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| Name | Class |
|---|---|
| Junta de Andalucia | OTHER_GOV |
| Dynamic Solutions | INDUSTRY |
| Faes Farma, S.A. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - best available therapy | Active Comparator | 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). |
|
| Treatment | Experimental | 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
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT + Calcifediol | Drug | 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 |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José López Miranda, MD | Hospital General Universitario Reina SofÃa de Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina SofÃa | Córdoba | 14001 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34029377 | Derived | Stroehlein JK, Wallqvist J, Iannizzi C, Mikolajewska A, Metzendorf MI, Benstoem C, Meybohm P, Becker M, Skoetz N, Stegemann M, Piechotta V. Vitamin D supplementation for the treatment of COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 24;5(5):CD015043. doi: 10.1002/14651858.CD015043. |
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All the information will be published and accessible. It will be also available on demand.
Since the end publication of the results.
Contact uicec@imibic.org
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C038396 | glycine N-choloyltransferase |
| D002112 | Calcifediol |
| ID | Term |
|---|---|
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
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|
| BAT | Drug | 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). |
|
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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |