The EUA was granted based on data from the phase 3 ACTT-2 trial, which was conducted by the NIAID.
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The FDA has approved the Investigational New Drug (IND) application for the phase 2a study of opaganib (RedHill Biopharma) in patients with confirmed moderate to severe SARS-CoV-2 infection.
The placebo-controlled ACTT 3 trial will evaluate the efficacy and safety of remdesivir in combination with interferon beta-1a in more than 1000 hospitalized COVID-19 patients.
The approval was based on data from the phase 3 ACTT-2 and COV-BARRIER studies.
The studies evaluated routine clinical practice data from more than 800 hospitals in the US.
Both randomized, placebo-controlled trials are expected to enroll approximately 1000 hospitalized patients.
Findings showed that the trial did not meet statistical significance on the primary endpoint.
The FDA approved Veklury (remdesivir; Gilead Sciences) for the treatment of COVID-19 in patients aged ≥12 years (weighing ≥40kg) requiring hospitalization.
Following clearance of an Investigational New Drug Application by the Food and Drug Administration, ViralClear announced that a phase 2 study evaluating merimepodib oral solution for the treatment of coronavirus disease 2019 (COVID-19) will be initiated.
The ACTT-2 study began on May 8 and included more than 1000 patients.