Trial · NCT04467840

Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia

NCT04467840, Phase 2, Phase 3, Completed, RedHill Biopharma Limited; results first posted 2023-10-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia. Trials, record NCT04467840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04467840

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia
NCT number: NCT04467840
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 475 participants, actual
Lead sponsor: RedHill Biopharma Limited
Conditions: COVID-19, Lung Infection
Interventions: Opaganib, Placebo
First posted: 2020-07-13
Last updated: 2025-07-31
Results first posted: 2023-10-19

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Supplemental Oxygen Requirement	14 days maintained up to 42 days	To compare the proportion of patients no longer requiring supplemental oxygen for at least 24 hours by Day 14 between subjects taking opaganib and those on placebo.
Secondary	Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42	14 days maintained up to 42 days	Compare ≥2 category improvement on the WHO Ordinal Scale for Clinical Improvement from 0(uninfected) to 8(death) for subjects taking opaganib and those on placebo, lower scores indicate improvement. Success was defined as subject who reached improvement of at least two points on the WHO Ordinal Scale by Day 14, maintained by the end of study visit, and failure otherwise.
Secondary	Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement With a Scale Ranging From 8 Down to 0	14 days maintained up to 42 days	Compare scores of subjects taking opaganib and those on placebo, lower scores indicate improvement to determine time to recovery as defined by improvement to a score of 3 or less on the WHO Ordinal Scale for Clinical Improvement with a scale ranging from 0 (uninfected) to 8 (death)
Secondary	Number of Participants With Low Oxygen Flow Via Nasal Cannula	14 days maintained up to 42 days	To compare the time to low oxygen flow via nasal cannula e.g. from high oxygen flow via nasal cannula or CPAP, if high oxygen flow is not an available option between subjects taking opaganib and those on placebo.
Secondary	Time to Discharge From Hospital Measured at 14 Days	14 days	Time to subject discharge from hospital
Secondary	Patients Requiring Intubation and Mechanical Ventilation by Day 42	42 days	To compare the proportion of patients requiring intubation and mechanical ventilation between subjects taking opaganib and those on placebo.
Secondary	Number of Patients With Two Consecutive Negative Swabs for SARS-CoV-2 at Day 14	14 days	To compare the number of patients with two consecutive negative swabs for SARS-CoV-2 by PCR at Day 14 between subjects taking opaganib and those on placebo.
Secondary	Patients With Negative Swabs for SARS-CoV-2 at Day 14	14 days	To compare the proportion of patients with two consecutive negative swabs for SARS-CoV-2 by PCR at Day 14 between subjects taking opaganib and those on placebo.
Secondary	Mortality Due to Any Cause	28 days	To compare mortality 28 days post-baseline between subjects taking opaganib and those taking placebo
Secondary	Mortality Due to Any Cause	42 days	To compare mortality 42 days post-baseline between subjects taking opaganib and those taking placebo

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes23

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Supplemental Oxygen Requirement	14 days maintained up to 42 days	Modified ITT (mITT) population defined as randomized subjects who received at least one dose of study medication	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42	14 days maintained up to 42 days	mITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement With a Scale Ranging From 8 Down to 0	14 days maintained up to 42 days	mITT population presenting subjects who experienced a recovery event by Day 14 maintained up to day 42	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Low Oxygen Flow Via Nasal Cannula	14 days maintained up to 42 days	mITT. In this analysis, subjects who required low-flow supplemental oxygen at Day 1 (baseline) were considered success events, and the time to event of interest for these subjects was defined as 0.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Discharge From Hospital Measured at 14 Days	14 days	mITT	Days	MEDIAN
SECONDARY	Patients Requiring Intubation and Mechanical Ventilation by Day 42	42 days	Subjects requiring intubation by Day 42	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Two Consecutive Negative Swabs for SARS-CoV-2 at Day 14	14 days	Only subjects who were positive for SARS-CoV-2 by PCR at the screening visit were analyzed	participants	NUMBER
SECONDARY	Patients With Negative Swabs for SARS-CoV-2 at Day 14	14 days	Only subjects who were positive for SARS-CoV-2 by PCR at the screening visit AND had at least two post baseline PCR tests were analyzed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mortality Due to Any Cause	28 days	Mortality (failure) was assessed by treatment Day 28 (including). Any early termination/ missing survival status at the end of study visit was also regarded as failure for the primary analysis of this endpoint.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mortality Due to Any Cause	42 days	Mortality (failure) was assessed by treatment Day 42 (including). Any early termination/ missing survival status at the end of study visit was also regarded as failure for the primary analysis of this endpoint.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 23Source ClinicalTrials.gov

See all 23 outcomes

Results by group134

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Supplemental Oxygen Requirement	Opaganib	Subjects not receiving supplemental oxygen for at least 24 hours by Day 14 and maintained at Day 42	139	Participants
Supplemental Oxygen Requirement	Placebo	Subjects not receiving supplemental oxygen for at least 24 hours by Day 14 and maintained at Day 42	132	Participants
Supplemental Oxygen Requirement	Opaganib	Subjects receiving supplemental oxygen (including: death, lost to follow-up, or need of oxygen)	91	Participants
Supplemental Oxygen Requirement	Placebo	Subjects receiving supplemental oxygen (including: death, lost to follow-up, or need of oxygen)	101	Participants
Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42	Opaganib	Subject has improvement > or equal to 2 on the WHO Ordinal Scale Day 14 and up to to Day 42	145	Participants
Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42	Placebo	Subject has improvement > or equal to 2 on the WHO Ordinal Scale Day 14 and up to to Day 42	138	Participants
Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42	Opaganib	Subject has improvement of 1 or none on the WHO Ordinal Scale (Failure) Day 14 up to Day 42	85	Participants
Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42	Placebo	Subject has improvement of 1 or none on the WHO Ordinal Scale (Failure) Day 14 up to Day 42	95	Participants
Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42	Opaganib	Failure due to not achieving improvement at Day 14	64	Participants
Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42	Placebo	Failure due to not achieving improvement at Day 14	69	Participants

1 to 10 of 134Source ClinicalTrials.gov

See all 134 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Opaganib	237
Overall Study	STARTED	Placebo	238
Overall Study	mITT Population	Opaganib	230
Overall Study	mITT Population	Placebo	233
Overall Study	COMPLETED	Opaganib	186
Overall Study	COMPLETED	Placebo	186
Overall Study	NOT COMPLETED	Opaganib	51
Overall Study	NOT COMPLETED	Placebo	52

Source ClinicalTrials.gov

Adverse events584

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	Opaganib	2	230	2
other	Abdominal pain	Gastrointestinal disorders	Placebo	2	233	2
other	Abdominal pain upper	Gastrointestinal disorders	Opaganib	3	230	3
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	1	233	1
other	Abdominal wall haematoma	Gastrointestinal disorders	Opaganib	2	230	2
other	Abdominal wall haematoma	Gastrointestinal disorders	Placebo	1	233	1
other	Abscess limb	Infections and infestations	Opaganib	1	230	1
other	Abscess limb	Infections and infestations	Placebo	0	233	0
other	Acute kidney injury	Renal and urinary disorders	Opaganib	3	230	4
other	Acute kidney injury	Renal and urinary disorders	Placebo	3	233	3

1 to 10 of 584Source ClinicalTrials.gov

See all 584 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Opaganib	44	230
Total, all-cause mortality	Placebo	47	233
Total, other adverse events	Opaganib	155	230
Total, other adverse events	Placebo	147	233
Total, serious adverse events	Opaganib	52	230
Total, serious adverse events	Placebo	52	233

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons9

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
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
Opaganib vs Placebo: Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement With a Scale Ranging From 8 Down to 0	Trial comparisons
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
Opaganib vs Placebo: Number of Subjects Discharged From Hospital in the FiO2 > 60% Population	Trial comparisons
Opaganib vs Placebo: Number of Subjects Discharged From Hospital in the FiO2 ≤60% Population	Trial comparisons
Opaganib vs Placebo: Number of Participants With Low Oxygen Flow Via Nasal Cannula	Trial comparisons
Opaganib vs Placebo: Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Trial comparisons
Opaganib vs Placebo: deaths from any cause	Trial comparisons
Opaganib vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04467840

GET https://conductscience.org/api/trials/v1/NCT04467840/outcomes?page=2

API reference For AI assistants