| Trial registration number
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NCT04954040 |
Full text link
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04954040
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First author
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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Antonio Miguel Luque Pineda
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Contact
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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uicec@imibic.org
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Registration date
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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2021-07-08
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Recruitment status
Last imported at : April 6, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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Open 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 : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- patients with positive semi-quantitative pcr and covid19 symptoms (fever, cough,
diarrhea, dyspnoea, loss of smell).
- signed informed consent
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Exclusion criteria
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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- retinal degeneration.
- congenital or acquired long qt syndrome.
- advanced liver failure.
- renal insufficiency (incompatible with creatinine clearance less than 50 ml /minute).
- allergic to hydroxychloroquine or azithromycin.
- serious interaction with the drugs used.
- pregnant or breastfeeding.
- men and women in fertile and sexually active periods, who do not accept a highly
effective contraceptive method.
- inability to follow study procedures.
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Number of arms
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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Maimónides Biomedical Research Institute of Córdoba
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Inclusion age min
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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90
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Countries
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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Spain
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Type of patients
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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Mild disease at enrollment
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Severity scale
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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1: Mild disease at enrollment
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Total sample size
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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132
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primary outcome
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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Death;Hospitalization;ICU admission
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Notes
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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Phase 2
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Arms
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+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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