Comparison · NCT04467840-0d5dbff8
Opaganib vs Placebo: Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement in the FiO2 ≤60% Population
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Opaganib vs Placebo: Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement in the FiO2 ≤60% Population. Trial comparisons, record NCT04467840-0d5dbff8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04467840-0d5dbff8
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.795 | 0.713 | 0.858 | wilson | |
| Risk in group 2 | 0.657 | 0.573 | 0.732 | wilson | |
| Risk difference, group 1 minus group 2 | 0.138 | 0.027 | 0.243 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 1.04 | 1.41 | log | |
| Odds ratio, group 1 over group 2 | 2.03 | 1.14 | 3.59 | log | |
| Number needed to treat, for one more participant with the outcome on Opaganib than on Placebo | 7.24 | 4.11 | 37 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Opaganib | Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube. | 93 | 117 | OG000 |
| Group 2 | Placebo | Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube. | 88 | 134 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- POST_HOC
- Title
- Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement in the FiO2 ≤60% Population
- Description
Compare scores of subjects taking opaganib and those on placebo, lower scores indicate improvement.~WHO Ordinal Scale for Clinical Improvement with a scale ranging from 8 down to 0 with a higher score indicating a poorer clinical status
- Time frame
- 14 days
- Population
A post hoc analysis set comprised two sub-populations, namely, lower FiO2 (FiO2 at baseline ≤ the median of 60%) and higher FiO2 (FiO2 at baseline \> the median of 60%) was added after the final version of the SAP was signed.
Source ClinicalTrials.gov
Trial
- Title
- Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia
- NCT number
- NCT04467840
- Phases
- PHASE2, PHASE3
- Conditions
- COVID-19, Lung Infection
- Interventions
- Opaganib, Placebo
- Lead sponsor
- RedHill Biopharma Limited
- Results first posted
- 2023-10-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04467840?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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