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. 2020 Oct 14;11:562777. doi: 10.3389/fphar.2020.562777

Table 1.

Characteristics of CQ studies.

Study Study Type Country Treated Disorder (n patients) Trial Duration (weeks) Dosage Summary of Outcomes Intervention (n of patients) Age (mean or median) Total n of AEs Total n of serious AEs
*Arnaout et al. (2019) Double-Blinded, Placebo-Controlled, Randomized, Window of Opportunity Trial Canada Breast Cancer (70) 2–6 500 mg/day CQ or Placebo for 2–6 weeks No significant effects CQ: 46 57.4 ± 9.7 35 0
Control: 24 55.7 ± 8.4 8 0
Divala et al. (2018) Open-Label, Randomized, Single-Centered, Three-Armed United States/Malawi Placental Malaria (900) 20–28 of gestation to birth Days 1-2: 600 mg Day 3: 300 mg≥ 4 weeks later (CQ-IPTt) or 600 mg at enrollment, then 300 mg/week until delivery (prophylaxis) CQ IPTp was not better than SP-IPTp CQ: 600 33.00 ± 12.11 5 0
SP-IPTp: 300 33.95 ± 11.91 3 0
*Terrabuio et al. (2019) Double-Blinded, Interventional, Parallel-Group,
Placebo-Controlled, Randomized, Single-Centered
Brazil Autoimmune Hepatitis (AIH) (61) 156.4 250 mg/day for 36 months CQ safely reduced relapse risk of AIH; no subgroup with greater benefit from CQ use CQ: 31 37.7 ± 16.1 17 0
Control: 30 39.1 ± 16.9 5 0
Abreha et al. (2017) Randomized United States/Ethiopia Vivax Malaria (398) 6 25 mg/kg over 3 days Primaquine (PQ) + CQ or Artemether-Lumefantrine (AL) reduced vivax malaria recurrence 5 folds over 1 year CQ: 206 Median: 18 165 0
AL or AL+PQ: 192 CQ+PQ: 17
AL: 18
AL+PQ: 18
165 0
Grigg et al. (2018) Open-Label, Randomized, Two-Armed Australia/Malaysia Uncomplicated Plasmodium Knowlesi Malaria (123) 6 25 mg/kg at enrollment, 6, 24, and 48 h Artemether-Lumefantrine (AL) was effective at treating knowlesi malaria CQ: 58 Median: 31 25 0
AL: 65 Median: 30 29 0
Valecha et al. (2016) Multicentric, Open-Label, Phase III Study India Acute, Uncomplicated Plasmodium Vivax Malaria (317) ≥6 CQ: 4 doses (total 10 tablets of 250 mg each) for 3 days FDC of arterolane maleate (AM) and PQP cures vivax marlaria CQ: 158 33.7 ± 13.45 135 0
AM+PQP: 137 33.2 ± 11.81 127 4
Siqueira et al. (2017) Open-Label, Non-Inferiority, Randomized Brazil Vivax Malaria (380) 6 25 mg/kg over 3 days Artesunate-Amodiaquine (ASAQ) is more effective than CQ at preventing P. vivax infection CQ: 189 34.7 ± 15.9 52 0
ASAQ: 190 35.7 ± 16.4 68 5
Peymani et al. (2016) Triple-Blinded, Placebo-Controlled, Randomized, Pilot Iran Hepatitis C (10) 8 150 mg/day for 8 weeks CQ was potentially safe for HCV non-responders CQ: 6 49 0 7
Control: 13 50 0 0
Grigg et al. (2016) Open-Label, Randomized Australia/Malaysia Uncomplicated Plasmodium Knowlesi Malaria (252) 6 25 mg/kg at enrollment, 6, 24, and 48 h after treatment Artesunate-Mefloquine (AM) was highly effective at treating P. Knowlesi Malaria CQ: 125 Median: 32 316 0
AM: 127 Median: 33 302 2
Chopra et al. (2014) Assessor-Blinded, Parallel Efficacy, Randomized, Two-Armed India Musculoskeletal Pain and Arthritis Following Chikungunya virus infection (70) 24 250 mg/day for 24 weeks No significant improvement over meloxicam CQ: 38 50.2 7 0
Meloxicam: 32 45.4 5 0
*Borges et al. (2013) Double-Blinded, Placebo-Controlled, Randomized Brazil Dengue (129) 3 days 1,000 mg/day for 3 days CQ reduced pain; improved well-being of patients; but did not affect disease duration CQ: 63 31.64 ± 11.74 2 0
Control: 66 0 0
*Paton et al. (2011) Double-Blinded, Placebo-Controlled, Randomized Singapore Influenza (1,516) 12 Week 1: 500 mg/day Weeks 2–12: 500 mg/week No significant effects CQ: 757 23.6 341 3
Control: 759 23.5 249 5
Awab et al. (2010) Open-Label, Perspective, Randomized Afghanistan Vivax Malaria (536) 8 25 mg/kg for 3 days CQ was effective for Vivax Malaria treatment CQ: 268 Mean: 11 15 0
DP: 268 Median: 12 2 0
*Tricou et al. (2010) Double-Blinded, Placebo-Controlled, Randomized Vietnam Dengue (307) 3 days Days 1–2: 600 mg
Day 3: 300 mg
CQ did not reduce viraemia/NSI antigenaemia (AG) in dengue patients CQ: 153 22 18 0
Control: 154 22 6 0
*De Lamballerie et al. (2008) Double-Blinded, Placebo-Controlled, Randomized France Chikungunya Infection (54) 5 days Days 1–3: 600 mg/day Days 4-5: 300 mg/day No significant effect on acute Chikungunya infection CQ: 27 Range: 18-65 7 0
Control: 27 0 0
Villegas et al. (2007) Double-Blinded, Placebo-Controlled, Randomized Thailand Vivax Malaria in Pregnancy (1,000) Weekly till delivery 500 mg/week CQ was safe and effective as a prophylaxis against P. Vivax during pregnancy CQ: 500 26.1 ± 6.4 2 0
Control: 500 25.4 ± 6.3 1 0
Laufer et al. (2006) Randomized United States/Malawi Uncomplicated Plasmodium Falciparum Malaria (210) 4 Days 0–1: 10 mg/kg
Day 2: 5 mg/kg
CQ was effective in Malawi after 12 years CQ: 80 2.6 ± 2.2 0 0
Sulfadoxine-Pyrimethamine: 87 2.9 ± 2.2 0 0
Dunne et al. (2005) Double-Blinded, Randomized India Plasmodium Vivax Malaria (199) 4 Days 1–2: 600 mg
Day 3: 300 mg
CQ was tolerated as well, but was more effective CQ: 102 30.0 ± 11.8 33 2
Azithromycin: 97 31.7 ± 11.6 20 0
Mucenic et al. (2005) Pilot Study Brazil Remission of Autoimmune Hepatitis (32) ≥52 250 mg/day for ≥12 months CQ group had lower relapse frequency CQ: 14 27.29 ± 15.23 18 0
Control: 18 26 ± 13.59 0 0
Bezerra et al. (2005) Double-Blinded, Randomized Brazil Lupus Erythematosus (33) 26.1 250 mg/day for 6 months Clofazimine (CFZ) equally as effective as CQ diphosphate (CDP) CQ: 17 34.4 21 0
CFZ: 16 34 21 0
Llanos-Cuentas et al. (2001) Open-Label, Randomized, Comparison Peru Acute Plasmodium Falciparum Malaria (29) 4 Day 1: 600 mg
Days 2–3: 300 mg
Atovaquone/Proguanil (A/P) much more effective than CQ CQ: 14 Range: 12–65 29 0
A/P: 15 26 1
Hatz et al. (1998) Comparative, Open, Parallel Group, Randomized, Single-Centered Switzerland/Tanzania Acute Plasmodium Falciparum Malaria (26) 4 Day 1: 10 mg/kg
Days 2–4: 5 mg/kg
CGP-56697 highly effective against P. Falciparum in this part of Tanzania CQ: 130 Median: 2 17 0
CGP-56697: 130 Median: 2 6 0
Kofi Ekue et al. (1983) Double-Blinded, Randomized Zambia Symptomatic Falciparum Malaria (99) 6 Day 1: 900 mg
Days 2–3: 300 mg
No significant differences between MQ and CQ CQ: 49 Range: 13-51 62 0
MQ: 50 45 0