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 Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19 (NCT04860518), a randomized phase 2 study. The primary outcome is Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04860518 |
| Phase | Phase 2 |
| Condition | Covid19 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 7 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Faron Pharmaceuticals Ltd |
| Results posted | Yes |
2. Clinical Question
Population
Hospitalized patients with COVID-19 infection were eligible for this study. The registry record lists enrollment of 7. The primary outcome description notes that only 4 patients had analyzable Day 14 data, so the posted clinical-status result reflects a small subset of the enrolled group.
Intervention
The investigational treatment was intravenous recombinant human interferon beta-1a, also identified as FP-1201-lyo and IV IFN beta-1a. The study description specifies a daily dose of 10 μg for 6 consecutive days during hospitalization. The active-drug arm also received a separate saline injection.
Comparator
The active comparator was intravenous dexamethasone, administered daily for 6 consecutive days according to the study summary. The comparator arm received a separate saline injection as well as dexamethasone. The registry record describes the study as randomized, double-blind, and controlled.
Primary question
The primary question was whether Day 14 clinical status differed between the interferon beta-1a and dexamethasone groups, measured using the WHO 9-point ordinal scale. The posted outcome is a mean score for each group. It does not include an inferential comparison, confidence interval, or reported estimate of the difference between groups.
3. Trial Design
This was a Phase II, randomized, parallel-group study comparing intravenous interferon beta-1a with intravenous dexamethasone in hospitalized patients with COVID-19. The registry describes the study as multi-center, double-blind, and controlled; the masking classification is quadruple. The planned comparison was between two active treatments, rather than between an active treatment and an untreated control.
The study summary describes daily treatment for 6 consecutive days, with daily in-hospital assessments for a maximum of 28 days. Study-specific assessments were scheduled from pre-dose Day 1 through Day 28, alongside routine clinical assessments. The registry lists enrollment of 7. The recorded start date is 2021-08-23, and the primary completion date is 2022-04-04. The study status is terminated.
The registry record does not report why the study was terminated, how randomization was generated or concealed, or the operational details of the masking procedures. It also does not report a rationale for the enrollment target or a statistical plan describing the intended primary comparison. These omissions limit what can be concluded about how the planned design was implemented and how the posted results relate to the original 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.
Overall Study
| Stage | IV IFN Beta-1a | IV Dexamethasone |
|---|---|---|
| STARTED | 3 | 4 |
| COMPLETED | 2 | 3 |
| NOT COMPLETED | 1 | 1 |
Reasons for not completing this period:
| Reason | IV IFN Beta-1a | IV Dexamethasone |
|---|---|---|
| Screen Failure, patient was not dosed | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: Only 4 patients had analyzable data on D14
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 | IV IFN Beta-1a | IV Dexamethasone | Total |
|---|---|---|---|---|
| Participants analysed | 3 | 4 | 7 | |
| Age, Continuous | years | 60.0 (SD 7.00) | 55.8 (SD 15.69) | 57.6 (SD 12.03) |
| Sex: Female, Male: Female | Participants | 2 | 2 | 4 |
| Sex: Female, Male: Male | Participants | 1 | 2 | 3 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 | 3 | 6 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Black or African American | participants | 1 | 1 | 2 |
| Race/Ethnicity, Customized: White and Other (not specified) | participants | 0 | 2 | 2 |
| Race/Ethnicity, Customized: White | participants | 2 | 1 | 3 |
| Eastern Cooperative Oncology Group (ECOG) status: 0: Able to carry out all normal activity without restriction | Participants | 3 | 3 | 6 |
| Eastern Cooperative Oncology Group (ECOG) status: 2: Ambulatory and capable of all self-care but unable to carry out any work activities | Participants | 0 | 1 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Clinical Status at Day 14 (First Day of Study Drug is Day 1) as Measured by WHO 9-point Ordinal Scale, measured over Day 14.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is clinical status on Day 14, measured with the WHO 9-point ordinal scale. Its categories range from no detectable infection through progressively greater levels of hospitalization and respiratory or organ support, to death. The scale is intended to represent a broad clinical state rather than a single symptom or laboratory measure. In this study, it provides a way to describe patients’ status at a specified point in follow-up.
The ordering of the scale carries clinical meaning: higher categories correspond to more severe states. However, the distance between neighboring categories is not necessarily equal. A mean score is therefore a compact summary of the group’s recorded scores, but it does not show how many patients occupied each category or whether individual participants improved or worsened. The registry specifies a mean and standard deviation for this continuous-style summary.
The Day 14 outcome description says that only 4 patients had analyzable data. Each treatment group has a reported mean of 2.0 units and a standard deviation of 0.0, with 2 patients per group. Those summaries describe the recorded values, but the small analyzable group and the ordinal nature of the scale constrain interpretation.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted Day 14 mean is 2.0 units for the IV IFN beta-1a group and 2.0 units for the IV dexamethasone group. Each mean is based on 2 patients, and each reported standard deviation is 0.0. The values are identical as reported. They describe the available observations; they are not evidence of a precise or definitive equivalence between the treatments.
Only 4 patients had analyzable Day 14 data, according to the primary outcome description. With so few observations, the reported summaries have limited ability to characterize variability or to support a stable comparison between groups. A standard deviation of 0.0 means that no variation is represented in the reported values within each group. It does not establish that the treatments have no variability in a broader population, and it does not resolve uncertainty about patients without analyzable endpoint data.
The registry record does not report a confidence interval, p-value, or other inferential result for the primary comparison. It also reports that values were missing or not estimable for a two-arm comparison of this continuous endpoint. Consequently, the posted mean and standard deviation should be read descriptively, not as a formal test of a treatment difference. No adjusted or unadjusted treatment-effect estimate is reported in the registry record.
The scale’s categories are ordered but need not be equally spaced. A mean can be useful as a compact summary, yet the same mean can arise from different distributions of individual scores. The group means alone therefore do not reveal each patient’s clinical category or the distribution of status across the scale. The registry record does not report category counts for the primary endpoint.
The broader study record lists mortality outcomes at Day 28 and Day 90, but the primary result concerns Day 14 clinical status. Those mortality outcomes should not be treated as though they were the primary endpoint or as though their results were reported in the record. Overall, the available primary-outcome statistics describe a very small analyzable group and provide no formal estimate of comparative uncertainty.
9. Statistical Methods Explained
The posted primary endpoint is summarized as a mean with a standard deviation. These statistics describe the observed values in each treatment group. The mean gives a single center summary, while the standard deviation describes how spread out the recorded values are around that mean. Neither statistic, by itself, indicates how precisely a treatment effect has been estimated.
What does the mean represent for an ordinal scale?
The WHO scale places clinical states in an ordered sequence. A mean treats the numerical steps as though they can be combined into an average score. That can offer a concise description, but it does not preserve all the information in the category distribution. In particular, the scale’s ordered categories do not guarantee that moving between neighboring categories represents the same amount of clinical change. For that reason, the mean should be considered alongside the scale definition and the number of observations used to calculate it.
The reported group means are both 2.0 units. The reported standard deviations are both 0.0, and there are 2 patients in each group. These summaries give no indication of variation among the recorded values within either group. They also do not reveal which category each patient occupied unless the underlying individual or category-level data are reported separately. The registry record does not report those category counts.
Why do confidence intervals and tests matter?
A confidence interval is a general statistical method for expressing the uncertainty around an estimated quantity, such as a difference between group means. It helps readers distinguish the observed estimate from the range of values that may remain compatible with the data and analysis assumptions. A p-value is a general measure used in a specified hypothesis-testing framework; it does not state the probability that a treatment works, nor does it measure the size or clinical importance of an effect.
Neither a confidence interval nor a p-value for the primary two-arm comparison is reported in the registry record. The record also indicates that values were missing or not estimable for a two-arm comparison of this continuous endpoint. In the absence of a reported comparative estimate and its uncertainty, the matching means cannot be translated into a formal conclusion about the size or precision of a treatment difference.
What does a small analyzable group imply?
General statistical reasoning indicates that estimates from very small groups are sensitive to the observed values. A small dataset also provides little information for estimating variability, assessing whether modeling assumptions are reasonable, or examining whether results differ across participant subgroups. Here, the outcome description states that only 4 patients had analyzable Day 14 data. The record does not report why data were unavailable for other enrolled participants, so the effect of missing endpoint information cannot be assessed from the registry entry.
Missing outcome information can affect interpretation if the people with observed data differ systematically from those without observed data. This is a general concern, not evidence that such a pattern occurred in this study. The registry record does not describe a missing-data method, sensitivity analysis, or analysis population definition for the primary result. It is therefore not possible to determine how missing values were handled or whether the posted summaries represent a prespecified population.
How should planning calculations be read?
General sample-size planning uses assumptions about the target effect, variability, allocation, and statistical procedure to illustrate how many participants might be needed for a specified design. Such calculations are planning illustrations, not evidence about the probability that an observed result is true. They are also not observed power. The registry’s planning note describes a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect defined as a stated share of the observed effect. The note does not establish that these assumptions were part of the trial’s original design.
The registry record does not report the study’s own sample-size justification. Moreover, a planning calculation based on an observed effect depends on the effect estimate being interpretable. In this case, the registry reports that a two-arm comparison for the continuous endpoint was not estimable. Any planning illustration should therefore be distinguished from a completed comparative analysis and from the study’s actual enrollment, which was 7.
Finally, randomized assignment supports a planned comparison of treatment groups, but the strength of that comparison depends on the available outcome data and the analysis. The record identifies randomized allocation and parallel groups, yet it does not report the randomization method, a primary analysis model, adjustment variables, or inferential results. Those details should not be inferred from the design labels alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary outcome of Day 14 clinical status and two secondary outcomes: in-hospital mortality at Day 28 and Day 90, and overall all-cause mortality at Day 28 and Day 90. Multiple outcomes can create a multiplicity issue when several hypotheses are tested, because considering many results may increase the chance of a chance finding. Whether and how to address that issue depends on the prespecified analysis plan.
The registry record does not report a multiplicity adjustment, a hierarchy for testing outcomes, or an analysis plan specifying how the primary and secondary outcomes would be interpreted together. It also reports no posted analyses. The mortality outcomes are listed, but results for those outcomes are not reported in the registry record. Their presence should not be taken as evidence that a multiplicity procedure was or was not applied.
The primary endpoint description states that only 4 patients had analyzable Day 14 data. The record does not explain why data were unavailable, define the analysis population, state how missing values were handled, or report sensitivity analyses. These omissions leave uncertainty about the relationship between the enrolled group and the participants contributing to the primary outcome. General missing-data methods can rely on different assumptions; without the analysis details, readers cannot determine which assumptions were used or assess how sensitive the result may be to missingness.
The study’s own statistical plan, including any interim analyses, is not reported in the registry record. No interim monitoring procedure or stopping rule should be inferred from the study’s terminated status.
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 |
|---|---|---|---|
| IV IFN Beta-1a | 0 | 2 | 0.0% |
| IV Dexamethasone | 2 | 3 | 66.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| IV IFN Beta-1a | 0 of 2 |
| IV Dexamethasone | 0 of 3 |
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 |
|---|---|
| IV IFN Beta-1a | 1 of 2 |
| IV Dexamethasone | 2 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | IV IFN Beta-1a | IV Dexamethasone |
|---|---|---|---|
| dehydration | Metabolism and nutrition disorders | 0 of 2 | 1 of 3 |
| head injury | Injury, poisoning and procedural complications | 0 of 2 | 1 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | IV IFN Beta-1a | IV Dexamethasone |
|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | 1 of 2 | 0 of 3 |
| Hypokalemia | Metabolism and nutrition disorders | 1 of 2 | 0 of 3 |
| Hypnoatremia | Metabolism and nutrition disorders | 1 of 2 | 0 of 3 |
| Subdural hematoma | Injury, poisoning and procedural complications | 0 of 2 | 1 of 3 |
| Seizure | Nervous system disorders | 0 of 2 | 1 of 3 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 1 of 2 | 0 of 3 |
Serious events with the highest arm-level rate: dehydration (33.3%), head injury (33.3%).
The adverse-event summary distinguishes participants at risk from participants affected. For serious adverse events, the IV IFN beta-1a group has 2 participants at risk and 0 affected; the IV dexamethasone group has 3 at risk and 2 affected. For other adverse events, the corresponding counts are 2 at risk and 1 affected for IV IFN beta-1a, and 3 at risk and 2 affected for IV dexamethasone. The record lists 0 deaths in each group.
These are small counts and should be read as descriptive observations, not as stable estimates of comparative safety. The record does not report adjusted comparisons or uncertainty intervals for these figures. The listed serious-event terms include dehydration at 33.3% and head injury at 33.3%; the registry record does not provide enough detail in these entries to interpret those percentages as group-specific risks. Counts of affected participants and event-term percentages are not interchangeable.
The adverse-event summary covers the participants represented in its risk counts. It should not be assumed that its denominators match the analyzable population for the Day 14 endpoint. The registry record does not provide a detailed account of event timing, attribution, or the analysis conventions used for these summaries.
12. What the Result Does, and Does Not, Mean
The posted primary result establishes what was recorded for the analyzable Day 14 observations: both groups have a mean WHO ordinal-scale score of 2.0 units, a standard deviation of 0.0, and 2 patients contributing to each group summary. The registry outcome description states that only 4 patients had analyzable data. These figures are descriptive and refer to the small set of observations available for this endpoint.
The result does not establish that the treatments are equivalent, that their effects are identical in a wider population, or that any difference is absent. A formal claim of equivalence would require an appropriate design and analysis, including a defined margin and an estimate of uncertainty; such information is not reported in the registry record. The identical means alone do not answer those questions.
The result also does not establish whether either treatment changes clinical status relative to no treatment. The comparator was dexamethasone, and no untreated control group is listed. Nor does the Day 14 mean reveal individual trajectories, the distribution of scores across categories, or whether missing outcome data could alter the interpretation. Those details are not reported in the registry record.
The study was terminated, but the record does not report the reason. Termination alone does not explain whether the cause was related to recruitment, operations, safety, or another matter, and no such reason should be inferred. The enrollment of 7 and the 4 analyzable Day 14 observations indicate the limited scale of the posted evidence, but do not by themselves explain why the study ended or why outcome data were unavailable.
The most defensible reading is therefore narrow: the record reports matching descriptive means for the small analyzable groups, while a formal two-arm comparison of the continuous endpoint was not estimable. The posted data do not support a broader conclusion about comparative efficacy or safety.
13. Why This Trial Matters Statistically
This study illustrates why a randomized design and a posted numerical result are not, by themselves, enough to establish a precise treatment comparison. The registry describes a Phase II randomized study with two active treatment groups, but only 4 patients had analyzable data for the primary Day 14 outcome. The means are identical as reported, yet the record does not provide an inferential comparison or an uncertainty interval.
It also illustrates the distinction between outcome measurement and statistical interpretation. The WHO scale compresses several clinically different states into an ordered score. A mean can summarize those scores, but it cannot show the category distribution or the clinical paths that produced it. The standard deviation of 0.0 in these small groups describes the posted observations, not certainty about a broader population.
For clinical researchers, the record highlights the value of clearly reporting analysis populations, missing-data handling, outcome distributions, and prespecified methods. Without those details, readers cannot evaluate how the available observations relate to the enrolled group or how the planned comparison was intended to work. The absence of an estimable comparison is itself important information: a descriptive result should not be mistaken for a completed test of a treatment hypothesis.
The study also shows why registered secondary outcomes and adverse-event counts need context. Outcome listings do not substitute for posted results, and small safety counts cannot provide a stable comparative estimate. Interpreting each result within its denominator, endpoint definition, and analysis framework is essential.
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 has data for only 4 patients, with 2 contributing to each group summary. That small analyzable group limits the information available to describe variation and compare the treatments. The reported standard deviations of 0.0 should not be read as evidence of certainty or as a guarantee that broader patient outcomes would show no variability.
The registry record states that a two-arm comparison for the continuous endpoint was not estimable. It does not report a confidence interval, p-value, adjusted effect estimate, category-level endpoint counts, or individual participant outcomes. Consequently, readers cannot assess the precision of a comparative estimate, the distribution of clinical-status categories, or the influence of individual observations.
The reason that only 4 patients had analyzable Day 14 data is not reported in the registry record. The record also does not describe missing-data methods, the primary analysis population, the statistical model, or sensitivity analyses. The study’s own sample-size justification and statistical analysis plan are not reported. These omissions prevent assessment of how the posted endpoint result was intended to be analyzed and how robust it may be to alternative assumptions.
The study status is terminated, but the reason for termination is not reported in the registry record. The listed secondary mortality outcomes have no posted results in the registry record described, and the adverse-event entries provide limited detail for interpretation. These limitations are specific to this record and should be kept separate from conclusions about the treatment itself.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19 — NCT04860518.
- Registry record last updated 2023-07-21; status last verified 2023-07.
- Results first posted 2022-10-14.
- 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
NCT04860518 is a Phase II randomized, parallel-group, quadruple-masked study comparing IV IFN beta-1a with IV dexamethasone in hospitalized patients with COVID-19. The registry describes a multi-center, double-blind study, with treatment administered daily for 6 consecutive days. Enrollment was 7; the recorded start date was 2021-08-23, the primary completion date was 2022-04-04, and the status is terminated.
The primary endpoint was Day 14 clinical status on the WHO 9-point ordinal scale. The outcome description states that only 4 patients had analyzable data. Each group had 2 participants contributing a mean of 2.0 units and a standard deviation of 0.0. The record indicates that a two-arm comparison of the continuous endpoint was not estimable and does not report an inferential result. The reason for termination, statistical analysis plan, and missing-data approach are not reported in the registry record.