[A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19].
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 32391667 · doi:10.3785/j.issn.1008-9292.2020.03.03
What was done
This prospective randomized pilot trial enrolled 30 treatment-naïve patients hospitalized with moderate COVID-19 at Shanghai Public Health Clinical Center. Patients were randomized 1:1 to receive oral hydroxychloroquine (400 mg daily for 5 days) plus conventional care (n = 15) or conventional care alone (n = 15). The primary endpoint was the SARS-CoV-2 nucleic acid negative conversion rate on pharyngeal swabs at day 7 after randomization. Secondary endpoints included time to viral clearance, time to fever normalization, CT radiological changes, and adverse events.
What was found
On day 7, throat swab viral negativity was achieved in 13 of 15 (86.7%) patients in the hydroxychloroquine group and 14 of 15 (93.3%) in the control group (P > 0.05). Median time to viral negative conversion was 4 days (range 1–9) with hydroxychloroquine versus 2 days (range 1–4) with control (Z = 1.27, P > 0.05). Median time to body temperature normalization was 1 day (0–2) in the hydroxychloroquine group and 1 day (0–3) in the control group. One patient in the hydroxychloroquine group progressed to severe disease. CT radiological progression occurred in 5 of 15 (33.3%) hydroxychloroquine patients and 7 of 15 (46.7%) control patients. Adverse effects (transient diarrhea and abnormal liver function) occurred in 4 of 15 (26.7%) versus 3 of 15 (20.0%) patients (P > 0.05).
Why it matters
This early pilot randomized trial provided initial clinical evidence that short-course hydroxychloroquine did not accelerate viral clearance or improve clinical recovery in hospitalized moderate COVID-19 patients.
Limits
The sample size was very small (30 patients total), creating severe imprecision and leaving the trial underpowered. It was conducted at a single center, blinding was not reported in the abstract, and conventional background treatments were not specified.
Cited by
- supports A pilot study from China found patients with mild to moderate COVID-19 had no significant difference in recovery rates when given hydroxychloroquine compared to controls.