CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 475 enrolled
Drug / intervention
Opaganib +1 moredrug
Likely dose
Opaganib 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04467840
NCT04467840Phase 3Completed
CompareCT.gov

Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2/3 Study, in Adult Subjects Hospitalized With Severe SARS-CoV-2 Positive Pneumonia

RedHill Biopharma Limited·interventional·Posted Jul 13, 2020·Updated Jul 31, 2025

In Brief

A Phase 3 clinical trial evaluating Opaganib and Placebo for COVID-19 and Lung Infection. Completed, enrolled 475 participants across 57 sites in 10 countries.

Detailed Summary

A phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study in Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia to determine the potential of opaganib to improve and/or stabilize the clinical status of the patient.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19, Lung Infection
CountriesBrazil, Colombia, Israel, Italy, Mexico, Peru, Poland, Russia, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJul 13, 2020
Enrollment StartAug 21, 2020
Primary CompletionJul 18, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.0 years ago

Interventions

Opaganibdrug

Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14).

Placebodrug

Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14).