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)

Abstract 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 (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04252885">NCT04252885</jats:ext-link>, 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&gt;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&gt;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.Funding This study was supported by project 2018ZX10302103-002, 2017ZX10202102-003-004 and Infectious Disease Specialty of Guangzhou High-level Clinical Key Specialty (2019-2021)..

Medienart:	Preprint

Erscheinungsjahr:	2020
Erschienen:	2020

Enthalten in:	bioRxiv.org - (2020) vom: 21. Nov. Zur Gesamtaufnahme - year:2020

Sprache:	Englisch

Beteiligte Personen:

Li, Yueping [VerfasserIn] Xie, Zhiwei [VerfasserIn] Lin, Weiyin [VerfasserIn] Cai, Weiping [VerfasserIn] Wen, Chunyan [VerfasserIn] Guan, Yujuan [VerfasserIn] Mo, Xiaoneng [VerfasserIn] Wang, Jian [VerfasserIn] Wang, Yaping [VerfasserIn] Peng, Ping [VerfasserIn] Chen, Xudan [VerfasserIn] Hong, Wenxin [VerfasserIn] Xiao, Guangming [VerfasserIn] Liu, Jinxin [VerfasserIn] Zhang, Lieguang [VerfasserIn] Hu, Fengyu [VerfasserIn] Li, Feng [VerfasserIn] Zhang, Fuchun [VerfasserIn] Deng, Xilong [VerfasserIn] Li, Linghua [VerfasserIn]

Links:	Volltext [kostenfrei]

doi:	10.1101/2020.03.19.20038984

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	XBI000812536