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Trial - EUCTR2020-001717-20-ES


Column Value
Trial registration number EUCTR2020-001717-20-ES
Full text link
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

First author
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Fundación para la Investigación Biomédica de Córdoba - Antonio Luque

Contact
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

uicec@imibic.org

Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

2020-04-27

Recruitment status
Last imported at : Oct. 11, 2023, 4:14 a.m.
Source : EU Clinical Trials Register

Terminated

Study design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

RCT

Allocation
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Randomized

Design
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Open label

Center
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

multi-center

Study aim
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

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

Exclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

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

Number of arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

2

Funding
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Fundación para la Investigación Biomédica de Córdoba

Inclusion age min
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

90

Countries
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Spain

Type of patients
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

No restriction on type of patients

Severity scale
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

0: No restriction on type of patients

Total sample size
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

1008

primary outcome
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

1) Admission to the Intensive Care Unit or 2) Death 1) Ingreso en Unidad de Cuidados intensivos o 2) Fallecimiento

Notes
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Declared number of arm (2.0) differs from found arms (1.0)

Phase
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Phase 2

Arms
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

[{"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"}]