Real-world experience of arbidol for Omicron variant of SARS-CoV-2

Jingya Zhao; Yong Li; Rong Chen; Yanping Xu; Qingyuan Yang; Haiqing Zhang; Zhengxin Yin; Weiting Gu; Jinsong Hu; Li Chen; Jian Li; Guang Ning; Qijian Cheng; Min Zhou; Jieming Qu

doi:10.21037/jtd-22-980

Real-world experience of arbidol for Omicron variant of SARS-CoV-2

J Thorac Dis. 2023 Feb 28;15(2):452-461. doi: 10.21037/jtd-22-980. Epub 2023 Feb 5.

Authors

Jingya Zhao^#^{1

2

3}, Yong Li^#^{1

2

3}, Rong Chen^#^{1

2

3}, Yanping Xu^{1

2

3}, Qingyuan Yang^{1

2

3}, Haiqing Zhang^{1

2

3}, Zhengxin Yin⁴, Weiting Gu⁵, Jinsong Hu⁶, Li Chen⁷, Jian Li⁸, Guang Ning⁹, Qijian Cheng^{1

2

3}, Min Zhou^{1

2

3}, Jieming Qu^{1

2

3}

Affiliations

¹ Department of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
² Institute of Respiratory Disease, Shanghai Jiaotong University School of Medicine, Shanghai, China.
³ Shanghai Key Laboratory of Emergency Prevention, Diagnosis and Treatment of Respiratory Infectious Disease, Shanghai, China.
⁴ Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
⁵ Department of Neurosurgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
⁶ Department of Traumatology of Traditional Chinese Medicine, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
⁷ Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
⁸ Clinical Research Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
⁹ Shanghai National Research Centre for Endocrine and Metabolic Disease, State Key Laboratory of Medicine Genomics, Shanghai Institute for Endocrine and Metabolic Disease, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

^# Contributed equally.

Abstract

Background: At a crucial time with the rapid spread of Omicron severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus variant globally, we conducted a study to evaluate the efficacy and safety of arbidol tablets in the treatment of this variant.

Methods: From Mar 26 to April 26, 2022, we conducted a prospective, open-labeled, controlled, and investigator-initiated trial involving adult patients with confirmed Omicron variant infection. Patients with asymptomatic or mild clinical status were stratified 1:2 to receive either standard-of-care (SOC) or SOC plus arbidol tablets (oral administration of 200 mg per time, three times a day for 5 days). The primary endpoint was the negative conversion rate within the first week.

Results: A total of 367 patients were enrolled in the study; 246 received arbidol tablet treatment, and 121 were in the control 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 [47.2% (116/246) vs. 35.5% (43/121); odds ratio (OR), 1.619; 95% confidence interval (CI): 1.034-2.535; P=0.035]. Compared to those in the SOC group, patients receiving arbidol tablets had a shorter negative conversion time [median 8.3 vs. 10.0 days; hazard ratio (HR), 0.645; 95% CI: 0.516-0.808; P<0.001], and a shorter duration of hospitalization (median 11.4 vs. 13.7 days; HR, 1.214; 95% CI: 0.966-1.526; P<0.001). Moreover, the addition of arbidol tablets led to better recovery of declined blood lymphocytes, CD3⁺, CD4⁺, and CD8⁺ cell counts. The most common adverse event (AE) was transaminase elevation in patients treated with arbidol tablets (3/246, 1.2%). No one withdrew from the study due to AEs or disease progression.

Conclusions: As a whole, arbidol may represent an effective and safe treatment in asymptomatic-mild patients suffering from Omicron variant during the pandemic of coronavirus disease 2019 (COVID-19).

Keywords: Arbidol; Omicron; efficacy; safety; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).