[A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19]

Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 May 25;49(2):215-219. doi: 10.3785/j.issn.1008-9292.2020.03.03.
[Article in Chinese]

Abstract

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Betacoronavirus* / isolation & purification
  • China
  • Coronavirus Infections / diagnostic imaging
  • Coronavirus Infections / drug therapy
  • Humans
  • Hydroxychloroquine* / therapeutic use
  • Pandemics
  • Pilot Projects
  • Pneumonia, Viral / diagnostic imaging
  • Pneumonia, Viral / drug therapy
  • RNA, Viral / isolation & purification
  • Treatment Outcome

Substances

  • RNA, Viral
  • Hydroxychloroquine

Supplementary concepts

  • COVID-19
  • severe acute respiratory syndrome coronavirus 2

Associated data

  • ClinicalTrials.gov/NCT04261517