Dr. Ozonoff (BU) writes to me about the "[o]nly controlled trial so far of hydroxychloroquine [the anti-malaria drug]," which appears in a paper from Journal of the Zhejiang University...in Chinese...but the Abstract is in English. This is a very small trial (15 subjects per arm) so hard to draw firm conclusions, but there is zero effect of hydroxychloroquine with these endpoints (disappearance of viral nucleic acids in throat swab after a week; time until negative swab; time to become afebrile; 'radiologic progression' in CT [not sure what this means]; clinical improvement)." Here's the abstract:
[Abstract] Objective: To evaluate the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of patients with common coronavirus disease-19 (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 COVID-19 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, COVID-19 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, (U = 83.5, P ＞ 0.05)]. The median time for body temperature normalization in HCQ group was 1 (0-2) after hospitalization, which was also comparable to that in the control group 1 (0-3). 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 examination. 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 common COVID-19 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.
Dr. Ozonoff comments: "Certainly not conclusive but not exactly encouraging, either." (Some of the problems with the earlier French study, that got so much attention, are discussed here [thanks to Nathan Ballantyne for the pointer].)
