The administration of Calcifediol in patients with COVID-19, will reduce the development of SARS and the worsening of the various phases of the syndrome. Reducing at least 25% in ICU admission and death from the process, reducing days of hospitalization, facilitating the recovery of the same, acting significantly and positively, in any of its phases throughout the natural history of illness. As a treatment with extensive experience of clinical use, safe, inexpensive, and potentially very effective, it will have a highly efficient cost-benefit impact on the prevention of SARS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
517
The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS) plus Calcifediol caps. 266 µg. According to the pharmacokinetics of Calcifediol evaluated in an inflammatory model, the posology will be Start: 2 capsules Days 3, 7, 14, 21, 28: 1 capsule
The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS).
Hospital Universitario Reina Sofía
Córdoba, Spain
Admission to Intensive Care Unit
Proportion of subjects who enter the Intensive Care Unit
Time frame: At day 28.
Death
Proportion of subjects who die.
Time frame: At day 28.
Time from onset of symptoms to discharge of patients in conventional hospitalization
Compare the time (in days) at discharge in newly hospitalized patients on non-invasive ventilation.
Time frame: At day 28.
ICU - Time until admission
In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until admission to Intensive Care Unit
Time frame: At day 28.
ICU - Time mechanical ventilation is removed
In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until mechanical ventilation is removed.
Time frame: At day 28.
Evaluation of the inflammatory markers related with the disease
Evaluation of the inflammatory markers related to IL disease. Blood samples will be collected and assessed in order to evaluate interleukins related with the interleukin storm using immunological tests.
Time frame: At day 28.
Vitamin D metabolites
Evaluation of the Vitamin D metabolites.
Time frame: At day 28.
Evolution in SatO2
Compare the evolution in SatO2
Time frame: At day 28.
Evolution in the Sat O2/FiO2 ratio.
Compare the evolution in the Sat O2/FiO2 ratio
Time frame: At day 28.
Evolution in the degree of dyspnea
Compare the evolution in the degree of dyspnea using the analog Borg scale
Time frame: At day 28.
Evolution of the improvement of radiological findings by simple radiology
Compare the evolution of radiological findings by simple radiology in the recruited subjects since their beginning in the trial until they end the trial
Time frame: At day 28.
Incidence of adverse events
Incidence of adverse events related to medication and its administration.
Time frame: At day 28.
Appearance of hemorrhagic or thrombotic phenomena
Incidence in the appearance of hemorrhagic or thrombotic phenomena.
Time frame: At day 28.
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