drugset / Trial / NCT04414618

A Study of Opaganib in Coronavirus Disease 2019 Pneumonia

NCT04414618

Phase 2 Completed 42 enrolled RedHill Biopharma Limited
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-07-02
Primary completion
2020-11-26
Completion
2020-12-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator ABC294640 Small molecule 500 mg