| Trial registration number
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NCT04366908 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04366908
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First author
Last imported at : March 8, 2023, 4 a.m.
Source : ClinicalTrials.gov
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José López Miranda
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Contact
Last imported at : March 8, 2023, 4 a.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-04-29
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Recruitment status
Last imported at : March 8, 2023, 4 a.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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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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- age ≥ 18 and < 90 years
- pcr confirmed diagnosis of covid-19. as an alternative to pcr, a determination of
antigens or any other test that in the future is considered equivalent to these in its
diagnostic value may be accepted as evidence
- radiological image compatible with inflammatory pleuropulmonary exudate or patients
with onset of symptoms in the last 7 days and with an uncomplicated respiratory
infection for outpatient follow-up.
- signature of direct or delegated informed consent
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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- being treated with calcifediol or cholecalciferol in any of its presentations and
dosages
- intolerance or allergy to calcifediol or its components
- pregnancy
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.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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Maimónides Biomedical Research Institute of Córdoba
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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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89
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Countries
Last imported at : Feb. 17, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Spain
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Moderate/severe/critical 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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5: Moderate/severe/critical disease at enrollment
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Total sample size
Last imported at : March 8, 2023, 4 a.m.
Source : ClinicalTrials.gov
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517
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Admission to Intensive Care Unit;Death
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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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 244, "treatment_name": "Calcifediol", "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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