Table 1.
Human hydroxychloroquine (HCQ) COVID-19 studies published as of April 6, 2020 [[3], [4], [5], [6], [7], [8]]
| Study author, yr, study design, location (reference #) | Sample size; mean/median age; % male | Intervention; comparator | Reported outcomes | Critical appraisal |
|---|---|---|---|---|
| RCTs | ||||
| Chen, 2020, RCT, China [3] | 30; 15 HCQ, 15 control; 48.5 mean; 70% | HCQ 400 mg per day for 5 days plus SoC, control received SoC | Negative conversion rate | Small sample size, small events, unclear reporting of methods, unclear/absent randomization, concealment, blinding, suboptimal outcomes, sparse reporting on methods |
| Chen, 2020, RCT, China [4] | 62; 31 HCQ; 31 control; mean 44.7 (SD 15.3); 46.8% | 5-day HCQ (400 mg/d), control received SoC | Time to clinical recovery (TTCR), clinical characteristics, and radiological results, adverse events | RCT, small sample size, small number of events, unclear reporting of methods, suboptimal methods, suboptimal outcomes, sparse reporting on methods |
| Huang, 2020, RCT, China [5] | 22; 44.0 mean (36.5 to 57.5); 59.1% | twice-daily oral of 500 mg Chloroquine (n = 10) vs. 400/100 mg Lopinavir/Ritonavir (n = 12) for 10 days | Disease progression by RT-PCR, lung pathology with CT, fever, respiratory rate, oxygen saturation and adverse events | RCT, small sample size, small events, unclear reporting of methods, unclear/absent randomization, concealment, blinding, suboptimal outcomes, sparse reporting on methods |
| Observational studies | ||||
| Gautret, 2020, open-label nonrandomized observational study, France [6] | 42; 26 HCQ, 16 control; 45.1 ± 22.0 (mean/SD); 41.7% | HCQ 600 mg daily 6 d n = 26 (AZ added depending on clinical presentation), control n = 16 (6 lost in f/up due to cessation of treatment, 1 died, 3 to ICU) | Virologic cure, length of hospital stay, mortality, adverse events | Observational, small sample, > 20% attrition in intervention arm, control group taken from different care center, unclear accounting of patients lost/removed from analysis, heterogenous allocation of cotreatments, decisions based on clinician judgment, unadjusted analysis, sparse reporting on methods; considered hypothesis generating |
| Gautret, 2020, case-series observational, France [7] | 80; 52.5 median, 52.5% | 200 mg of HCQ three times per day for 10 days combined with AZ (500 mg on D1 followed by 250 mg per day for the next 4 days) | Need for oxygen therapy; transfer to the ICU after at least 3 days of treatment, contagiousness (PCR and culture) and length of stay ID ward | Observational study, no control arm; small sample size, small number of events, unadjusted analysis, no matching, stratification, restriction, sparse reporting on methods; considered hypothesis generating |
| Molina, 2020, consecutive case-series observational, France [8] | 11; 58.7 mean, 64% | HCQ 600 mg/d for 10 days and AZ 500 mg Day 1 and 250 mg days 2 to 5 | Virologic cure (positive tests) | Observational study, no control arm; small sample size, small number of events, unadjusted analysis; considered hypothesis generating |
Abbreviations: AZ, azithromycin; CT, computed tomography scan; HCQ, hydroxychloroquine; ICU, intensive care unit; ID, infectious disease; RCT, randomized controlled trial; RT-PCR, reverse transcription polymerase chain reaction.