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An exploratory randomized controlled study on the efficacy and safety of lopinavir/ritonavir or arbidol treating adult patients hospitalized with mild/moderate COVID-19 (ELACOI)
Li Yueping.
Xie Zhiwei.
Lin Weiyin.
Cai Weiping.
Wen Chunyan.
Guan Yujuan.
Mo Xiaoneng.
Wang Jian.
Wang Yaping.
Peng Ping.
Chen Xudan.
Hong Wenxin.
Xiao Guangming.
Liu Jinxin.
Zhang Lieguang.
Hu Fengyu.
Li Feng.
Li Feng.
Zhang Fuchun.
Deng Xilong.
Li Linghua.
Acceso Abierto
Atribución-NoComercial-SinDerivadas
10.1101/2020.03.19.20038984
Background: Antiviral therapies against the novel coronavirus SARS-CoV-2, which has caused a global pandemic of respiratory illness called COVID-19, are still lacking. Methods: Our study (NCT04252885, named ELACOI), was an exploratory randomized (2:2:1) controlled trial assessing the efficacy and safety of lopinavir/ritonavir (LPV/r) or arbidol monotherapy for treating patients with mild/moderate COVID-19. Findings: This study successfully enrolled 86 patients with mild/moderate COVID-19 with 34 randomly assigned to receive LPV/r, 35 to arbidol and 17 with no antiviral medication as control. Baseline characteristics of the three groups were comparable. The primary endpoints, the average time of positive-to-negative conversion of SARS-CoV-2 nucleic acid and conversion rates at days 7 and 14, were similar between groups (all P>0.05). There were no differences between groups in the secondary endpoints, the rates of antipyresis, cough alleviation, or improvement of chest CT at days 7 or 14 (all P>0.05). At day 7, eight (23.5%) patients in the LPV/r group, 3 (8.6%) in the arbidol group and 2(11.8%) in the control group showed a deterioration in clinical status from moderate to severe/critical(P =0.206). Overall, 12 (35.3%) patients in the LPV/r group and 5 (14.3%) in the arbidol group experienced adverse events during the follow-up period. No apparent adverse event occurred in the control group. Conclusions: LPV/r or arbidol monotherapy present little benefit for improving the clinical outcome of patients hospitalized with mild/moderate COVID-19 over supportive care.
www.medrxiv.org
2020
Artículo
https://www.medrxiv.org/content/medrxiv/early/2020/03/23/2020.03.19.20038984.full.pdf
Inglés
VIRUS RESPIRATORIOS
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