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. 2021 Feb 15;11(1):93–107.

Table 1.

Summary of RCTs evaluating use of CQ and HCQ for treatment of COVID-19 patients

Study, Publication status Trial Registry Identifier Country Design No. of Participants Participants Study (trial) arms Outcomes
Abd-Elsalam et al., 2020; Published NCT04353336 Egypt RCT, Open label 194 Severity: Mild, moderate, and severe Arm 1: HCQ Primary
Age, Mean ± SD: 40.7 ± 19.3 yrs Arm 2: Usual care (Control group)     1). Clinical recovery
Sex, Female: 41.2%     2). Need for mechanical ventilation
    3). Mortality within 28 days
Secondary
    Adverse/Side effects
Cavalcanti et al., 2020; Published NCT04322123 Brazil RCT, Open label 667 Severity: Mild to moderate Arm 1: HCQ and Azithromycin Primary
Age, Mean ± SD: 50.3 ± 14.6 yrs Arm 2: HCQ alone     Clinical status on Day 15
Sex, Female: 41.7% Arm 3: Usual care (Control) Secondary
    1). Clinical status at 7 days
    2). An indication for intubation within 15 days
    3). Receipt of supplemental oxygen between randomization and 15 days
    4). Duration of hospital stay
    5). In-hospital death
C. Chen et al., 2020; Preprint NCT04384380 Taiwan RCT, Open label 33 Severity: Mild to moderate Arm 1: HCQ Primary
Age, Mean ± SD: 32.9 ± 10.7 yrs Arm 2: Usual care (Control)     Time to negative rRT-PCR assessments from randomization up to 14 days
Sex, Female: 42.4% Secondary
    1). Proportion of negative viral PCR on Day 14
    2). Time to clinical recovery
    3). Proportion of discharges by Day 14
    4). Mortality rate
    5). Safety and tolerability
J. Chen et al., 2020; Published NCT04261517 China RCT, Open label 30 Severity: Moderate Arm 1: HCQ Primary
Age, Mean ± SD: 48.6 ± 3.6 yrs Arm 2: Usual care (Control)     Proportion of patients with negative rRT-PCR in pharyngeal swab on Day 7
Sex, Female: 30% Secondary
    1). Occurrence of severe drug toxicity
L. Chen et al., 2020; Preprint ChiCTR2000030054 China RCT, Open label 48 Severity: Moderate to severe hospitalized Arm 1: CQ Phosphate Primary
Age, Mean ± SD: 46.9 ± 14.6 yrs Arm 2: HCQ     Time to clinical recovery
Sex, Female: 54.2% Arm 3: Usual care Secondary
    1). Time to negative rRT-PCR assessments
    2). Length of hospital stay
    3). Duration (days) of supplemental oxygenation
    4). Adverse events
    5). All-cause mortality
Z. Chen et al., 2020; Preprint ChiCTR2000029559 China RCT, double blind 62 Severity: Mild hospitalized Arm 1: HCQ Sulphate Primary
Age, Mean ± SD: 44.7 ± 15.3 yrs Arm 2: Usual care (Control)     Time to clinical recovery
Sex, Female: 53.2% Secondary
    Adverse effects
Horby et al., 2020; Preprint NCT04381936 UK RCT, Open label 4,716 Severity: Mild, moderate, and severe hospitalized Arm 1: HCQ Primary
Age, Mean ± SD: 65.3 ± 15.3 yrs Arm 2: Usual care (Control)     All-cause mortality by Day 28
Sex, Female: 38.8% Secondary
    1). Time to discharge from hospital and
    2). Invasive mechanical ventilation
    3). Cause-specific mortality
    4). Major cardiac arrhythmia (recorded in a subset),
    5). Receipt and duration of ventilation.
Kamran et al., 2020; Preprint NCT04491994 Pakistan RCT, Open label 500 Severity: Mild Arm 1: HCQ Primary
Age, Mean ± SD: 35.9 ± 11.2 yrs Arm 2: Usual care (Control)     Clinical progression of disease as per WHO criteria
Sex, Female: 6.8% Secondary
    PCR negativity on Day 7 and Day 14
Mitja et al., 2020; Published NCT04304053 Spain RCT, Open label 293 Severity: Mild non-hospitalized Arm 1: HCQ Primary
Age, Mean ± SD: 41.7 ± 12.5 yrs Arm 2: Usual care (Control)     Reduction of viral RNA load in nasopharyngeal swabs at day 3 and day 7 after treatment start
Sex, Female: 68.6% Secondary
    1). Clinical progression up to 28 days
    2). TTCR of symptoms within 28 days
    3). Adverse events up to Day 28
Skipper et al., 2020; Published NCT04308668 US, Canada RCT, double blind 491 Severity: Mild to moderate non-hospitalized Arm 1: HCQ Primary
Age, Median (IQR): 40.0 (32 to 50) yrs Arm 2: Placebo (Control)     1). Presence and severity of COVID-19 symptoms
Sex, Female: 56%     2). Hospitalization status
Secondary
    1). Medication adherence
    2). Adverse effects
Tang et al., 2020; Published ChiCTR2000029868 China RCT, Open label 150 Severity: Mild to moderate hospitalized Arm 1: HCQ Primary
Age, Mean ± SD: 46.1 ± 14.7 yrs Arm 2: Usual care (Control)     1). Negative conversion of SARS-CoV-2 by Day 28
Sex, Female: 45%     2). Clinical improvement in severity symptoms by Day 28
Secondary
    1). Alleviation of clinical symptoms
    2). All-cause mortality
    3). Disease progression in patients