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 Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19) (NCT04547140), a randomized phase 2 study. The primary outcome is Percentage of Participants Dying or Requiring Intensive Care Unit (ICU) Admission.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04547140 |
| Phase | Phase 2 |
| Condition | COVID-19 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 57 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Grifols Therapeutics LLC |
| Results posted | Yes |
2. Clinical Question
Population
Hospitalized participants with COVID-19. The primary-outcome population is described as the ITT population, including all randomized participants.
Intervention
Liquid alpha1-proteinase inhibitor (human) plus standard medical treatment. The arm description lists intravenous doses of 120 mg/kg on Day 1 and Day 8.
Comparator
Placebo plus standard medical treatment. The placebo was intravenous 0.9% normal saline, with a Day 8 infusion that was not mandatory and was at the principal investigator’s discretion.
Primary question
The registered primary outcome concerns the percentage of participants dying or requiring ICU admission up to Day 29. The brief summary also describes dependence on high-flow oxygen devices or invasive mechanical ventilation on Day 29.
The clinical question is whether adding liquid alpha1-proteinase inhibitor to standard medical treatment changes the occurrence of severe clinical outcomes among hospitalized participants with COVID-19, compared with placebo plus standard medical treatment. The registry record identifies death or ICU admission up to Day 29 as the primary outcome. Its brief summary describes a broader intended question that also includes dependence on high-flow oxygen devices or invasive mechanical ventilation on Day 29. Because the recorded primary-outcome title and the brief summary are not identical in scope, it is important not to assume that every component described in the summary was included in the reported primary endpoint.
The trial was randomized, double-blind, and parallel-group. The listed enrollment was 57. The registry record identifies the primary analysis population as all randomized participants, but does not report the number of participants included in a primary-outcome analysis or the outcome counts by arm. The registry record also does not report the treatment effect estimate or its uncertainty. Therefore, the clinical question can be described from the study design and outcome definitions, but the posted results do not establish how the primary outcome differed between groups.
3. Trial Design
This was a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in hospitalized participants with COVID-19. Participants were assigned to liquid alpha1-proteinase inhibitor plus standard medical treatment or placebo plus standard medical treatment. The registry lists enrollment of 57 and gives the study status as terminated. The reason for termination is not reported in the registry record.
The intervention arm received intravenous liquid alpha1-proteinase inhibitor (human), with the arm description specifying 120 mg/kg on Day 1 and a second 120 mg/kg dose on Day 8. The description of the Day 8 dose is incomplete in the registry record, so additional administration details are not available. The placebo arm received intravenous 0.9% normal saline in a volume matching the active treatment. A Day 8 placebo infusion was not mandatory and was given at the principal investigator’s discretion. Both groups received standard medical treatment.
The listed study start date is 2021-01-29, and the primary completion date is 2021-12-13. Those dates describe the registry timeline; they do not explain why the trial was terminated or how termination affected enrollment, follow-up, or analysis. Those details are not reported in the registry record.
The registry lists secondary outcomes that include changes in National Early Warning Score and ordinal scale, time to a NEWS score of 2 or less maintained for 24 hours, time to hospital discharge, and durations of ICU stay, oxygen use, and mechanical ventilation. These outcomes address different aspects of clinical status and care. Their definitions and analytic results are not all available in the posted results. The registry record lists 15 outcome measures and 13 analyses, but does not provide enough information to reconstruct a complete prespecified analysis plan.
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: 78 participants with Coronavirus Disease 2019 (COVID-19) who were hospitalized were screened of which 57 were randomized in 1:1 ratio to receive either Alpha1-Proteinase Inhibitor (PI) (Human) plus Standard Medical Treatment (SMT) or placebo plus Standard Medical Treatment.
Overall Study
| Stage | Alpha1-Proteinase Inhibitor + Standard Medical Treatment | Placebo + Standard Medical Treatment |
|---|---|---|
| STARTED | 29 | 28 |
| Safety Population | 27 | 27 |
| COMPLETED | 19 | 22 |
| NOT COMPLETED | 10 | 6 |
Reasons for not completing this period:
| Reason | Alpha1-Proteinase Inhibitor + Standard Medical Treatment | Placebo + Standard Medical Treatment |
|---|---|---|
| Adverse Event | 0 | 1 |
| Withdrawal by Subject | 0 | 1 |
| Lost to Follow-up | 3 | 1 |
| Death | 2 | 1 |
| Physician Decision (Does not Include Adverse Events) | 0 | 1 |
| Pregnancy | 1 | 0 |
| Reason Not Specified | 4 | 1 |
Analysis population for the primary outcome, as defined in the registry: ITT population included all participants who were randomized.
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: Intent-to-Treat (ITT) population included all participants who were randomized.
| Characteristic | Unit | Alpha1-Proteinase Inhibitor + Standard Medical Treatment | Placebo + Standard Medical Treatment | Total |
|---|---|---|---|---|
| Participants analysed | 29 | 28 | 57 | |
| Age, Continuous | years | 52.1 (SD 14.46) | 51.2 (SD 12.14) | 51.7 (SD 13.26) |
| Sex: Female, Male: Female | Participants | 14 | 11 | 25 |
| Sex: Female, Male: Male | Participants | 15 | 17 | 32 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 14 | 10 | 24 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 15 | 18 | 33 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Race – White | Participants | 22 | 21 | 43 |
| Race/Ethnicity, Customized: Race – Black or African American | Participants | 1 | 5 | 6 |
| Race/Ethnicity, Customized: Race – Asian | Participants | 3 | 0 | 3 |
| Race/Ethnicity, Customized: Race – American Indian or Alaska Native | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Race – Other | Participants | 2 | 2 | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Dying or Requiring Intensive Care Unit (ICU) Admission, measured over Up to Day 29.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The registered primary endpoint is the percentage of participants dying or requiring intensive care unit admission up to Day 29. It is a binary-outcome summary: each participant is classified according to whether the defined event occurred during the stated period, and the group result is expressed as a percentage. The primary-outcome population is described as the ITT population, which includes all randomized participants.
Combining death and ICU admission can represent a clinically serious outcome that includes both a fatal event and escalation to intensive care. A percentage is useful for describing how often the endpoint occurred in each group. However, the registry record does not report the numbers of participants with the endpoint in either group, the resulting percentages, or a treatment-effect estimate. It also does not describe the endpoint’s detailed operational definitions, such as how ICU admission was counted or handled if a participant had more than one event.
The brief summary describes the study’s intended comparison more broadly: it also refers to dependence on high-flow oxygen devices or invasive mechanical ventilation on Day 29. Those features are not included in the title of the registered primary outcome. The registry record does not clarify whether they formed part of the primary endpoint, were addressed through another outcome measure, or were part of the study’s broader clinical objective. The results cannot be interpreted as an estimate for that broader composite without a corresponding definition and outcome data in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the study question and reports some safety counts, but it does not report a primary-outcome result. In particular, the posted results do not give the number or percentage of participants who died or required ICU admission up to Day 29 in either group. No effect estimate, confidence interval, or p-value for that primary outcome is reported in the registry record. Consequently, the direction, magnitude, and precision of the primary-outcome comparison cannot be assessed from these results.
This distinction matters because a trial’s design and objective are not the same as an observed result. Randomization describes how treatment assignment was intended to occur, while the endpoint describes what was intended to be measured. Neither alone indicates whether the observed outcome differed between groups. The registry lists enrollment of 57, but enrollment does not reveal how many participants experienced the endpoint, how complete the follow-up was, or how the analysis handled participants with missing outcome information.
The brief summary refers to death, ICU admission, and dependence on high-flow oxygen devices or invasive mechanical ventilation on Day 29. The primary-outcome title, by contrast, names death or ICU admission up to Day 29. Without a reported endpoint definition and results for each component or for the combined outcome, it is not possible to tell how those descriptions relate analytically. The posted record therefore does not support a numerical conclusion about the broader set of outcomes in the study summary.
General statistical explanation: an effect estimate describes the observed contrast between groups, while a confidence interval describes the range of values compatible with the data under the analysis assumptions. A narrow interval usually indicates greater precision than a wide interval. Neither an estimate nor its interval is reported for the primary outcome in the registry record, so neither the size of any observed difference nor its precision can be judged.
The safety results report serious adverse events in 5 of 27 participants in each group. They also report other adverse events in 2 of 27 participants in the intervention group and 8 of 27 in the placebo group, and deaths in 2 and 1 participants, respectively. These are descriptive counts, not the primary-outcome comparison. The record does not provide enough detail to determine whether event categories overlap or to make an adjusted comparison. The listed serious adverse-event terms and their percentages should likewise be read as registry-reported safety information, not as proof of a causal treatment effect.
The study status is terminated, but the reason and consequences of termination are not reported in the registry record. It would be speculative to attribute the status to efficacy, safety, recruitment, or any other cause. In the absence of a primary result and an explanation of termination, the appropriate statistical reading is limited: the registry documents a randomized study and some safety counts, but does not permit an estimate of the primary treatment contrast.
9. Statistical Methods Explained
Statistical interpretation depends on separating the study design, the endpoint definition, the analysis population, and the observed results. The registry record identifies a randomized, double-blind, parallel-group design and an ITT primary-outcome population, but does not report a primary-outcome analysis. General explanations of the methods can clarify what those design terms ordinarily mean; they cannot fill in information absent from the registry record.
What does randomization contribute?
In general, randomization assigns participants to study groups using a chance-based process. Its purpose is to reduce systematic differences between groups at assignment, including differences in measured and unmeasured characteristics. It does not guarantee that groups will be identical, especially in a study with limited enrollment. Nor does randomization resolve problems that can arise after assignment, such as missing outcome data, deviations from assigned treatment, or incomplete reporting. The registry identifies randomized allocation but does not report the sequence-generation or concealment procedures.
What does double blinding mean?
In general, masking is intended to limit the influence of treatment knowledge on participant experience, clinical care, outcome assessment, or reporting. The registry lists double masking. It does not identify which roles were masked, how masking was maintained, or whether masking was assessed. The placebo was described as intravenous saline of a volume commensurate with the active treatment, but the record does not report further information about how the two infusions were made indistinguishable.
What does the ITT population mean?
In general, an intention-to-treat approach analyzes participants according to their randomized group, regardless of whether they completed the planned treatment. This approach aims to preserve the benefits of randomization. The registry describes the primary population as including all participants who were randomized. It does not report the analysis denominator, participant flow by group, treatment adherence, or whether the actual analysis followed that definition. The enrollment figure alone cannot establish how many participants contributed data to a particular endpoint.
How should a percentage endpoint be interpreted?
For a binary outcome, each participant is classified as having or not having the event according to the outcome definition. A group percentage expresses the proportion with the event among the participants included in that analysis. The registry’s primary outcome is stated as a percentage of participants dying or requiring ICU admission up to Day 29. The record does not report the event counts or percentages by group, so the endpoint’s observed frequency and the contrast between groups cannot be assessed.
General statistical explanation: a treatment effect for a binary endpoint can be expressed in different ways, including a difference between percentages or a relative measure. Each answers a different question and can convey the same data from a different perspective. No primary-outcome effect measure is reported in the registry record, and no new effect estimate can be recovered from the enrollment figure or the safety counts.
Why does precision matter?
General statistical explanation: a confidence interval communicates uncertainty around an estimate. It reflects the information available in the data and the assumptions of the analysis. When relatively few events are observed, an estimate for a serious binary outcome may be imprecise; however, the event count for this study’s primary endpoint is not reported, so its precision cannot be characterized. A confidence interval is not a guarantee that the true value lies within its bounds, and it does not replace consideration of the endpoint definition or the quality of follow-up.
What can be said about planning assumptions?
The registry record does not report the trial’s sample-size justification or the assumptions used to set enrollment. Any planning illustration based on an observed effect is not a description of the trial’s original design rationale. General explanation: sample-size calculations depend on assumptions about the effect to detect, the chosen significance level, allocation, and the statistical model. Changing those assumptions changes the resulting planning estimate. Such calculations are planning illustrations, not observed power, and cannot substitute for the missing primary-outcome result. The posted record does not establish that any separate planning illustration reflects the sponsor’s original protocol.
Why can over-dispersion matter?
General statistical explanation: over-dispersion occurs when observed variability is greater than a model assumes. If a model does not allow for that extra variability, standard errors may be too small and confidence intervals or tests may convey more certainty than the data warrant. This issue is relevant to some outcome types and models, but the registry record does not identify a primary-outcome model or report an over-dispersion assessment. It therefore cannot be said whether this issue arose in the trial’s analysis.
The registry lists several secondary outcomes, including continuous changes in scores, times to clinical milestones, and durations of care or support. These outcome types can require different definitions and analytic methods. The record does not report enough detail to identify the models, covariates, censoring rules, or missing-data procedures used for those analyses. General methodological explanations should therefore not be mistaken for a reconstruction of the trial’s actual analysis plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 15 outcome measures and 13 analyses, including a primary outcome and multiple secondary outcomes. When many outcomes or analyses are examined, general statistical concerns include multiplicity: the chance of finding an apparently notable result can increase when several hypotheses are tested. Whether and how to address multiplicity depends on the prespecified testing strategy and the intended interpretation of each outcome. The registry record does not report a multiplicity adjustment, a testing hierarchy, or other family-wise error or false-discovery approach. It is not possible to determine from the posted record whether such procedures were used.
The primary-outcome population is described as the ITT population, including all randomized participants. The registry does not report participant flow, the number analyzed for the primary endpoint, or how missing outcome observations were handled. It also does not report whether participants with incomplete follow-up were included through imputation, a model-based approach, or another method. Those approaches can affect estimates and uncertainty, particularly when missingness is related to health status or treatment assignment. The registry record does not provide information to assess that possibility.
The record does not report the full statistical analysis plan, interim analyses, endpoint adjudication procedures, or the timing of any analysis decisions. These are not details that can be inferred from the randomized, double-blind design or the listed outcomes. The primary-outcome results themselves are not reported in the registry record, limiting assessment of both the analysis and the interpretation of any treatment contrast.
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 |
|---|---|---|---|
| Alpha1-Proteinase Inhibitor+Standard Medical Treatment | 5 | 27 | 18.5% |
| Placebo+Standard Medical Treatment | 5 | 27 | 18.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Alpha1-Proteinase Inhibitor+Standard Medical Treatment | 2 of 29 |
| Placebo+Standard Medical Treatment | 1 of 28 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Alpha1-Proteinase Inhibitor+Standard Medical Treatment | 2 of 27 |
| Placebo+Standard Medical Treatment | 8 of 27 |
Most frequent serious adverse event terms
| Event term | Organ system | Alpha1-Proteinase Inhibitor+Standard Medical Treatment | Placebo+Standard Medical Treatment |
|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 2 of 27 | 2 of 27 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 2 of 27 | 1 of 27 |
| Tracheal injury | Injury, poisoning and procedural complications | 1 of 27 | 0 of 27 |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 1 of 27 | 0 of 27 |
| Seizure | Nervous system disorders | 0 of 27 | 1 of 27 |
| Acute kidney injury | Renal and urinary disorders | 1 of 27 | 0 of 27 |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 1 of 27 | 0 of 27 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 0 of 27 | 1 of 27 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Alpha1-Proteinase Inhibitor+Standard Medical Treatment | Placebo+Standard Medical Treatment |
|---|---|---|---|
| Bradycardia | Cardiac disorders | 0 of 27 | 3 of 27 |
| Dyspepsia | Gastrointestinal disorders | 0 of 27 | 2 of 27 |
| Nausea | Gastrointestinal disorders | 0 of 27 | 2 of 27 |
| Pneumonia bacterial | Infections and infestations | 2 of 27 | 0 of 27 |
| Blood pressure increased | Investigations | 0 of 27 | 2 of 27 |
Serious events with the highest arm-level rate: hypoxia (7.4%), respiratory failure (7.4%), tracheal injury (3.7%), muscular weakness (3.7%), seizure (3.7%).
The registry reports serious adverse events in 5 of 27 participants in the liquid alpha1-proteinase inhibitor plus standard medical treatment group and 5 of 27 participants in the placebo plus standard medical treatment group. Other adverse events are reported in 2 of 27 participants in the intervention group and 8 of 27 participants in the placebo group. The registry also lists 2 deaths in the intervention group and 1 in the placebo group. These are observed counts as recorded; they are not estimates of the primary endpoint.
The record lists hypoxia and respiratory failure at 7.4% each among the top serious adverse-event terms, and tracheal injury, muscular weakness, seizure, and acute kidney injury at 3.7% each. The posted information does not establish whether participants could contribute to more than one event term, nor does it provide a causal assessment for each event. Serious adverse-event counts, other adverse-event counts, and deaths should not be added together: the record does not state whether those categories overlap.
General statistical explanation: safety counts are descriptive unless accompanied by a defined comparison and analysis. Differences in counts do not by themselves establish that treatment caused or prevented an event. Interpretation also depends on follow-up, event definitions, exposure, and completeness of reporting, details that are not fully described in the registry record.
12. What the Result Does, and Does Not, Mean
The posted results describe a randomized, double-blind, parallel-group Phase 2 study in hospitalized participants with COVID-19. They identify the treatment strategies, the primary clinical question, and selected safety counts. The registry record does not report the primary-outcome event counts, percentages, effect estimate, confidence interval, or p-value. As a result, the central efficacy comparison cannot be quantified from the posted results.
This absence should not be read as evidence that the groups had the same outcome, or as evidence that one group had a better outcome. It means the registry record does not report the information needed to determine the observed primary-outcome contrast. Likewise, the trial’s terminated status does not indicate why the study ended or what its investigators concluded; the reason for termination is not reported in the registry record.
The safety counts are limited descriptive observations. They show the recorded numbers of participants with serious and other adverse events, and the recorded deaths in each group, but do not by themselves establish causation. The registry does not report enough detail about overlap, follow-up, or analytic procedures to turn these counts into a complete comparative safety assessment.
The brief summary describes an intended clinical question that includes dependence on high-flow oxygen devices or invasive mechanical ventilation on Day 29, while the primary-outcome title names death or ICU admission up to Day 29. Without a more detailed endpoint definition and outcome results, those descriptions should not be treated as interchangeable. The registry record also lists secondary clinical outcomes, but the presence of an outcome name does not establish that its result was reported or that it can answer the primary question.
In statistical terms, the design information explains how the comparison was intended to be made, while the missing outcome information prevents assessment of its magnitude and precision. The conclusions that can be drawn from this registry record are therefore about the study’s design, stated objectives, and limited reported safety data—not about whether the intervention changed the primary clinical outcome.
13. Why This Trial Matters Statistically
This trial is statistically notable because its registry record contains a defined randomized comparison but does not report the primary-outcome result. That distinction illustrates why design details alone are insufficient for evaluating a clinical question. Randomization and masking can strengthen a study’s ability to make a fair comparison, but interpretation still requires outcome data, a clear endpoint definition, and information about the analysis population and uncertainty.
The endpoint description also illustrates the importance of consistent terminology. The registered primary-outcome title refers to death or ICU admission up to Day 29, whereas the brief summary also mentions dependence on high-flow oxygen devices or invasive mechanical ventilation on Day 29. When an outcome is described at different levels of detail, readers need a precise definition to know which events were counted and how the analysis was performed. The registry record does not resolve that distinction.
The listed safety counts further illustrate the difference between descriptive data and an inferential comparison. Counts by group can inform a reader about what was recorded, but their interpretation depends on event definitions, follow-up, possible overlap, and analysis methods. The registry record does not supply all of those details, and the counts do not replace the missing primary-outcome result.
Finally, the terminated status makes transparent reporting especially important, while not establishing any reason for termination. The reason is not reported in the registry record, so the status should not be used to infer an efficacy or safety conclusion. Statistically, this record is a reminder to distinguish what was planned, what was measured, and what was actually reported.
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 limitation for interpretation is that the registry record does not report the primary-outcome result. No event counts, group percentages, effect estimate, confidence interval, or p-value are available for death or ICU admission up to Day 29. This prevents assessment of the direction, size, and precision of the main comparison.
The primary-outcome title and brief summary do not describe exactly the same set of events. The summary additionally refers to dependence on high-flow oxygen devices or invasive mechanical ventilation on Day 29. The registry record does not clarify whether these were part of the primary endpoint or another outcome, so the intended composite cannot be reconstructed from the available descriptions.
The registry lists 57 participants enrolled, while the safety results give 27 participants at risk in each group. The record does not explain the relationship between these figures, nor does it provide participant flow or endpoint-specific analysis denominators. No inference about exclusions, missing follow-up, or the final analysis population should be made from these figures alone.
The record does not report the reason for termination, the sample-size justification, the complete statistical analysis plan, or the handling of missing primary-outcome data. It also does not describe interim analyses or multiplicity procedures. The treatment description for the Day 8 intervention dose is incomplete, and further administration details are not reported. These gaps limit reconstruction of the protocol and analysis.
Safety reporting is also limited: the record lists counts, deaths, and selected serious adverse-event terms but does not fully explain overlap or provide a complete comparative analysis. These limitations are specific to the available registry information and do not establish that the underlying study files lacked additional detail.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19) — NCT04547140.
- Registry record last updated 2023-03-22; status last verified 2023-03.
- Results first posted 2023-03-22.
- 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
NCT04547140 is a Phase 2, multicenter, randomized, double-blind, parallel-group study of liquid alpha1-proteinase inhibitor plus standard medical treatment versus placebo plus standard medical treatment in hospitalized participants with COVID-19. The registry lists enrollment of 57, a study start date of 2021-01-29, a primary completion date of 2021-12-13, and status as terminated.
The registered primary outcome is the percentage of participants dying or requiring ICU admission up to Day 29, with the population defined as all randomized participants. The brief summary also mentions dependence on high-flow oxygen devices or invasive mechanical ventilation on Day 29. The primary-outcome results and reason for termination are not reported in the registry record. Safety information includes serious adverse-event counts, other adverse-event counts, deaths, and selected serious adverse-event terms.