| Trial registration number
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NCT04323527 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04323527
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First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Marcus Lacerda
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Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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marcuslacerda.br@gmail.com
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-03-26
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Recruitment status
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
male and female participants aged over 18 years old
hospitalized
presenting:
respiratory rate higher than 24 breathing incursions per minute and/or
heart rate higher than 125 beats per minute (in the absence of fever) and/or
peripheral oxygen saturation lower than 90% in ambient air and/or
shock (defined as mean arterial pressure less than 65 mmhg, requiring vasopressor or oliguria or lowering level of consciousness)
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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• none.
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Number of arms
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Brazil
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Severe disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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6: Severe disease at enrollment
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Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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278
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Mortality rate reduction of 50% by day 28
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
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Phase 2
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Arms
Last imported at : June 23, 2021, 1:30 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}]
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