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NCT04414618 · ClinicalTrials.gov registry record · Phase 2
A Study of Opaganib in Coronavirus Disease 2019 Pneumonia
A Phase 2 study, sponsored by RedHill Biopharma Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT04414618: Completed Phase 2 study, sponsored by RedHill Biopharma Limited.
NCT04414618 is a Phase 2 study that has completed, run by RedHill Biopharma Limited. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04414618, a Phase 2 study, has completed, sponsored by RedHill Biopharma Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
This proof of concept study will take place in the US and other countries in approximately 15 clinical sites and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. 20 patients will receive opaganib in addition to standard of care twice each day for 14 days. 20 will receive matching placebo in addition to standard of care unless the patient has been discharged from the hospital without requiring supplemental oxygen, in which case study drug will only be administered for 10 days. All participants will be followed up for 4 weeks after their last dose of study drug.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Opaganib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-07-02 |
| Est. Completion | 2020-12-23 |
| Phase | Phase 2 |
What the finished NCT04414618 record still lists
NCT04414618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04414618 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04414618 about?
NCT04414618 is a clinical study titled "A Study of Opaganib in Coronavirus Disease 2019 Pneumonia". This proof of concept study will take place in the US and other countries in approximately 15 clinical sites and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. 20 patients will receive opaganib in addition to...
What is the current status of trial NCT04414618?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2020-07-02. Estimated completion is 2020-12-23.
What interventions are being tested in trial NCT04414618?
The interventions under investigation include: Placebo (DRUG), Opaganib (DRUG).
Who is sponsoring clinical trial NCT04414618?
This trial is sponsored by RedHill Biopharma Limited, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04414618's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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