Trial registration number
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EUCTR2020-001717-20-ES |
Full text link
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001717-20/ES
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First author
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Fundación para la Investigación Biomédica de Córdoba - Antonio Luque
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Contact
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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uicec@imibic.org
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Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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2020-04-27
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Recruitment status
Last imported at : Oct. 11, 2023, 4:14 a.m.
Source : EU Clinical Trials Register
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Terminated
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Study design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Randomized
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Design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Open label
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Center
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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multi-center
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Study aim
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Treatment
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Inclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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1. Age ≥ 18 and <90 years
2. Diagnosis confirmed by COVID-19 PCR
3. Radiological image compatible with inflammatory pleuropulmonary exudate
4. Signature of direct or delegated informed consent
1. Edad ≥ 18 y < 90 años
2. Diagnostico confirmado mediante PCR de COVID-19
3. Imagen radiológica compatible con exudado pleuropulmonar inflamatorio
4. Firma de consentimiento informado directo o delegado
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Exclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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1. Being on treatment with Calcifediol or Colecalciferol in any of its presentations and dosage
2. Intolerance or allergy to Calcifediol or its components
3. Pregnancy
1. Estar en tratamiento con Calcifediol o Colecalciferol en cualquiera de sus presentaciones y posologías
2. Intolerancia o alergia a Calcifediol o sus componentes
3. Embarazo
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Number of arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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2
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Funding
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Fundación para la Investigación Biomédica de Córdoba
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Inclusion age min
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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90
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Countries
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Spain
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Type of patients
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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No restriction on type of patients
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Severity scale
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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0: No restriction on type of patients
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Total sample size
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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1008
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primary outcome
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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1) Admission to the Intensive Care Unit or
2) Death
1) Ingreso en Unidad de Cuidados intensivos o
2) Fallecimiento
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Notes
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Declared number of arm (2.0)
differs from found arms (1.0)
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Phase
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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Phase 2
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Arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register
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[{"arm_notes": "", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "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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