A trial of arbidol hydrochloride in adults with COVID-19
10.1097/CM9.0000000000002104
- VernacularTitle:A trial of arbidol hydrochloride in adults with COVID-19
- Author:
Jingya ZHAO
1
;
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
Author Information
1. Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China
- Keywords:
Arbidol;
Coronavirus disease 2019 (COVID-19);
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- From:
Chinese Medical Journal
2022;135(13):1531-1538
- CountryChina
- Language:Chinese
-
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 < 0.001), as well as hospitalization (median 12.5 days vs. 20.0 days; P < 0.001). Moreover, the addition of arbidol tablets to SOC led to more rapid normalization of declined blood lymphocytes (median 10.0 days vs. 14.5 days; 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
