Trial registration number
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ChiCTR2000029740 |
Full text link
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.chictr.org.cn/showproj.aspx?proj=49317
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First author
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Zhuoli Zhang
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Contact
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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zhuoli.zhang@126.com
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Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-02-11
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Recruitment status
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Patients with novel coronavirus infection who agreed to participate in this trial and signed the informed consent form. The diagnose criteria was according to Diagnostic and treatment protocol of COVID-19 pneumonia published by Chinese General Office of National Health Committee(6th and further edition).
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Exclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Patients who is enrolled in other clinical trial
who had diagnosed as macular degeneration of retinawere or defects of visual field,
who was allergic to 4-aminoquinoline compounds or is prescribed any drug had interactions with hydrocholoroquine
emergency or critically ill patients who can not received oral drugs
pregnancy or lactation
severe heart disease, digestive disease,neurological or ocular disease,or porphyrin,
WBC less than 2.0*10^9/L,hemoglobin 60g/L,liver enzyme or creatine higher than 3 times of ULT,or heart marker elevated,
unsuitable to participate this trial by investigator or in other special circumstances.
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Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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The First Hospital of Peking University
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Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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16
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Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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99
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Countries
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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China
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Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Mild/moderate disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2: Mild/moderate disease at enrollment
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Total sample size
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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78
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primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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oxygen index;max respiratory rate;lung radiography;count of lymphocyte;temperature;other infection;time when the nuleic acid of the novel coronavirus turns negative;prognosis;
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Notes
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 4
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Arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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