v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | ISRCTN83971151 |
|
Full text link
Last imported at : May 12, 2022, 1:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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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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Contact
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
henaorestrepoa@who.int |
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Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2020-03-25 |
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Recruitment status
Last imported at : March 31, 2021, 4:03 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Not recruiting |
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Study design
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Open label |
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Center
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Treatment |
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Inclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
1. Adults (aged =18 years) hospitalized with definite COVID-19 2. Not already receiving any of the study drugs 3. Without known allergy or contraindications to any of them (in the view of the physician responsible for their care) 4. Without anticipated transfer within 72 h to a non-study hospital Patients invited to join the study will be those who are admitted to a collaborating hospital, no wider recruitment efforts are expected |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Current exclusion criteria as of 21/04/2020: 1. Any of the available study drugs are contra-indicated (e.g. because of patient characteristics, chronic liver or heart disease, or some concurrent medication) 2. Declined to participate in the study Previous exclusion criteria: 1. Any of the available study drugs are contra-indicated (e.g. because of patient characteristics, chronic liver or heart disease, or some concurrent medication) 2. Pregnant 3. Declined to participate in the study |
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Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
5 |
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Funding
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
World Health Organization |
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Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
None |
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Countries
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Argentina;Brazil;India;Canada;Germany;Honduras;Indonesia;Ireland;Iran;Israel;Italy;Kenya;Lebanon;Malaysia;Norway;Peru;Philippines;Qatar;Saudi Arabia;South Africa;Spain;Switzerland;Thailand |
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Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Moderate/severe/critical 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) |
5: Moderate/severe/critical 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) |
10000 |
|
primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
All-cause mortality; subdivided by the severity of disease at the time of randomization; measured using patient records throughout the study |
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Notes
Last imported at : July 30, 2021, 1:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
| Declared number of arm (5.0) differs from found arms (6.0) |
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Phase
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Phase 3 |
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Arms
Last imported at : July 30, 2021, 1:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1612, "treatment_name": "Interferon beta+lopinavir+ritonavir", "treatment_type": "Interferons+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |