RedHill Bipharma has initiated a global phase 2/3 study in order to evaluate the use of opaganib in patients with severe COVID-19.
Opaganib is believed to have potential against COVID-19 due to of a combination of anti-inflammatory and anti-viral activity. The medication is not yet approved or authorized.
Emergency use applications are planned for submission within the year, pending positive results.
The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study will focus on 270 patients with pneumonia requiring treatment with supplemental oxygen across 40 clinical sites.
Clinical sites include countries in Europe and Latin America.
Participants in the study will be randomized 1:1 to receive placebo or opaganib, with both groups receiving standard-of-care therapy against COVID-19.
According to authors of the announcement, the primary endpoint of the study is to evaluate whether the drug has an impact on whether patients receiving standard of care are less likely to require intubation and mechanical ventilation by Day 14 with opaganib added.
An independent data safety monitoring board will review findings during the study.
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