| Abstrakt: |
배경 Pyramax, a fixed dose combination of pyronaridine tetraphosphate and artesunate (180/60 mg) has been initially approved for acute, uncomplicated malaria. Given its ready availability, proven clinical safety and tolerability, and the recent new non-clinical efficacy findings against SARS-CoV-2 wild-type and delta variant, the repurposing of Pyramax offers a fast-translational option to fulfil the current unmet need for globally accessible, earlier treatment of mild-to-moderate COVID-19. 방법 In this Phase 2 study involving adult patients with mild-to-moderate COVID-19, we randomly assigned 113 patients to receive either one dose of Pyramax tablet or placebo once daily for 3 days and eval- uated the quantitative virologic and clinical outcomes. Safety was also evaluated. Patients were followed up to Day 28. 결과 Pyramax reduced viral load faster than placebo in high viral load carriers [patients with top 50% infectious viral load at baseline, ≥6000 (median) plaque-forming units (PFU)/ml]; the least-squares mean difference (Standard Error, SE) in changes of viable virus load from baseline (% change at Day 3) for Pyramax-treated patients was - 96.3 (31.5)% (95% confidence interval [CI], -160.1 to -32.5), significantly larger compared to the placebo-treated patients with -34.5 (30.7)% (95% CI, -96.7 to 27.7)(P=0.0143). In clinical outcomes, COVID-19 related hospitalization or death from any cause (≥24 hours of acute care) occurred in 5 of 52 patients (9.6%) in the Pyramax group and in 12 of 58 patients (20.7%) in the pla- cebo group through 28 days. Oxygen therapy due to worsening of symptoms occurred in 2 of 52 patients (3.8%) in the Pyramax group and in 5 of 58 patients (8.6%) in the Placebo group. The incidence of adverse events (AE) was not significantly different between groups. The most common AEs were nausea (13.5%), dyspepsia (11.5%), diarrhea (9.6%) and headache (5.8%), apart from pneumonia due to progression of the disease. There was no Suspected Unexpected Serious Adverse Reaction (SUSAR). 결론 Pyramax showed the tendency reducing the risk of COVID-19 related hospitalization/death and oxygen therapy. It reduced the SARS-CoV-2 infectious viral load more efficiently than placebo, suggesting a clinical benefit to warrant large-scale phase 3 studies including a currently ongoing global phase 3 study in 1420 patients. (Funded by Shin Poong Pharm. Co., Ltd; ClinicalTrials.gov number, NCT04475107) [ABSTRACT FROM AUTHOR] |
