Evaluation of the likely beneficial effects of vitamin D on infection with coronavirus.

Phase 1

Active, not recruiting

• Conditions: SARS-COV-2 infection; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002274-28-ES
• Lead Sponsor: Fundación para la Investigación y la Innovación Biosanitaria del Principado de Asturias (FINBA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-21
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients treated in the ER or admitted to the HUCA Hospitalization unit.
• Diagnosis of COVID19 demonstrated by positive PCR for SARS COV2 prior to randomization.
• Age> = 18 years.
• That they have accepted to participate in the study through informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

• When discharge or a fatal outcome is expected within the next 48 hours.
• Obvious cognitive impairment (inability to communicate).
• PCR for SARS-COV 2 negative despite radiological, analytical and clinical findings compatible with this type of infection.
• Allergy to vitamin D.
• Patients who are receiving, or have received in the past 3 months, any form of vitamin D
• Pregnant women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to analyze if the administration of a single dose of native vitamin D (100,000 IU of Colecalciferol) (1 ampoule of 100,000) has an influence on the evolution of clinical and biochemical parameters of the disease.;Secondary Objective: Not applicable;Primary end point(s): • Percentage and time of patients who have a negative SARS-CoV-2 viral load<br>• Clinical symptoms and time during hospitalization<br>• Improvement of biochemical and molecular parameters of inflammation<br>• Overall mean hospital stay<br>• Percentage of patients requiring transfer to the ICU<br>• Average stay in ICU<br>• Mortality during follow-up;Timepoint(s) of evaluation of this end point: 14 and 21 days or until a negative SARS-CoV-2 test every 7 days.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A