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)
| Autor: | 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, Zhang, Fuchun, Deng, Xilong, Li, Linghua |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Coronavirus disease 2019 (COVID-19) Adult patients business.industry Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Lopinavir/ritonavir Lopinavir law.invention Randomized controlled trial law Internal medicine Medicine Ritonavir business Adverse effect medicine.drug |
| Popis: | BackgroundAntiviral therapies against the novel coronavirus SARS-CoV-2, which has caused a global pandemic of respiratory illness called COVID-19, are still lacking.MethodsOur 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.FindingsThis 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.ConclusionsLPV/r or arbidol monotherapy present little benefit for improving the clinical outcome of patients hospitalized with mild/moderate COVID-19 over supportive care.FundingThis study was supported by project 2018ZX10302103-002, 2017ZX10202102-003-004 and Infectious Disease Specialty of Guangzhou High-level Clinical Key Specialty (2019-2021). |
| Databáze: | OpenAIRE |
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