Table 2.
Characteristics of HCQ studies.
| Study | Study Type | Country | Treated Disorder (n patients) | Trial Duration (weeks) | Dosage | Summary of Outcomes | Intervention (n of patients) | Age | Total n of AEs | Total n of serious AEs |
|---|---|---|---|---|---|---|---|---|---|---|
| *Boulware et al. (2020) | Randomized, double-blind, placebo-controlled trial | United States and Canada | COVID-19 | 1 | 800 mg once, then 600 mg 6 to 8 h later, then 600 mg daily | HCQ did not prevent illness compatible with COVID-19 | HCQ: 349 | 41 | 140 | 0 |
| Control: 351 | 40 | 59 | 0 | |||||||
| *Jun et al. (2020) | Randomized Pilot Study | China | COVID-19 (30) | 1 | 400 mg/day for 5 days | Prognosis of common COVID-19 patients is good | HCQ: 15 | 50.5 ± 3.8 | 4 | 0 |
| Control: 15 | 46.7 ± 3.6 | 3 | 0 | |||||||
| *Cavalcanti et al. (2020) | Multicenter, randomized, open-label, controlled trial | Brazil | COVID-19 | 1 | 400 mg twice daily for 7 days | HCQ did not improve clinical status compared with standard care | HCQ: 221 | 51.3 ± 14.5 | 67 | 2 |
| Control: 227 | 49.9 ± 15.1 | 40 | 2 | |||||||
| *Mitjà et al. (2020) | Multicenter, open label, randomized controlled trial | Spain | COVID-19 | 1 | 800 mg on day 1, 400mg daily for 6 days | No benefit was observed with HCQ beyond the usual care | HCQ: 169 | 41.6 | 121 | 8 |
| Control: 184 | 41.7 | 16 | 12 | |||||||
| *Tang et al. (2020) | Multicenter, open label, randomized controlled trial | China | COVID-19 | 2-3 | 1,200 mg/d for 3 days and then 800 mg/d | HCQ did not result in a significantly higher probability of negative conversion of virus than control | HCQ: 70 | 48.0 | 21 | 2 |
| Control: 80 | 44.1 | 7 | 0 | |||||||
| *Boonpiyathad et al. (2017) | Single-Blind, Placebo-Controlled, Randomized | Thailand | Anti-Histamine Refractory Chronic Spontaneous Urticaria (CSU) (55) | 12 | 400 mg/day for 12 weeks | HCQ was effective as an adjunct treatment for CSU | HCQ: 46 | 33.00 ± 12.11 | 5 | 0 |
| Control: 24 | 33.95 ± 11.91 | 3 | 0 | |||||||
| *Wasko et al. (2015) | Double-Blinded, Parallel-Arm, Placebo-Controlled, Randomized | United States | Pre-Diabetes (32) | 13 ± 1 | 400 mg/day for 13 ± 1 weeks | HCQ improved both ß-cell function and insulin sensitivity in non-diabetic patients | HCQ: 17 | >18 | 3 | 0 |
| Control: 15 | 3 | 0 | ||||||||
| *Gottenberg et al. (2014) | Double-Blinded, Parallel-Group, Placebo-Controlled | France | Primary Sjogren’s Syndrome (120) | 48 | 400 mg/day Placebo or HCQ for 24 weeks, then 400 mg/day HCQ for 24 weeks | No significant effects | HCQ: 56 | 56.3 ± 11.9 | 5 | 5 |
| Control: 64 | 55.6 ± 13.9 | 7 | 7 | |||||||
| *Solomon et al. (2014) | Blinded, Crossover, Randomized | United States | Rheumatoid Arthritis and Insulin Resistance (30) | 16 | 6.5 mg/kg HCQ or placebo daily for 8 weeks, then crossover to other arm for 8 weeks | No significant change in insulin resistance; minor improvements to total LDL cholesterol | 15 (HCQ → Placebo) | 56 ± 11.4 | 2 | 0 |
| 15 (Placebo → HCQ) | 56 ± 11.4 | 0 | 0 | |||||||
| *Rotaru et al. (2014) | Randomized, Pilot, Triple Masking | United States | Kidney Failure, Chronic Cardiovascular Disease Arteriosclerosis (8) | 25 | 200 mg/day for 10 days ± 4 days, then 200 mg twice daily for 6 months | Terminated (Lack of Funding) | HCQ: 7 | 18-65: 4 >65: 3 |
2 | 0 |
| Control: 1 | 18–65: 1 | 0 | 0 | |||||||
| *Paton et al. (2012) | Double-Blinded, Randomized, Placebo-Controlled | United Kingdom | HIV (83) | 48 | 400 mg/day for 48 weeks | No significant effects | HCQ: 42 | 37.1 ± 7.7 | 41 | 0 |
| Control: 41 | 38.3 ± 10.8 | 26 | 0 | |||||||
| *Fong et al. (2007) | Double-Blinded, Placebo-Controlled, Randomized | United States | Chronic Graft-Versus-Host Disease (95) | 55 | 121 days at 800 mg/day | No effects | HCQ: 46 | 48 | 1 | 0 |
| Control: 49 | 46 | 1 | 0 | |||||||
| *Gerstein et al. (2002) | Double-Blinded, Placebo-Controlled, Randomized | Canada | Type 2 Diabetes Mellitus (135) | 78.2 | 300 mg first month, 450 mg s, and 600 mg third, daily | HCQ improved glycemic control in patients with poorly controlled type 2 diabetes | HCQ: 69 | 57.5 | 3 | 0 |
| Control: 66 | 57.5 | 1 | 0 | |||||||
| *Van Gool et al. (2001) | Double-Blinded, Parallel-Group, Multicenter | The Netherlands | Dementia in Early Alzheimer’s Disease (168) | 78.2 | <65 kg: 200 mg/day >65 kg: 400 mg/day; 18 months |
No significant effects | HCQ: 83 | 70.4 ± 8.3 | 20 | 5 |
| Control: 85 | 70.7 ± 8.5 | 15 | 2 | |||||||
| *Sperber et al. (1995) | Double-Blinded, Placebo-Controlled, Randomized | United States | HIV-1 (40) | 8 | 800 mg/day for 8 weeks | HIV-1 RNA declined significantly in the HCQ group over 8 weeks; increased in placebo group | HCQ: 19 | 39.1 ± 6.6 | 0 | 0 |
| Control: 19 | 40.6 ± 12.5 | 0 | 0 | |||||||
| *The HERA Study Group (1995) | Double-Blinded, Placebo-Controlled, Randomized | Canada | Early Rheumatoid Arthritis (120) | 36 | 200 mg/day for 2 weeks. If no side effects, 400 mg/day | Improved pain and disability of recent arthritis | HCQ: 59 | 53 ± 13.5 | 25 | 1 |
| Control: 60 | 53 ± 14.8 | 19 | 0 | |||||||
| *Clark et al. (1993) | Double-Blinded, Placebo-Controlled, Randomized | Mexico | Early Rheumatoid Arthritis (126) | 24 | 400 mg/day for 24 weeks | HCQ effectively improved early rheumatoid arthritis | HCQ: 65 | 39 | 28 | 0 |
| Control: 65 | 36 | 28 | 1 | |||||||
| *Kruize et al. (1993) | Double-Blinded, Crossover, Placebo-Controlled | The Netherlands | Primary Sjogren’s Syndrome (19) | 52.2 | 400 mg/day for 12 months | No significant effects | 10 (HCQ → Placebo) | 52.8 ± 16.1 | 0 | 1 |
| 9 (Placebo → HCQ) | 51 ± 15.8 | 0 | 0 | |||||||
| Faarvang et al. (1993) | Double-Blinded, Multicenter, Parallel-Group, Placebo-Controlled, Randomized | Denmark | Rheumatoid Arthritis (91) | 26.1 | 250 mg/day HCQ and 2g/day Placebo OR 250 mg/day + S for 6 months | HCQ and Sulphasalazine (S) had no improvement over HCQ alone | 62 (HCQ + Placebo & HCQ + Sulphasalazine) | 61 | 7 | 0 |
| 29 (Placebo + Sulphasalazine) | 61 | 0 | 0 |