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 Plasma Therapy of COVID-19 in Severely Ill Patients (NCT04359810), a randomized phase 2 study. The primary outcome is Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04359810 |
| Phase | Phase 2 |
| Condition | SARS-CoV-2 Infection |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 223 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Max O'Donnell |
| Results posted | Yes |
2. Clinical Question
Population
Adults with severe COVID-19 were eligible. The brief description specifies adults 18 years of age or older. The condition listed in the registry record is SARS-CoV-2 infection.
Intervention
Participants assigned to the intervention received one unit of convalescent plasma collected from a volunteer who had recovered from COVID-19. The described volume is approximately 200-250 mL. The intervention is also called anti-SARS-CoV-2 plasma.
Comparator
The comparison group received one unit of non-convalescent, standard plasma collected prior to December 2019, described as control plasma. The registry record identifies both study treatments as biological interventions.
Primary question
The trial planned to compare the groups’ day 28 severity outcomes on a 7-point ordinal scale of clinical status. Higher categories represent worse clinical status, from not hospitalized at the lower end to death at the highest category.
The clinical question is whether the distribution of clinical status at day 28 differed between the two randomized groups. This is a comparison across ordered categories, not simply a question about one event such as hospitalization or death. The scale includes two categories for people who are not hospitalized, followed by categories describing hospitalization without oxygen, hospitalization with supplemental oxygen, higher levels of respiratory support, and death. A comparison of the full scale could therefore reflect changes at more than one point along the spectrum of severity.
The registry record describes a study of efficacy and safety in severely ill adults, but it does not give day 28 counts for each category or a numerical estimate comparing the groups. It also does not report a statistical test or confidence interval for this primary outcome. Consequently, the clinical question is clear from the registered endpoint, but the posted record does not show the outcome distribution needed to answer it.
3. Trial Design
This was a phase 2, randomized, double-masked, parallel-group clinical trial. The registry record lists an enrollment of 223 participants. Its brief description states that 219 eligible subjects would be randomized in a 2:1 ratio to high-titer anti-SARS-CoV-2 plasma or non-convalescent fresh frozen plasma. These are two different enrollment figures in the record: one is listed as enrollment, while the other appears in the description of the planned randomization. The record does not explain the distinction.
The intervention group was assigned convalescent plasma from a volunteer who had recovered from COVID-19. The comparator group was assigned standard, non-convalescent plasma collected prior to December 2019. Each arm description refers to one unit, approximately 200-250 mL. Although the brief description calls the intervention high-titer plasma, the registry record does not report measured antibody levels or the criteria used to define a high titer.
The study is listed as completed. Its recorded start date is 2020-04-21, and its primary completion date is 2020-12-30. The registry record does not identify which individuals were masked, describe how allocation was concealed, or give details of the randomization procedure. It also does not report whether the intended allocation ratio was maintained in the final assigned groups.
Parallel-group randomization assigns participants to a study arm and compares outcomes between groups. As a general statistical principle, random assignment can help balance known and unknown participant characteristics across groups on average. It does not guarantee identical groups, particularly in a trial of limited size. Masking can reduce the influence of expectations on care, outcome assessment, or reporting, depending on who is masked and how the process is maintained. The registry record labels the trial double-masked but does not specify those operational details.
The listed secondary outcomes include PCR positivity, SARS-CoV-2 RNA levels, duration of supplemental oxygen, duration of hospitalization, 28-day mortality, time to clinical improvement, and host genetic and transcriptomic differences. The registry record lists nine outcome measures overall. It does not report analysis results for these secondary outcomes.
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 | Convalescent Plasma (Anti-SARS-CoV-2 Plasma) | Non-convalescent Plasma (Control Plasma) |
|---|---|---|
| STARTED | 150 | 73 |
| COMPLETED | 150 | 73 |
| NOT COMPLETED | 0 | 0 |
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.
| Characteristic | Unit | Convalescent Plasma (Anti-SARS-CoV-2 Plasma) | Non-convalescent Plasma (Control Plasma) | Total |
|---|---|---|---|---|
| Participants analysed | 150 | 73 | 223 | |
| Age, Customized: < 60 years old | Participants | 74 | 28 | 102 |
| Age, Customized: 60 - 69 years old | Participants | 35 | 24 | 59 |
| Age, Customized: 70 - 79 years old | Participants | 28 | 16 | 44 |
| Age, Customized: >= 80 years old | Participants | 13 | 5 | 18 |
| Sex: Female, Male: Female | Participants | 96 | 51 | 147 |
| Sex: Female, Male: Male | Participants | 54 | 22 | 76 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: United States | participants | 49 | 24 | 73 |
| Region of Enrollment: Brazil | participants | 101 | 49 | 150 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status, measured over Up to 28 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with day 28 severity outcomes on a 7-point ordinal scale of clinical status. The categories range from not hospitalized to death, with intermediate categories describing hospitalization and levels of respiratory support. A higher category indicates worse clinical status. The registry record gives the assessment timeframe as up to 28 days.
An ordinal scale is useful when a clinical condition can be described by ordered levels of severity rather than by a single yes-or-no event. It can retain distinctions between, for example, hospitalization without oxygen and hospitalization requiring more intensive respiratory support. It also captures outcomes at the most severe end of the scale. As a general statistical concept, ordered categories convey rank information: one category is more severe than another, but the distance between adjacent categories need not be equal.
The scale’s breadth is also a reason for care in interpretation. A group comparison could be based on the distribution across all categories, or on a chosen summary or contrast. Those approaches answer related but not identical questions. The registry record does not report which summary, contrast, or model was used, nor does it give category-specific counts. The title describes a count of participants with day 28 severity outcomes, but no numerical results are posted for the categories.
Without the distribution or a reported comparison, it is not possible to determine from this record whether the groups had different day 28 severity outcomes, how large any difference was, or how precisely it was estimated. The endpoint definition establishes what was intended to be assessed; it is not itself evidence of an observed treatment effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically ordered primary outcome and the two randomized treatment groups, but it does not report the primary outcome results. In particular, no number of participants in each day 28 severity category is given, and no overall comparison, effect estimate, confidence interval, or p-value is reported. The record therefore does not permit a statistical conclusion about how the groups’ day 28 clinical-status distributions compared.
This absence matters because an ordinal endpoint can be summarized in several ways. A comparison might use the full ordering of categories, focus on a particular threshold, or report counts by category. Each form of analysis emphasizes different aspects of the outcome. Without the category counts and analysis method, readers cannot assess whether any apparent difference was concentrated in less severe categories, more severe categories, or spread across the scale. Nor can readers tell whether the reported analysis, if one was performed, preserved the ordinal structure.
A confidence interval, in general, describes the range of effect estimates compatible with the observed data under the assumptions of the analysis. It helps convey precision as well as direction and magnitude. No confidence interval for the primary outcome appears in the registry record, so precision cannot be evaluated. Likewise, a p-value would address compatibility with a specified null hypothesis under an analysis model; it would not by itself show the size or clinical importance of a difference. No primary-outcome p-value is reported.
The record lists adverse-event counts, but they do not substitute for the missing efficacy endpoint. Adverse events and day 28 clinical status answer different questions, and the safety counts do not establish how the ordinal outcome was distributed. The record also lists 28-day mortality as a secondary outcome, but the adverse-event summary’s death counts should not automatically be treated as the secondary mortality analysis. The record does not explain the relationship between those counts and that outcome or provide a formal comparison for mortality.
The study is marked completed, but completion status alone does not establish that results are available in the registry. The record lists zero analyses. It does not report a reason for the absence of primary outcome estimates, state whether analyses were conducted elsewhere, or describe any discrepancy between planned and reported analyses. These details should not be inferred.
The enrollment figure is 223, while the brief description says 219 eligible subjects would be randomized. The record does not clarify whether the difference reflects screening, eligibility, enrollment definitions, or another reason. Neither figure can be assumed to be the analysis population for the primary endpoint. The number assigned to each arm, the number with day 28 outcome data, and the number included in an analysis are not reported.
Accordingly, the statistical interpretation is limited to the structure of the registered question and the information absent from the posted record. No effect estimate can be recovered from the endpoint description alone. Any inference about benefit, lack of benefit, or uncertainty in the comparison would require outcome data and an analysis that are not reported in the registry record.
9. Statistical Methods Explained
The registry record describes a randomized, double-masked, parallel-group phase 2 trial. It identifies a 7-point ordinal primary outcome assessed up to day 28 and lists several secondary outcomes. It does not report the statistical analysis used for the primary endpoint. The following concepts are general explanations of methods relevant to this kind of trial; they are not claims about methods used in this study.
What does randomization contribute?
Randomization assigns participants to treatment groups by chance. In general, this can reduce systematic differences between groups at the start of a trial, including differences in factors that are measured and factors that are not measured. Balance is a property expected over repeated random assignments, not a guarantee that every individual trial will have matching groups. The registry record does not describe the randomization sequence, its implementation, or whether assignment was stratified by participant characteristics.
Allocation concealment is distinct from masking. Concealment concerns whether the upcoming assignment could be known before a participant is enrolled or assigned. Masking concerns whether participants, clinicians, or outcome assessors know the assigned treatment after assignment. The registry labels the trial double-masked, but does not identify which parties were masked or how masking was maintained. The record also does not describe allocation concealment.
How should an ordinal outcome be understood?
An ordinal scale places outcomes in an order, from less severe to more severe, without requiring equal spacing between categories. The registered scale progresses from not hospitalized through increasing levels of respiratory support to death. A statistical analysis may use the ordering to compare the overall distributions, or may reduce the scale to a threshold or selected categories. The choice affects the question being answered and can affect the interpretation of an estimate.
For example, an analysis of the full ordered scale asks whether the pattern of outcomes tends to be more favorable in one group across the ordered categories. A threshold analysis asks about the proportion on one side of a chosen boundary. A category-by-category presentation preserves the counts but does not by itself provide a single summary of the comparison. These are general possibilities, not methods identified in the registry record. The record does not state whether the primary analysis used an ordinal regression model, a rank-based method, a dichotomized outcome, or another approach.
What would an effect estimate and interval add?
An effect estimate describes the contrast between groups using a defined statistical scale. Its meaning depends on the endpoint and model: a difference in probabilities, an odds-based measure, or a rank-based measure, for example, would not have the same interpretation. The registry record does not report an effect estimate for the primary outcome, so its scale and direction cannot be assessed.
A confidence interval conveys uncertainty around an estimate under the assumptions of the method used. A narrower interval generally indicates greater precision than a wider interval, although precision is not the same as clinical importance. Intervals also help distinguish data compatible with effects in different directions or magnitudes. No primary endpoint confidence interval is reported. General statistical interpretation therefore cannot be applied to a numerical treatment contrast in this record.
A p-value is a measure calculated under a specified statistical model and null hypothesis. It does not quantify the probability that a treatment works, and it does not measure the size of an effect. A p-value also cannot replace an effect estimate and interval. The registry record does not report a p-value or identify a primary-outcome test.
Why do analysis populations matter?
Trials can define more than one population for analysis. An analysis based on participants as randomized generally aims to preserve the comparison created by random assignment, while other populations may depend on receiving treatment or meeting additional criteria. These choices can alter the population represented by the estimate. The registry record does not define an intention-to-treat, per-protocol, or safety analysis population for the primary outcome, nor does it report the number analyzed in either group.
Missing outcome data can also affect interpretation. If some participants lack day 28 status, the analysis must decide how to handle those missing observations. Complete-case analysis, imputation, and sensitivity analyses are general approaches with different assumptions. A missing-data method should be described because results can depend on whether missingness is related to observed or unobserved outcomes. The registry record does not report missingness counts, reasons for missing data, or a method for handling missing primary outcomes.
Why is multiplicity relevant?
When a trial assesses multiple outcomes, time points, or subgroup comparisons, repeated testing can increase the chance of at least one apparently notable result by chance. Statistical plans sometimes define one primary comparison, adjust for multiple testing, or distinguish confirmatory from exploratory analyses. The record lists a primary outcome and multiple secondary outcomes, but does not report a multiplicity strategy, analysis hierarchy, or which outcomes were treated as confirmatory. No conclusion about adjustment should be inferred.
The registry record also does not report interim analyses, stopping rules, or a sample-size justification. Those items should not be reconstructed from the fact that the study is phase 2 or from its enrollment figures. In general, a sample-size calculation depends on assumptions about the target effect, outcome variability or event frequency, significance level, power, allocation, and analysis method. Without the trial’s stated assumptions, the rationale for its enrollment cannot be evaluated.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary day 28 ordinal clinical-status outcome and several secondary outcomes, including PCR positivity, RNA levels, duration of supplemental oxygen, hospitalization duration, 28-day mortality, time to clinical improvement, and host genetic and transcriptomic measures. It lists nine outcome measures overall. However, it does not describe how the outcomes were prioritized for statistical testing or whether any procedure was planned to address multiplicity.
Multiplicity is a general concern when a study evaluates several outcomes, time points, or contrasts. The more analyses considered, the greater the possibility that one result may appear notable by chance if each is interpreted without context. A prespecified hierarchy or adjustment can help clarify which results are confirmatory and how the overall interpretation should be made. The registry record does not report such a hierarchy, an adjustment method, or the results of any secondary-outcome analyses. It also does not report interim analyses or associated decision rules.
The record does not report the number of participants with available day 28 outcomes, the number missing, or reasons for missingness. It does not describe imputation, censoring, or sensitivity analyses for missing primary outcomes. These omissions prevent assessment of how complete the endpoint data were and whether assumptions about missing outcomes could affect the comparison.
The analysis populations are also not specified. The registry record does not say how many randomized participants were included in the primary analysis or whether the analysis followed assignment regardless of treatment received. It does not provide participant flow or explain how exclusions, withdrawals, or protocol deviations were handled. The enrollment listing of 223 and the brief description’s planned randomization of 219 do not establish the number analyzed. These details are not reported in the registry record.
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 |
|---|---|---|---|
| Convalescent Plasma (Anti-SARS-CoV-2 Plasma) | 39 | 147 | 26.5% |
| Non-convalescent Plasma (Control Plasma) | 26 | 72 | 36.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Convalescent Plasma (Anti-SARS-CoV-2 Plasma) | 19 of 150 |
| Non-convalescent Plasma (Control Plasma) | 18 of 73 |
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 |
|---|---|
| Convalescent Plasma (Anti-SARS-CoV-2 Plasma) | 4 of 147 |
| Non-convalescent Plasma (Control Plasma) | 3 of 72 |
Most frequent serious adverse event terms
| Event term | Organ system | Convalescent Plasma (Anti-SARS-CoV-2 Plasma) | Non-convalescent Plasma (Control Plasma) |
|---|---|---|---|
| Pulmonary adverse event | Respiratory, thoracic and mediastinal disorders | 24 of 147 | 16 of 72 |
| Cardiovascular event | Vascular disorders | 16 of 147 | 12 of 72 |
| Infectious adverse event | Infections and infestations | 5 of 147 | 10 of 72 |
| Renal/metabolic adverse event | Renal and urinary disorders | 7 of 147 | 5 of 72 |
| Hematologic adverse event | Blood and lymphatic system disorders | 6 of 147 | 0 of 72 |
| Inflammatory adverse event | Immune system disorders | 1 of 147 | 0 of 72 |
| Gastrointestinal/hepatic adverse event | Gastrointestinal disorders | 0 of 147 | 1 of 72 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Convalescent Plasma (Anti-SARS-CoV-2 Plasma) | Non-convalescent Plasma (Control Plasma) |
|---|---|---|---|
| Transfusion-related circulatory overload | Vascular disorders | 2 of 147 | 1 of 72 |
| Anemia, worsening | Blood and lymphatic system disorders | 1 of 147 | 1 of 72 |
| Urticaria | Skin and subcutaneous tissue disorders | 1 of 147 | 1 of 72 |
| Skin rash | Skin and subcutaneous tissue disorders | 1 of 147 | 0 of 72 |
| Possible febrile non-hemolytic transfusion reaction | General disorders | 0 of 147 | 1 of 72 |
Serious events with the highest arm-level rate: pulmonary adverse event (22.2%), cardiovascular event (16.7%), infectious adverse event (13.9%), renal/metabolic adverse event (6.9%), hematologic adverse event (4.1%).
The adverse-event summary lists 147 participants at risk for serious events in the convalescent-plasma group, with 39 affected, and 72 at risk in the non-convalescent-plasma group, with 26 affected. For other events, it lists 147 at risk and 4 affected in the convalescent group, and 72 at risk and 3 affected in the comparator group. The listed death counts are 19 and 18, respectively. These are counts in the registry’s adverse-event summary, not a reported comparison adjusted for follow-up or participant characteristics.
The record also gives percentages for serious-event terms: pulmonary adverse event, 22.2%; cardiovascular event, 16.7%; infectious adverse event, 13.9%; renal/metabolic adverse event, 6.9%; hematologic adverse event, 4.1%; and gastrointestinal/hepatic adverse event, 1.4%. It does not give arm-specific percentages for these terms in the posted summary. The denominator and detailed event definitions are not reported there, so the percentages should not be interpreted as arm-specific risks.
Counts alone do not establish that one treatment caused more or fewer events. Interpretation depends on how events were defined and collected, how long participants were followed, whether participants could have multiple events, and how missing safety data were handled. The record does not provide those details or a statistical comparison of the groups. The death counts should not be assumed to be the formal 28-day mortality analysis, which is listed separately as a secondary outcome.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, double-masked phase 2 trial was conducted to compare convalescent plasma with non-convalescent plasma in adults with severe COVID-19. It defines a day 28 severity outcome using an ordered scale that ranges from not hospitalized to death. Those features describe the study question and design, but they do not show the trial’s primary outcome result.
The record does not report how many participants in either group fell into each severity category, a summary comparison of the ordinal outcome, or an estimate with a confidence interval. It therefore does not establish the direction, size, or precision of any difference between groups. The absence of a reported result is not evidence that the groups were the same, and it is not evidence that they differed. Both interpretations would require outcome data and a specified analysis.
The adverse-event summary provides event counts and percentages for selected serious-event terms, but those figures have a different role from the primary efficacy endpoint. Without detailed definitions, follow-up information, denominators for the listed terms, and a statistical comparison, they should be read descriptively. They do not by themselves establish a causal safety difference. Similarly, listed deaths in the adverse-event summary should not be treated as a complete analysis of the separately listed 28-day mortality outcome.
The record’s completed status indicates that the study is marked completed in the registry, not that all results are displayed there. The listing includes an enrollment of 223, while the brief description states that 219 eligible subjects would be randomized. The record does not explain the difference or identify the number of participants with outcome data. It also does not describe the analysis population, handling of missing data, or multiplicity strategy.
In statistical terms, the posted information is enough to describe the planned comparison and endpoint, but not enough to estimate the treatment contrast or its uncertainty. No claim about efficacy or lack of efficacy follows from the absence of numerical primary results. Further interpretation would require the outcome distributions, methods, and analysis results, none of which are reported in the registry record.
13. Why This Trial Matters Statistically
This trial raises a useful statistical example because its primary outcome is not a simple binary event. The 7-point clinical-status scale orders outcomes from not hospitalized through levels of hospitalization and respiratory support to death. Such scales can retain clinically relevant gradations that would be lost if the outcome were reduced to a single threshold. At the same time, a scale’s ordering does not mean that the distance between adjacent categories is equal, so the choice of analysis matters.
Randomized, double-masked, parallel-group design provides a framework for comparing assigned treatments while limiting some sources of systematic bias. The registry record describes these design features, but its brief methods information does not identify who was masked, how assignments were concealed, or how the primary outcome was analyzed. This is a reminder that design labels alone do not supply all the details needed to assess risk of bias or interpret an estimate.
The trial also illustrates why endpoint definitions and endpoint results must be distinguished. A clear description of the day 28 scale tells readers what was intended to be measured. It does not show how participants were distributed across categories or what comparison the investigators found. Without the primary outcome counts and analysis, the registry record cannot support an estimate of effect or precision.
Finally, the listing of multiple secondary outcomes makes analysis planning important. In general, a prespecified strategy helps readers understand which comparisons were central and how multiple results were handled. The registry record does not report that strategy, participant flow, missing-data methods, or a sample-size justification. These omissions limit statistical interpretation even though the trial’s population, interventions, and primary clinical question are identifiable.
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 main trial-specific limitation of the available record is that it does not report numerical results for the primary day 28 ordinal outcome. No category counts, effect estimate, confidence interval, or p-value are available. The direction and magnitude of the group comparison, and the precision of any estimate, therefore cannot be evaluated.
The record does not identify the primary analysis method or explain how the ordinal scale was summarized. It also does not report analysis populations, the number of participants with available outcome data, missing-data handling, participant flow, or reasons for exclusions or withdrawals. These omissions make it impossible to judge how the analyzed population related to the randomized groups or whether incomplete follow-up could have influenced the comparison.
The listed enrollment is 223, whereas the brief description says 219 eligible subjects would be randomized. The registry record does not explain this difference. It does not report the number randomized to each arm or whether the stated 2:1 allocation was achieved. The recorded enrollment should not be treated as the number analyzed for the primary endpoint.
Although the study is labeled double-masked, the record does not say which parties were masked or describe allocation concealment. It also does not give the criteria for high-titer plasma, measured antibody levels, or details of treatment delivery beyond the one-unit descriptions. These details are not reported in the registry record.
The record lists multiple secondary outcomes but does not describe a multiplicity strategy or provide their analysis results. It does not report interim analyses, stopping rules, or a sample-size justification. Safety information is limited to the listed counts and selected percentages, without enough detail to establish event definitions, arm-specific term rates, or comparative analyses. These limitations concern what can be assessed from the registry record; they do not establish that additional information does not exist elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Plasma Therapy of COVID-19 in Severely Ill Patients — NCT04359810.
- Registry record last updated 2024-09-19; status last verified 2024-08.
- Results first posted 2024-09-19.
- 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
The registry record describes NCT04359810, a completed phase 2, randomized, double-masked, parallel-group trial of convalescent plasma versus non-convalescent plasma in adults with severe COVID-19. The registered primary outcome is day 28 clinical status on a 7-point ordinal scale, with higher categories indicating worse status. The study lists enrollment of 223; its brief description says 219 eligible subjects would be randomized in a 2:1 ratio. The record does not explain the difference between those figures.
The intervention is described as one unit of convalescent plasma, and the comparator as one unit of standard non-convalescent plasma. The record lists secondary outcomes including virologic measures, oxygen and hospitalization duration, mortality, clinical improvement, and host genetic and transcriptomic measures.
Although the trial is marked completed, no primary-outcome category counts or statistical comparison are reported. The analysis method, analysis populations, missing-data handling, multiplicity approach, and sample-size justification are not reported in the registry record. The adverse-event summary contains counts and selected serious-event percentages, but no comparative safety analysis is described.