Objective: To evaluate the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of patients with moderate coronavirus disease 2019 (COVID-19).
Methods: We prospectively enrolled 30 treatment-naïve patients with confirmed COVID-19 after informed consent at Shanghai Public Health Clinical Center. The patients were randomized 1：1 to HCQ group and the control group. Patients in HCQ group were given HCQ 400 mg per day for 5 days plus conventional treatments, while those in the control group were given conventional treatment only. The primary endpoint was negative conversion rate of SARS-CoV-2 nucleic acid in respiratory pharyngeal swab on days 7 after randomization. This study has been approved by the Ethics Committee of Shanghai Public Health Clinical Center and registered online (NCT04261517).
Results: One patient in HCQ group developed to severe during the treatment. On day 7, nucleic acid of throat swabs was negative in 13 (86.7%) cases in the HCQ group and 14 (93.3%) cases in the control group (P>0.05). The median duration from hospitalization to virus nucleic acid negative conservation was 4 (1,9) days in HCQ group, which is comparable to that in the control group [2 (1,4) days, Z=1.27, P>0.05]. The median time for body temperature normalization in HCQ group was 1 (0,2) day after hospitalization, which was also comparable to that in the control group [1 (0,3) day]. Radiological progression was shown on CT images in 5 cases (33.3%) of the HCQ group and 7 cases (46.7%) of the control group, and all patients showed improvement in follow-up examinations. Four cases (26.7%) of the HCQ group and 3 cases (20%) of the control group had transient diarrhea and abnormal liver function (P>0.05).
Conclusions: The prognosis of COVID-19 moderate patients is good. Larger sample size study are needed to investigate the effects of HCQ in the treatment of COVID-19. Subsequent research should determine better endpoint and fully consider the feasibility of experiments such as sample size.
目的: 初步评价硫酸羟氯喹治疗2019冠状病毒病（COVID-19）普通型患者的疗效和安全性。
方法: 收集2020年2月6至25日在上海市公共卫生临床中心住院治疗的30例COVID-19普通型患者。患者1：1随机分配到试验组和对照组。对照组接受常规治疗，试验组在常规治疗的基础上口服硫酸羟氯喹（400 mg，1次/d）治疗，疗程为5 d。比较两组治疗第7天时咽拭子病毒核酸转阴率等指标。研究获上海市公共卫生临床中心伦理委员会批准，并登记注册（NCT04261517）。
结果: 在治疗过程中，试验组1例患者发展为重型。入组后第7天，试验组中13例（86.7%）和对照组中14例（93.3%）患者咽拭子病毒核酸检测为阴性（ P>0.05）。在2周的访视期内，所有受试者的咽拭子核酸检测均转为阴性，其中试验组咽拭子核酸转阴时间为入院后第4（1，9）天，对照组为第2（1，4）天，差异无统计学意义（ Z=1.27， P>0.05）。试验组在入院后第1（0，2）天体温恢复正常，对照组在入院后第1（0，3）天体温恢复正常。影像学检查结果显示，试验组5例（33.3%）和对照组7例（46.7%）患者均在入院3 d后的复查中出现了进展，所有患者在随后的复查中均提示病灶好转。试验组和对照组分别有4例（26.7%）和3例（20.0%）患者出现一过性的腹泻和肝功能异常等不良反应，两组不良反应发生率差异无统计学意义（ P>0.05）。
结论: 目前COVID-19普通型患者预后较好，以病毒转阴率、重症化率为主要终点的研究难以对药物的疗效进行判断。开展后续的研究需要确定更合适的人群和终点事件，并充分考虑样本量等试验的可行性问题。