Engchem Life Sciences Receives US FDA Approval for Phase 2 Clinical Trial Plan of COVID-19
[Asia Economy Reporter Oh Ju-yeon] Engchem Life Sciences announced on the 7th that it has received approval from the U.S. Food and Drug Administration (FDA) for its clinical phase 2 trial plan (IND) to evaluate the safety and efficacy of EC-18 in preventing the progression from pneumonia to acute respiratory failure or acute respiratory distress syndrome in patients infected with the novel coronavirus disease (COVID-19).
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The clinical trial will involve 60 patients with infectious pneumonia caused by COVID-19 (up to 30 patients per group) and will last for a total of 28 days. EC-18 or a placebo will be administered orally once daily at 2000 mg alongside standard treatment, and efficacy and safety will be evaluated.
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