of 28 |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | 1 of 25 | 0 of 28 |
| Superimposed pre-eclampsia | Pregnancy, puerperium and perinatal conditions | 1 of 25 | 0 of 28 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm 1 | Arm 2 |
|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 7 of 25 | 2 of 28 |
| Haemoglobin decreased | Investigations | 4 of 25 | 1 of 28 |
| Lymphocyte count decreased | Investigations | 4 of 25 | 1 of 28 |
| COVID-19 pneumonia | Infections and infestations | 3 of 25 | 1 of 28 |
| Blood glucose increased | Investigations | 1 of 25 | 2 of 28 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 0 of 25 | 3 of 28 |
| Hypotension | Vascular disorders | 3 of 25 | 0 of 28 |
| Lymphopenia | Blood and lymphatic system disorders | 0 of 25 | 2 of 28 |
| Abdominal pain upper | Gastrointestinal disorders | 0 of 25 | 2 of 28 |
| Pyrexia | General disorders | 1 of 25 | 1 of 28 |
Serious events with the highest arm-level rate: respiratory failure (8.0%), foetal heart rate deceleration abnormality (4.0%), asthenia (4.0%), covid-19 pneumonia (4.0%), foetal death (4.0%).
The registry lists serious adverse events for the two groups as participants affected among participants at risk. In Arm 1, 7 of 25 were affected; in Arm 2, 4 of 28 were affected. For other adverse events, the listed figures are 15 of 25 in Arm 1 and 15 of 28 in Arm 2. The recorded number of deaths is zero in each group.
These counts describe events recorded in the study groups. They should not be read as evidence that remdesivir caused an event or prevented one. Treatment was administered as clinical care, the study was non-randomized, and the groups were not like-for-like controls. The record does not provide a causal attribution for the listed events or an adjusted comparison that accounts for clinical differences between groups.
The registry also lists serious-event terms and percentages, including respiratory failure at 8.0%, and foetal heart rate deceleration abnormality, asthenia, COVID-19 pneumonia, foetal death, and gestational hypertension at 4.0% each. Those term-level percentages should be read as registry-reported descriptions, not as comparative risks or evidence about cause. The record does not give further context for interpreting these percentages, such as event timing or attribution. A count of participants with an event and a list of event terms also need not represent the same summary.
In general, safety findings depend on how events are defined, collected, and followed. The registry record gives the group-level counts and selected terms, but not every detail needed to judge those processes.
12. What the Result Does, and Does Not, Mean
The study addresses a descriptive pharmacokinetic and safety question in hospitalized pregnant and non-pregnant women receiving remdesivir for COVID-19. Its primary endpoint is clearly named: geometric mean remdesivir AUC in pregnant participants who met minimum intensive sampling requirements. The record also specifies sampling timing, the calculation approach, and a 90% confidence interval as the dispersion measure. These details explain what the endpoint was intended to summarize.
The numerical primary estimate and its confidence interval are not reported in the registry record. As a result, the endpoint’s observed magnitude and statistical precision cannot be described. A definition of an outcome is not itself a result. The record also lists safety counts and selected serious adverse-event terms, which provide descriptive information about what was recorded in each group.
The design places important limits on interpretation. Remdesivir was administered and managed by treating physicians in clinical care, and participants were not randomized. The pregnant and non-pregnant arms are not a like-for-like control comparison. Therefore, group differences cannot be attributed solely to pregnancy status or to remdesivir, and the design does not establish a causal treatment effect. The safety observations also do not establish whether remdesivir caused any particular event.
In general, a pharmacokinetic exposure measure can help characterize how a drug is present in the body over time. That is distinct from demonstrating a clinical benefit or harm. The record does not report clinical efficacy results, a randomized comparison, or a causal estimate. It also does not provide the primary numerical result needed to judge the size or uncertainty of the exposure estimate.
The appropriate conclusion is narrow: the registry describes the study’s design, endpoint methods, and some safety observations, but the information reported does not support a complete statistical interpretation of the primary endpoint or a causal claim. This is a limitation of what is reported in the registry record, not evidence that an unreported result has any particular value.
13. Why This Trial Matters Statistically
This study is statistically relevant because it illustrates how pharmacokinetic questions can be examined in a clinical-care setting when treatment is not assigned by a research protocol. The study prospectively observed hospitalized pregnant and non-pregnant women receiving remdesivir. Its primary endpoint used intensive concentration sampling to estimate AUC, a measure that summarizes drug exposure across time rather than at a single moment.
The endpoint’s sampling requirements make the analysis population important. Pharmacokinetic estimates rely on observed concentrations at specified times, and a profile with insufficient sampling may not support the same calculation. The registry states minimum sampling criteria, which helps define the intended population for the primary estimate. At the same time, the number meeting those criteria and the handling of missing observations are not reported in the registry record. This highlights why an endpoint definition and analysis-population description need to be considered together.
The study also illustrates the distinction between descriptive group comparisons and causal inference. Pregnant and non-pregnant participants provide clinically meaningful groups for describing pharmacokinetic and safety measurements, but they are not randomized control arms. The registry explicitly warns that the groups are not a like-for-like comparison. That matters when reading any difference in outcomes: observed group contrasts can reflect the context of care or other group characteristics, not only pregnancy status.
Finally, the record demonstrates why registered outcomes and reported results are not interchangeable. It lists 28 outcome measures, but the numerical primary pharmacokinetic result is not reported in the registry record. The safety counts can be described, yet they do not replace the absent endpoint estimate and interval. A statistically careful interpretation therefore separates the methods, recorded observations, uncertainty, and causal claims. The record supports discussion of study scope and design, while leaving key quantitative questions unresolved.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary endpoint is described in methodological detail, but its numerical geometric mean AUC and 90% confidence interval are not reported in the registry record. This prevents assessment of the estimate’s magnitude and precision. The record also does not report numerical results for the listed secondary pharmacokinetic measures in the information.
The study was non-randomized and opportunistic, with remdesivir administered and managed by treating physicians as part of clinical care. The registry states that the arms are not a like-for-like control comparison. Differences between pregnant and non-pregnant groups therefore cannot be interpreted as causal effects of pregnancy or treatment. Allocation is not stated, and no adjusted comparative analysis is reported.
The primary pharmacokinetic population depended on minimum sampling requirements. The record does not report how many participants satisfied those criteria or how incomplete sampling was handled beyond the stated criteria. It also does not report details of missing-data methods, analysis populations for every outcome, or the extent of follow-up for safety outcomes. These omissions limit assessment of potential selection and missingness effects.
The record lists 54 enrolled participants, while safety figures use group-specific numbers at risk. Those figures are reported as stated and are not reconciled in the registry information. The record also lists 28 outcome measures and 0 analyses, but does not report a detailed statistical plan, multiplicity handling, or numerical results for the primary endpoint. The sample-size assumptions are described as planning illustrations rather than the study’s own design; a sample-size justification is not reported in the registry record. Together, these limitations constrain conclusions to the design description and recorded safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US — NCT04582266.
- Registry record last updated 2023-06-09; status last verified 2023-05.
- Results first posted 2023-06-09.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT04582266, titled PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US, is listed as a completed Phase IV prospective, open-label, non-randomized opportunistic study sponsored by the National Institute of Allergy and Infectious Diseases. The registry reports enrollment of 54, a start date of 2021-03-31, and a primary completion date of 2022-04-13.
The study described pharmacokinetics and safety among hospitalized pregnant and non-pregnant women with COVID-19 receiving remdesivir as part of clinical care. Its primary endpoint was geometric mean remdesivir AUC in the pregnant group, with a 90% confidence interval. The endpoint calculation and sampling requirements are described, but the numerical estimate and interval are not reported in the registry record.
The registry lists group-level serious and other adverse-event counts, selected serious-event terms, and zero deaths in each group. The arms were not randomized and are not a like-for-like control comparison, so these observations do not establish causal effects. The record lists 28 outcome measures and 0 analyses.