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Controlled Clinical Trial
. 2021 Jan;57(1):106216.
doi: 10.1016/j.ijantimicag.2020.106216. Epub 2020 Nov 2.

Safety and efficacy of artemisinin-piperaquine for treatment of COVID-19: an open-label, non-randomised and controlled trial

Guoming Li  1 , Mei Yuan  2 , Haihong Li  2 , Changsheng Deng  3 , Qi Wang  3 , Yexiao Tang  3 , Hongying Zhang  1 , Weisheng Yu  3 , Qin Xu  1 , Yuanyuan Zou  3 , Yueming Yuan  1 , Jiawen Guo  1 , Chunming Jin  2 , Xiangdong Guan  4 , Fengjie Xie  5 , Jianping Song  6
Affiliations
Controlled Clinical Trial

Safety and efficacy of artemisinin-piperaquine for treatment of COVID-19: an open-label, non-randomised and controlled trial

Guoming Li et al. Int J Antimicrob Agents. 2021 Jan.

Abstract

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) (n = 23) and control (n = 18). The primary outcome were 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 days 7, 10, 14, and 28. The computed tomography (CT) imaging changes within 10 days, 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 the AP group and 19.3 ± 2.1 days (95% CI 15.1-23.5) for the control group. The percentages of patients with undetectable viral RNA on days 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 10 days post-treatment showed no significant between-group differences (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 QT interval changes before using AP.

Keywords: Antimalarial; Artemisinin; COVID-19; Piperaquine; SARS-CoV-2.

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Figures

Figure 1
Figure 1
Study flowchart.
Figure 2
Figure 2
Kaplan-Meier curves for the time taken to achieve undetectable viral RNA levels in different treatment groups.
Figure 3
Figure 3
Overall time taken to achieve undetectable viral RNA levels in different treatment groups.
Figure 4
Figure 4
Electrocardiogram monitoring of the corrected QT interval change in the artemisinin-piperaquine group. *Paired sample t-test showed significant differences in the artemisinin-piperaquine (AP) group between before treatment and 3–8 days after treatment (P = 0.011 ).
See this image and copyright information in PMC

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