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 Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia (NCT04467840), a randomized phase 2, phase 3 study. The primary outcome is Supplemental Oxygen Requirement.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04467840 |
| Phase | Phase 2, Phase 3 |
| Condition | COVID-19, Lung Infection |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 475 |
| Arms in the primary outcome | n/a |
| Lead sponsor | RedHill Biopharma Limited |
| Results posted | Yes |
2. Clinical Question
Population
Adults hospitalized with severe SARS-CoV-2 positive pneumonia. The primary endpoint population is the modified ITT population: randomized subjects who received at least one dose of study medication.
Intervention
Opaganib in addition to standard of care. The registry describes oral administration of 2 x 250 mg capsules, or 500 mg, every 12 hours. When required, the medication could be made into a suspension and given by nasogastric tube.
Comparator
A matching placebo in addition to standard of care, with the same described administration schedule and possible suspension form for nasogastric tube delivery.
Primary question
Did the proportion of subjects no longer requiring supplemental oxygen for at least 24 hours by Day 14 differ between the opaganib and placebo groups, with the outcome assessed as maintained up to Day 42?
The question concerns a change in a form of respiratory support, rather than a laboratory measurement alone. The registry frames the endpoint as the proportion of patients who meet the oxygen criterion, so a comparative interpretation would need the number meeting that criterion and the relevant analysis population in each group, along with an estimate of the between-group difference and its precision.
The record identifies a modified ITT population for the primary endpoint, defined by randomization and receipt of at least one dose. This definition is narrower than a population consisting of every randomized subject. The numerical primary-endpoint results and a single comparison are not reported in the registry record. The registry entries therefore establish the clinical question and its population, but do not show the result of that comparison.
3. Trial Design
The registry describes a randomized, double-blind, parallel-group phase 2/3 study comparing opaganib with matching placebo. It was conducted in adults hospitalized with severe SARS-CoV-2 positive pneumonia, and the record describes it as multicenter. Both groups received standard of care in addition to their assigned study medication. The listed enrollment is 475.
The opaganib regimen is described as 2 x 250 mg capsules, or 500 mg, every 12 hours. The matching placebo is described with the same capsule quantity and schedule. For either group, the registry allows a suspension form and administration by nasogastric tube when required. The masking designation is quadruple. The record does not explain which roles were masked or how masking was maintained.
The study includes PHASE2 and PHASE3 designations and is marked completed. Its recorded start date is 2020-08-21, and its primary completion date is 2021-07-18. The record identifies COVID-19 and lung infection as conditions. The sponsor is RedHill Biopharma Limited.
The primary outcome is supplemental oxygen requirement, assessed over 14 days and maintained up to 42 days. The outcome description focuses on no longer requiring supplemental oxygen for at least 24 hours by Day 14. The registry also lists secondary outcomes involving changes on the WHO Ordinal Scale for Clinical Improvement, oxygen flow via nasal cannula, hospital discharge, intubation and mechanical ventilation, SARS-CoV-2 swabs, and mortality due to any cause.
Randomization is intended, in general, to support a fair comparison by distributing prognostic factors across treatment groups. Blinding is intended to limit influences on care, assessment, and reporting. These are general purposes of the design features, not evidence that balance or masking was achieved in this particular study. Details of the randomization procedure, concealment, and masking assessment are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Opaganib | Placebo |
|---|---|---|
| STARTED | 237 | 238 |
| mITT Population | 230 | 233 |
| COMPLETED | 186 | 186 |
| NOT COMPLETED | 51 | 52 |
Reasons for not completing this period:
| Reason | Opaganib | Placebo |
|---|---|---|
| Death | 35 | 39 |
| Withdrawal by Subject | 8 | 4 |
| Adverse Event | 2 | 0 |
| Lost to Follow-up | 1 | 3 |
| Physician Decision | 1 | 0 |
| Other | 1 | 5 |
| Missing study completion status | 3 | 1 |
Analysis population for the primary outcome, as defined in the registry: Modified ITT (mITT) population defined as randomized subjects who received at least one dose of study medication
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 | Opaganib | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 237 | 238 | 475 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 189 | 169 | 358 |
| Age, Categorical: >=65 years | Participants | 48 | 69 | 117 |
| Age, Continuous | Years | 55.6 (SD 12.05) | 57.3 (SD 12.74) | 56.5 (SD 12.42) |
| Sex: Female, Male: Female | Participants | 86 | 76 | 162 |
| Sex: Female, Male: Male | Participants | 151 | 162 | 313 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 5 | 4 | 9 |
| 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 | 10 | 10 | 20 |
| Race (NIH/OMB): White | Participants | 197 | 203 | 400 |
| Race (NIH/OMB): More than one race | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 23 | 18 | 41 |
| Region of Enrollment: Colombia | participants | 10 | 8 | 18 |
| Region of Enrollment: Brazil | participants | 61 | 62 | 123 |
| Region of Enrollment: Poland | participants | 12 | 16 | 28 |
| Region of Enrollment: Italy | participants | 25 | 28 | 53 |
| Region of Enrollment: Mexico | participants | 7 | 4 | 11 |
| Region of Enrollment: Israel | participants | 43 | 40 | 83 |
| Region of Enrollment: Russia | participants | 79 | 80 | 159 |
| HbA1c at Screening: <6.5 and not on active treatment with insulin or oral hypoglycemics | Participants | 154 | 157 | 311 |
| HbA1c at Screening: ≥6.5 or on active treatment with insulin or oral hypoglycemics | Participants | 83 | 80 | 163 |
| HbA1c at Screening: Missing | Participants | 0 | 1 | 1 |
| BMI at Baseline (kg/m^2) | kg/m2 | 31.02 (SD 5.676) | 30.47 (SD 5.158) | 30.74 (SD 5.421) |
| Supplemental Oxygen at Baseline: Yes | Participants | 229 | 233 | 462 |
| Supplemental Oxygen at Baseline: No | Participants | 1 | 0 | 1 |
| Supplemental Oxygen at Baseline: Missing | Participants | 7 | 5 | 12 |
| Oxygen type (for supplemental oxygen at baseline - Yes): Intubation/Mechanical ventilation | Participants | 1 | 2 | 3 |
| Oxygen type (for supplemental oxygen at baseline - Yes): Low Flow Nasal Cannulas (LFNC) | Participants | 3 | 1 | 4 |
| Oxygen type (for supplemental oxygen at baseline - Yes): Non-invasive ventilation/High Flow Nasal Cannulas (HFNC)/Mask with reservoir/Mask w | Participants | 225 | 230 | 455 |
| Oxygen flow at baseline (L/min) | L/min | 24.6 (SD 19.59) | 24.9 (SD 19.83) | 24.8 (SD 19.69) |
| Oxygen in the gas mix (%) | Percentage of oxygen | 65.5 (SD 60.0) | 64.1 (SD 60.0) | 64.8 (SD 60.0) |
| Median percentage of oxygen in the gas mix (%) | Percentage of oxygen | 60.0 (25 to 100) | 60.0 (30 to 100) | 60.0 (25 to 100) |
| FiO2≤60% sub-population inflammation markers: lymphocyte counts | 10^9*cell/L | 0.910 (0.69 to 1.36) | 1.010 (0.72 to 1.41) | 0.990 (0.71 to 1.38) |
| FiO2≤60% sub-population inflammation markers: CRP Levels | mg/L | 67.100 (26.77 to 173.00) | 45.00 (18.60 to 145.60) | 60.80 (21.40 to 153.40) |
6. Primary Endpoint
The registry lists the primary outcome as Supplemental Oxygen Requirement, measured over 14 days maintained up to 42 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint asks whether a participant no longer required supplemental oxygen for at least 24 hours by Day 14, with that status maintained up to Day 42. The endpoint is expressed as a proportion and compares subjects taking opaganib with subjects receiving placebo. Its analysis population is the modified ITT population, defined in the registry as randomized subjects who received at least one dose of study medication.
In general, an oxygen-support endpoint captures a clinically observable aspect of respiratory status and use of supportive care. Requiring a period without supplemental oxygen helps distinguish a sustained change from a brief interruption in support. Assessment beyond the initial threshold can also describe whether the status persisted over the stated follow-up. These are general reasons such endpoints may be selected; the registry record does not state the rationale used by the study designers.
Interpreting a proportion requires knowing both how many participants met the criterion and the denominator used in each group. A treatment comparison is more informative when accompanied by an effect estimate and a confidence interval, which describes the range of values compatible with the data under the analysis assumptions. The primary endpoint has several categories or time points and is not reduced to one comparison in the posted results represented in the registry record. A numerical effect estimate, confidence interval, and corresponding test result are not reported in the registry record, so the magnitude and precision of the primary comparison cannot be described.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a randomized comparison of opaganib plus standard of care against placebo plus standard of care. It also defines the primary question: the proportion no longer requiring supplemental oxygen for at least 24 hours by Day 14, maintained up to Day 42, in the modified ITT population. Those details define what a primary comparison would mean. They do not, by themselves, establish the direction or size of any observed difference.
The available record does not give a single primary-outcome comparison. It characterizes the primary outcome as having several categories or time points and does not reduce it to one comparison. Numerical group results, a between-group effect estimate, a confidence interval, and a p-value for the primary endpoint are not reported in the registry record. Consequently, no conclusion about which group had a higher proportion meeting the criterion, or how precisely any difference was estimated, can be drawn from these registry entries.
The adverse-event information is descriptive. The registry lists 52 participants affected by serious adverse events in each group, with 230 at risk in the opaganib group and 233 at risk in the placebo group. It lists 155 affected by other adverse events in the opaganib group and 147 in the placebo group. Death counts are 44 and 47, respectively. These counts do not establish that an event was caused by study medication. The record does not provide enough detail to interpret event timing, severity beyond the serious classification, attribution, or statistical uncertainty around group differences.
In general, a difference in observed counts should not be read as a treatment effect without considering the population at risk, follow-up, event definitions, and the analysis plan. A confidence interval would help show the uncertainty around a comparative estimate. The registry entries do not report such intervals for the primary endpoint or the adverse-event counts. Nor do they report a statistical test for these safety comparisons.
The study is marked completed, but completion status is not itself an efficacy result. Likewise, the recorded enrollment and the presence of a phase 2/3 designation do not indicate whether the primary objective was met. The registry entries support a description of design, endpoint, and selected safety counts; they do not support a claim that opaganib improved, worsened, or had no effect on the primary outcome.
9. Statistical Methods Explained
Several statistical ideas help clarify what can and cannot be inferred from the registry record. The distinction between the study design, the outcome definition, and the estimated result is important: a well-defined comparison is not the same as a reported comparison, and neither alone demonstrates a treatment effect.
What does randomization contribute?
In general, randomization assigns participants to groups by chance. Its purpose is to reduce systematic differences in prognosis between groups, including differences that may not have been measured. It does not guarantee that groups will be identical, and it does not remove uncertainty from the results. In this study, the record says allocation was randomized and the design was parallel. The precise randomization method and any stratification factors are not reported in the registry record.
Blinding can reduce the chance that expectations influence care or outcome assessment. The record lists quadruple masking, but does not define the roles covered by that designation or report whether masking was assessed. The design label therefore describes the intended masking arrangement without establishing how it operated in practice.
What does the primary endpoint measure?
The primary endpoint is framed as a proportion: subjects who meet the oxygen criterion relative to the relevant analysis population. The criterion is no longer requiring supplemental oxygen for at least 24 hours by Day 14, maintained up to Day 42. In general, proportions communicate how common an outcome is within a defined group. A comparison between groups should retain the denominator and population definition, because counts alone can be misleading when group sizes or available follow-up differ.
The registry defines the primary analysis population as modified ITT: randomized subjects who received at least one dose. In general, an analysis population is part of the estimand—the precise treatment effect a study aims to describe. The modified ITT definition excludes randomized subjects who did not receive a dose, while retaining those who received at least one dose. The record does not report how participants with missing endpoint data were handled or whether additional analysis populations were used.
How should an effect estimate be read?
In general, an effect estimate expresses the size and direction of a comparison. For a proportion outcome, an analysis might report group proportions and a difference or another specified contrast. The contrast needs a clear definition: a positive value can mean different things depending on which group is subtracted from which. The registry entries do not report a primary effect estimate or specify a contrast for the primary comparison.
A confidence interval describes uncertainty in an estimate under the model and sampling assumptions used. A narrower interval generally indicates greater precision, while a wider interval indicates more uncertainty. An interval that includes values consistent with no difference does not prove the groups are identical; it indicates that the data do not precisely distinguish those possibilities under the stated analysis. No primary-endpoint confidence interval is reported in the registry record.
A p-value, when reported, summarizes how compatible the observed data are with a specified null model under its assumptions. It is not the probability that the null hypothesis is true, nor does it measure clinical importance. The registry entries do not report a primary p-value, a threshold for statistical significance, or the statistical test used for the primary comparison. No interpretation of statistical significance is therefore possible from these registry entries.
Why do multiple outcomes and time points matter?
The registry lists 23 outcome measures and 19 analyses. Multiple outcomes or assessment times create multiple opportunities to observe apparently unusual results by chance. In general, multiplicity procedures may adjust how evidence is evaluated across a family of comparisons, or the analysis plan may designate a hierarchy of outcomes. Which approach was used can affect interpretation. Multiplicity handling and the prespecified hierarchy are not reported in the registry record.
The primary outcome is specifically noted as having several categories or time points and is not reduced to one comparison. A single summary can sometimes obscure variation across categories or assessments, while separate comparisons can increase multiplicity concerns. Without the outcome-level estimates, analysis choices, and multiplicity plan, neither the pattern across assessments nor the strength of evidence can be reconstructed.
What can planning illustrations say?
In general, sample-size planning uses assumptions about the outcome, the effect worth detecting, variability, allocation, and the desired operating characteristics of a future study. Planning illustrations based on an observed effect are not the same as the original design calculation, and they are not observed power. The stated assumptions for the illustrations include a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is described as a fraction of the observed effect. The record explicitly characterizes these calculations as planning illustrations, not the trial's own design. The trial's sample-size justification and original design assumptions are not reported in the registry record.
For binary outcomes, general planning methods depend on event proportions and a specified comparison. For time-to-event outcomes, planning may instead focus on event counts. These are general distinctions, not claims about a model used for this primary endpoint. The record does not report enough detail to reproduce or evaluate a primary-outcome calculation.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 23 outcome measures and 19 analyses, including secondary outcomes covering clinical status, oxygen support, discharge, ventilation, viral swabs, and mortality. Considering many outcomes or assessment times can increase the chance that at least one result appears notable by chance. In general, statistical plans address this through a prespecified hierarchy, adjustment, or a clearly defined distinction between confirmatory and exploratory analyses. The multiplicity strategy and hierarchy are not reported in the registry record.
The primary endpoint includes several categories or time points and is not reduced to one comparison in the posted results represented in the record. The record does not provide a single primary estimate, its confidence interval, or a p-value. The statistical test or model used, and any planned handling of repeated assessments, are not reported in the registry record.
The primary population is the modified ITT population, defined as randomized subjects who received at least one dose. This definition is reported, but the handling of missing endpoint measurements, withdrawals, and participants without an assessment at a relevant time point is not reported in the registry record. The record also does not say whether sensitivity analyses were used to examine the consequences of missing data.
These omissions matter because missing observations and multiple comparisons can affect the interpretation of results. In general, missingness may be related to a participant's health status, and different assumptions or methods can lead to different estimates. No particular missing-data mechanism or method should be assumed for this study. Without the statistical plan and analysis details, the robustness of the primary comparison and the role of secondary results cannot be evaluated from 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 |
|---|---|---|---|
| Opaganib | 52 | 230 | 22.6% |
| Placebo | 52 | 233 | 22.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Opaganib | 44 of 230 |
| Placebo | 47 of 233 |
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 |
|---|---|
| Opaganib | 155 of 230 |
| Placebo | 147 of 233 |
Most frequent serious adverse event terms
| Event term | Organ system | Opaganib | Placebo |
|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 18 of 230 | 16 of 233 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 10 of 230 | 13 of 233 |
| Pneumonia | Infections and infestations | 10 of 230 | 6 of 233 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 7 of 230 | 5 of 233 |
| Septic shock | Infections and infestations | 5 of 230 | 6 of 233 |
| Sepsis | Infections and infestations | 2 of 230 | 7 of 233 |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 2 of 230 | 5 of 233 |
| Renal impairment | Renal and urinary disorders | 2 of 230 | 4 of 233 |
| Acute kidney injury | Renal and urinary disorders | 4 of 230 | 1 of 233 |
| COVID-19 pneumonia | Infections and infestations | 1 of 230 | 2 of 233 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Opaganib | Placebo |
|---|---|---|---|
| Constipation | Gastrointestinal disorders | 22 of 230 | 24 of 233 |
| Alanine aminotransferase increased | Investigations | 12 of 230 | 14 of 233 |
| Insomnia | Psychiatric disorders | 17 of 230 | 9 of 233 |
| Hyperkalaemia | Metabolism and nutrition disorders | 9 of 230 | 8 of 233 |
| Nausea | Gastrointestinal disorders | 12 of 230 | 3 of 233 |
| Tachycardia | Cardiac disorders | 4 of 230 | 11 of 233 |
| Hypotension | Vascular disorders | 7 of 230 | 6 of 233 |
| Diarrhoea | Gastrointestinal disorders | 6 of 230 | 6 of 233 |
| Headache | Nervous system disorders | 8 of 230 | 4 of 233 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 6 of 230 | 6 of 233 |
Serious events with the highest arm-level rate: respiratory failure (7.8%), acute respiratory failure (5.6%), pneumonia (4.3%), pulmonary embolism (3.0%), sepsis (3.0%).
The registry reports serious adverse-event counts among participants at risk: 52 affected in the opaganib group, with 230 at risk, and 52 affected in the placebo group, with 233 at risk. For other adverse events, it lists 155 affected in the opaganib group and 147 in the placebo group. The recorded death counts are 44 for opaganib and 47 for placebo. These are descriptive counts; they are not, by themselves, estimates of a causal treatment effect.
The record also lists serious adverse-event terms with percentages: respiratory failure, 7.8%; acute respiratory failure, 5.6%; pneumonia, 4.3%; pulmonary embolism, 3.0%; sepsis, 3.0%; and septic shock, 2.6%. The registry entries do not specify the denominator or clarify whether these percentages refer to participants, events, or another reporting basis. They should therefore be read as reported values, not converted into a comparative risk.
In general, safety interpretation depends on consistent definitions, observation time, event attribution, and the population included. The registry record does not report the event-level timing, adjudication details, or statistical uncertainty for these counts. A count does not establish that an event was caused by study medication, and a difference in counts does not establish a treatment effect.
12. What the Result Does, and Does Not, Mean
The record describes a randomized, double-blind, placebo-controlled comparison of opaganib plus standard of care with matching placebo plus standard of care in adults hospitalized with severe SARS-CoV-2 positive pneumonia. It identifies supplemental oxygen requirement as the primary outcome and defines the population for that outcome. It also reports selected safety counts and lists a range of secondary outcomes. These details explain what the study set out to assess and what kinds of observations the registry records.
The record does not report a single primary-outcome comparison. It gives no numerical group results, effect estimate, confidence interval, or p-value for the primary endpoint in the registry record for this analysis. Therefore, the posted information does not establish whether the groups differed in the proportion meeting the oxygen criterion, or how precisely a difference was estimated. It also does not establish equivalence or absence of an effect.
The safety counts can be described as recorded, but they do not alone show whether opaganib caused or prevented an event. Interpreting them comparatively would require the event definitions, follow-up details, analysis methods, and uncertainty around the estimates. The serious adverse-event terms and percentages are listed, but their percentage denominator is not reported in the registry record.
In general, a trial result is strongest when the endpoint, analysis population, effect measure, uncertainty, and statistical plan can be considered together. Here, the endpoint and modified ITT definition are described, but key results and methods are not reported in the registry record. Completion status, study phase, or enrollment does not substitute for those results. The appropriate reading is limited to the design and descriptive information actually recorded, without drawing an efficacy conclusion.
13. Why This Trial Matters Statistically
This study raises several statistical issues relevant to clinical trials. Its randomized, parallel-group design creates a direct comparison between opaganib and matching placebo, both alongside standard of care. The primary endpoint focuses on oxygen support, a clinical status measure, and specifies both an early assessment and maintenance of the status up to Day 42. The population is also explicitly defined as modified ITT rather than simply all randomized subjects.
Those details matter because an outcome's meaning depends on its operational definition and analysis population. A sustained oxygen-status criterion is not interchangeable with a one-time assessment, and a proportion requires a clear denominator. In general, reporting the group results alongside a defined contrast and confidence interval would show both the direction and precision of the estimate. The primary comparison is not reported as a single estimate in the registry record, so those interpretations cannot be made from the registry entries.
The record's many listed outcome measures and analyses also illustrate why multiplicity is important. A trial can examine several aspects of clinical status, care, and laboratory findings, but interpretation depends on which outcomes were prespecified as confirmatory and how repeated testing was addressed. That strategy is not reported in the registry record. Likewise, the modified ITT definition is stated, while missing-data handling is not.
Safety reporting adds another important distinction: counts of affected participants, deaths, and serious event terms are descriptive unless their definitions, denominators, follow-up, and comparative uncertainty are clear. These considerations are broadly applicable when reading registry results. For this study, they limit conclusions to the stated design and recorded safety information rather than a claim about the primary outcome.
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 limitation for interpretation is that the primary outcome is not reported as a single comparison. The registry identifies the oxygen-requirement criterion and the modified ITT population, but the numerical group results, effect estimate, confidence interval, and p-value are not reported in the registry record. The magnitude, direction, and precision of the primary result therefore cannot be assessed.
The registry lists multiple outcome measures and analyses, but the multiplicity strategy and outcome hierarchy are not reported. The statistical test or model for the primary endpoint is also not reported. Although the primary population is defined, the handling of missing endpoint data, withdrawals, and sensitivity analyses is not reported in the registry record.
Safety information is limited to selected counts and serious-event terms. The record does not provide the event timing, attribution, adjudication details, or uncertainty needed for a detailed comparative assessment. The denominator and reporting basis for the listed serious-event percentages are not specified in the registry entries.
The study is described as randomized, double-blind, parallel, and quadruple-masked, but the randomization procedure, masking roles, and assessment of masking are not reported. The original sample-size justification and statistical plan are also not reported in the registry record. These limitations do not establish that the study was poorly conducted; they mark what cannot be evaluated from the available registry information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia — NCT04467840.
- Registry record last updated 2025-07-31; status last verified 2025-07.
- Results first posted 2023-10-19.
- 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 NCT04467840, a completed randomized, double-blind, parallel-group phase 2/3 study of opaganib plus standard of care versus matching placebo plus standard of care. It enrolled adults hospitalized with severe SARS-CoV-2 positive pneumonia and lists enrollment of 475. The recorded start date is 2020-08-21, and the primary completion date is 2021-07-18. The sponsor is RedHill Biopharma Limited.
The primary endpoint concerns no longer requiring supplemental oxygen for at least 24 hours by Day 14, maintained up to Day 42, in randomized subjects who received at least one dose. The registry also lists secondary outcomes involving clinical status, oxygen support, discharge, ventilation, viral swabs, and mortality.
Selected adverse-event counts and serious-event terms are recorded. A single primary-outcome comparison, its estimate and uncertainty, the multiplicity strategy, and missing-data methods are not reported in the registry record. The registry entries describe the study design and selected safety information but do not support an efficacy conclusion.