SARS-CoV 2, COVID19, SARS (Severe Acute Respiratory Syndrome), Cytokine Release Syndrome, Cytokine Storm
Conditions
Brief summary
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.
Interventions
DRUGBAT + Calcifediol
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
DRUGBAT
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).
Sponsors
Junta de Andalucia
Dynamic Solutions
Faes Farma, S.A.
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Admission to Intensive Care Unit | At day 28. | Proportion of subjects who enter the Intensive Care Unit |
| Death | At day 28. | Proportion of subjects who die. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU - Time mechanical ventilation is removed | At day 28. | In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until mechanical ventilation is removed. |
| Evaluation of the inflammatory markers related with the disease | At day 28. | 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. |
| Vitamin D metabolites | At day 28. | Evaluation of the Vitamin D metabolites. |
| Evolution in SatO2 | At day 28. | Compare the evolution in SatO2 |
| Time from onset of symptoms to discharge of patients in conventional hospitalization | At day 28. | Compare the time (in days) at discharge in newly hospitalized patients on non-invasive ventilation. |
| Evolution in the degree of dyspnea | At day 28. | Compare the evolution in the degree of dyspnea using the analog Borg scale |
| Evolution of the improvement of radiological findings by simple radiology | At day 28. | Compare the evolution of radiological findings by simple radiology in the recruited subjects since their beginning in the trial until they end the trial |
| Incidence of adverse events | At day 28. | Incidence of adverse events related to medication and its administration. |
| Appearance of hemorrhagic or thrombotic phenomena | At day 28. | Incidence in the appearance of hemorrhagic or thrombotic phenomena. |
| Evolution in the Sat O2/FiO2 ratio. | At day 28. | Compare the evolution in the Sat O2/FiO2 ratio |
| ICU - Time until admission | At day 28. | In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until admission to Intensive Care Unit |
Countries
Spain
Outcome results
None listed