Trial · NCT04414618
A Study of Opaganib in Coronavirus Disease 2019 Pneumonia
NCT04414618, Phase 2, Completed, RedHill Biopharma Limited; results first posted 2022-03-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Opaganib in Coronavirus Disease 2019 Pneumonia. Trials, record NCT04414618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04414618
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Opaganib in Coronavirus Disease 2019 Pneumonia
- NCT number
- NCT04414618
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- RedHill Biopharma Limited
- Conditions
- Coronavirus Infections
- Interventions
- Opaganib, Placebo
- First posted
- 2020-06-04
- Last updated
- 2022-03-21
- Results first posted
- 2022-03-21
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measurement of the Change in Oxygen Requirement From Baseline | 14 days | Maximal oxygen flow (L/min) was recorded daily for the 14 days of treatment for each participant. Participant individual area under the curve (AUC) was calculated based on the trapezoidal rule, after subtracting the baseline oxygen requirement at each day. The median AUC absolute change from baseline (L/min) for each treatment arm is presented. |
| Secondary | Measurement of Time to the Reduction in Oxygen Requirement. | 14 days | The time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min. |
| Secondary | The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14 | 14 days | The percentage of subjects in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14. |
| Secondary | Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment | 6 weeks | The time in each arm to two consecutive negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab, at least 24 hrs. apart. |
| Secondary | The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14 | 14 days | The percentage of subjects in each arm to achieve two consecutive negative PCR nasopharyngeal or oropharyngeal swabs for SARS-CoV-2 at Day 14, at least 24 hrs. apart. |
| Secondary | Intubation and Mechanical Ventilation Requirements | From screening phase and every day from day 1 to day 14 of treatment | The percentage of patients in each arm who require intubation and mechanical ventilation by Day 14 |
| Secondary | Evaluation of the Time to Intubation and Mechanical Ventilation | From screening phase and every day from day 1 to day 14 of treatment | The time in each arm for the patient to require mechanical ventilation. |
| Secondary | Evaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14 | From screening phase and every day from day 1 to day 14 of treatment | The proportion of patients in each arm, with at least one measurement of fever at baseline (defined as temperature \>38.0 C\[100.4 F\]), who are afebrile (defined as temperature \<37.2C \[99 F\]) at Day 14 |
| Secondary | Evaluation of Mortality 30 Days Post-baseline | 30 days after day 1 of treatment | The mortality in each arm 30 days post-baseline. |
| Other | Safety TEAEs | 6 weeks | The number of subjects with treatment-emergent adverse events in each arm of all treatment-emergent adverse events (TEAEs). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Measurement of the Change in Oxygen Requirement From Baseline | 14 days | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). | L/min*day | MEDIAN |
| SECONDARY | Measurement of Time to the Reduction in Oxygen Requirement. | 14 days | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, one subject who did not have supplemental oxygen requirement at randomization was excluded from this analysis. | Days | MEDIAN |
| SECONDARY | The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14 | 14 days | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment | 6 weeks | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, as most subjects had been discharged by Day 7 and as the study was not designed to be performed on an outpatient basis, data was not available from enough subjects to perform these analyses. | Days | MEDIAN |
| SECONDARY | The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14 | 14 days | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, as most subjects had been discharged by Day 7 and as the study was not designed to be performed on an outpatient basis, data was not available from enough subjects to perform these analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Intubation and Mechanical Ventilation Requirements | From screening phase and every day from day 1 to day 14 of treatment | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Evaluation of the Time to Intubation and Mechanical Ventilation | From screening phase and every day from day 1 to day 14 of treatment | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). | Days | MEDIAN |
| SECONDARY | Evaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14 | From screening phase and every day from day 1 to day 14 of treatment | Patients in the Modified ITT (mITT) population (randomized and treated with at least one dose of study medication) with at least one measurement of fever at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Evaluation of Mortality 30 Days Post-baseline | 30 days after day 1 of treatment | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Safety TEAEs | 6 weeks | Safety population includes all subjects randomized and treated with at least one dose of study medication. One subject randomized to receive placebo, was mistakenly given 2 doses of opaganib and is therefore included twice. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Measurement of the Change in Oxygen Requirement From Baseline | Opaganib | -38.8 | 95% Confidence Interval -56.5 to 0 | L/min*day | |
| Measurement of the Change in Oxygen Requirement From Baseline | Placebo | -33.0 | 95% Confidence Interval -149.5 to -12.5 | L/min*day | |
| Measurement of Time to the Reduction in Oxygen Requirement. | Opaganib | 5.00 | 95% Confidence Interval 4.00 to 12.00 | Days | |
| Measurement of Time to the Reduction in Oxygen Requirement. | Placebo | 8.00 | 95% Confidence Interval 4.00 to NA | Days | |
| The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14 | Opaganib | 11 | Participants | ||
| The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14 | Placebo | 4 | Participants | ||
| Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment | Opaganib | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment | Placebo | NA | 95% Confidence Interval NA to NA | Days | |
| The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14 | Opaganib | NA | Participants | ||
| The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14 | Placebo | NA | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Opaganib | 23 | |
| Overall Study | STARTED | Placebo | 19 | |
| Overall Study | COMPLETED | Opaganib | 15 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Opaganib | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
Source ClinicalTrials.gov
Adverse events96
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 distension | Gastrointestinal disorders | Opaganib | 0 | 23 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 1 | 18 | |
| other | Abdominal wall wound | Injury, poisoning and procedural complications | Opaganib | 0 | 23 | |
| other | Abdominal wall wound | Injury, poisoning and procedural complications | Placebo | 1 | 18 | |
| other | Anemia | Blood and lymphatic system disorders | Opaganib | 1 | 23 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo | 1 | 18 | |
| other | Anxiety | Psychiatric disorders | Opaganib | 0 | 23 | |
| other | Anxiety | Psychiatric disorders | Placebo | 1 | 18 | |
| other | Blood calcium decreased | Investigations | Opaganib | 0 | 23 | |
| other | Blood calcium decreased | Investigations | Placebo | 1 | 18 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Opaganib | 3 | 23 |
| Total, all-cause mortality | Placebo | 3 | 18 |
| Total, other adverse events | Opaganib | 11 | 23 |
| Total, other adverse events | Placebo | 9 | 18 |
| Total, serious adverse events | Opaganib | 3 | 23 |
| Total, serious adverse events | Placebo | 5 | 18 |
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Opaganib vs Placebo: Intubation and Mechanical Ventilation Requirements | Trial comparisons |
| Opaganib vs Placebo: Evaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14 | Trial comparisons |
| Opaganib vs Placebo: Safety SAEs | Trial comparisons |
| Opaganib vs Placebo: The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14 | Trial comparisons |
| Opaganib vs Placebo: Safety TEAEs | Trial comparisons |
| Opaganib vs Placebo: deaths from any cause | Trial comparisons |
| Opaganib vs Placebo: Evaluation of Mortality 30 Days Post-baseline | 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.
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/NCT04414618
GET https://conductscience.org/api/trials/v1/NCT04414618/results?page=2