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Safety and efficacy of Artemisinin-Piperaquine for treatment of COVID-19: an open-label, non-randomized, and controlled trial.
BACKGROUND: There are no effective therapies for patients with Coronavirus disease-2019 (COVID-19).
METHODS: Forty-one patients with confirmed COVID-19 were enrolled in the study and divided into two groups: artemisinin-piperaquine (AP) group (n=23) and control group (n=18). The primary outcome was the time taken to reach undetectable levels of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) and the percentage of participants with undetectable SARS-CoV-2 on day 7, 10, 14, and 28. The computed tomography (CT) imaging changes within ten days, the corrected QT interval changes, adverse events, and abnormal laboratory parameters were the secondary outcomes.
RESULTS: The mean time to reach undetectable viral RNA (mean± standard deviation) was 10.6±1.1 days (95% confidence interval [CI]: 8.4-12.8) for AP group and 19.3±2.1 days (95% CI: 15.1-23.5) for the control group. The percentage of patients with undetectable viral RNA on day 7, 10, 14, 21, and 28 were 26.1%, 43.5%, 78.3%, 100%, and 100%, respectively, in the AP group and 5.6%, 16.7%, 44.4%, 55.6% and 72.2%, respectively, in the control group. The CT imaging within ten days post-treatment showed no significant differences between the two groups (p>0.05). Both groups had mild adverse events.
CONCLUSIONS: In patients with mild to moderate COVID-19, the time to reach undetectable SARS-CoV-2 was significantly shorter in the AP group than that in the control group. However, physicians should consider the QT interval changes before using AP.
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