Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Prevention and Treatment With Calcifediol of COVID-19 Coronavirus-induced Acute Respiratory Syndrome (SARS)

Conditions
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SARS-CoV 2, COVID19, SARS (Severe Acute Respiratory Syndrome), Cytokine Release Syndrome, Cytokine Storm

Intervention / Treatment
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* Drug: BAT + Calcifediol
* Drug: BAT


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Being treated with Calcifediol or Cholecalciferol in any of its presentations and dosages Intolerance or allergy to Calcifediol or its components Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control - best available therapy<br>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). | Drug: BAT<br>* 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).<br>|
| Experimental: Treatment<br>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 | Drug: BAT + Calcifediol<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission to Intensive Care Unit | Proportion of subjects who enter the Intensive Care Unit | At day 28. | 
| Death | Proportion of subjects who die. | At day 28. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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. | At day 28. | 
| Vitamin D metabolites | Evaluation of the Vitamin D metabolites. | At day 28. | 
| Evolution in SatO2 | Compare the evolution in SatO2 | At day 28. | 
| Evolution in the Sat O2/FiO2 ratio. | Compare the evolution in the Sat O2/FiO2 ratio | At day 28. | 
| Evolution in the degree of dyspnea | Compare the evolution in the degree of dyspnea using the analog Borg scale | 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 | At day 28. | 
| Incidence of adverse events | Incidence of adverse events related to medication and its administration. | At day 28. | 
| Appearance of hemorrhagic or thrombotic phenomena | Incidence in the appearance of hemorrhagic or thrombotic phenomena. | At day 28. |