Table 2.
Summary of the non-peer-reviewed (at the time of preparing this manuscript) clinical studies from pre-print servers on the therapeutic role of HCQ in COVID-19
| Author (country) | Study design | Sample size (treatment/control) and male (%) | Age in years (mean ± SD or range) | Inclusion criteria | Study arms | Primary outcome | Results of the primary outcomes | Key adverse events with HCQ use |
|---|---|---|---|---|---|---|---|---|
| Chen et al. [26] (China) | Randomized controlled trial | 62 (31/31) (46.8% male) | 44.7 ± 15.3 | Tested positive for COVID-19 |
Treatment: 200 mg of HCQ twice daily for 5 days plus standard treatment Control: standard treatment |
Time to clinical recovery | The time to clinical recovery was significantly shortened with HCQ treatment | Rash and headache |
| Mahévas et al. [27] (France) | Hospital record-based observational study | 181 (84/97) (71.1% male) | 18–80 | Tested positive for COVID-19 | HCQ group: 600 mg of HCQ within 48 h of hospitalization Non-HCQ group: no HCQ | Transfer to the ICU within 7 days of inclusion and/or death from any cause | 20.2% of patients in the HCQ group were transferred to the ICU or died within 7 days vs. 22.1% in the non-HCQ group | QT prolongation, first-degree atrioventricular block, right bundle branch block, ICU transfer |
| Magagnoli et al. [28] (USA) | Retrospective analysis of hospital records (observational study) | 368 (100% male) | > 65 years | Patients hospitalized with COVID-19 | HCQ alone or in combination with azithromycin | Death and the need for mechanical ventilation | Increased overall mortality with HCQ monotherapy, and HCQ alone or in combination with azithromycin did not reduce the risk of mechanical ventilation | Increased mortality following HCQ monotherapy |
| Tang et al. [29] (China) | Randomized controlled trial | 150 (75/75) (55% male) | 46.1 ± 14.7 | Tested positive for COVID-19 |
HCQ group: 1200 mg daily for three days followed by 800 mg daily for 2 (mild/moderate patients) or 3 (severe patients) weeks plus standard treatment Control: plus standard treatment |
28-day negative conversion rate of SARS-CoV-2 | The overall 28-day negative conversion rate was similar between the two groups | Upper respiratory tract infection, diarrhea, and blurred vision |
| Ramireddy et al. [30] (USA) | Retrospective analysis of hospital records (observational study) | 98 (61% male) | 62 ± 17 | Tested positive for COVID-19, treated with HCQ alone or in combination with azithromycin, and with two electrocardiograms performed | HCQ alone or in combination with azithromycin | Baseline QTc and post-medication critical QTc prolongation | With the drug combination, the QTc prolongation was several-fold | QT prolongation |
All studies involved hospitalized (non-ICU) patients with conformed SARS-CoV-2 infection
COVID-19 Coronavirus Disease-19, HCQ hydroxychloroquine, ICU intensive care unit