A trial of arbidol hydrochloride in adults with COVID-19

Autor: Jingya Zhao, Jinnong Zhang, Yang Jin, Zhouping Tang, Ke Hu, Hui Sun, Mengmeng Shi, Qingyuan Yang, Peiyu Gu, Hongrong Guo, Qi Li, Haiying Zhang, Chenghong Li, Ming Yang, Nian Xiong, Xuan Dong, Juanjuan Xu, Fan Lin, Tao Wang, Chao Yang, Bo Huang, Jingyi Zhang, Shi Chen, Qiong He, Min Zhou, Jieming Qu, Peifang Wei
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Chinese Medical Journal, Vol 135, Iss 13, Pp 1531-1538 (2022)
Druh dokumentu: article
ISSN: 0366-6999
2542-5641
00000000
DOI: 10.1097/CM9.0000000000002104
Popis: Abstract. Background:. To date, there is no effective medicine to treat coronavirus disease 2019 (COVID-19), and the antiviral efficacy of arbidol in the treatment for COVID-19 remained equivocal and controversial. The purpose of this study was to evaluate the efficacy and safety of arbidol tablets in the treatment of COVID-19. Methods:. This was a prospective, open-label, controlled and multicenter investigator-initiated trial involving adult patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Patients were stratified 1:2 to either standard-of-care (SOC) or SOC plus arbidol tablets (oral administration of 200 mg per time, three times a day for 14 days). The primary endpoint was negative conversion of SARS-CoV-2 within the first week. The rates and 95% confidential intervals were calculated for each variable. Results:. A total of 99 patients with laboratory-confirmed SARS-CoV-2 infection were enrolled; 66 were assigned to the SOC plus arbidol tablets group, and 33 to the SOC group. The negative conversion rate of SARS-CoV-2 within the first week in patients receiving arbidol tablets was significantly higher than that of the SOC group (70.3% [45/64] vs. 42.4% [14/33]; difference of conversion rate 27.9%; 95% confidence interval [CI], 7.7%–48.1%; P = 0.008). Compared to those in the SOC group, patients receiving arbidol tablets had a shorter duration of clinical recovery (median 7.0 days vs. 12.0 days; hazard ratio [HR]: 1.877, 95% CI: 1.151–3.060, P = 0.006), symptom of fever (median 3.0 days vs. 12.0 days; HR: 18.990, 95% CI: 5.350–67.410, P 0.05). The most common adverse event in the arbidol tablets group was the elevation of transaminase (5/200, 2.5%), and no one withdrew from the study due to adverse events or disease progression. Conclusions:. SOC plus arbidol tablets significantly increase the negative conversion rate of SARS-CoV-2 within the first week and accelerate the recovery of COVID-19 patients. During the treatment with arbidol tablets, we find no significant serious adverse events. Trial registration:. Chinese Clinical Trial Registry, NCT04260594, www.clinicaltrials.gov/ct2/show/NCT04260594?term=NCT04260594&draw=2&rank=1
Databáze: Directory of Open Access Journals
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