COVID-19
Conditions
Brief summary
Patients diagnosed of COVID-19 disease are randomized to receive a single dose of 100.000 IU of Cholecalciferol (Vitamin D arm) or no vitamin D (on top of the current medication used to treat COVID 19). Clinical, radiological and biochemical outcomes of COVID 19 disease as well as mortality are evaluated.
Detailed description
Efficacy parameters to compare both groups (vitamin D and No vitamin D). Time to reach undetectable levels of SARS COV2 Infection. Time of normalization of symptoms and clinical parameters. Time of normalization of radiological images. Time of normalization of biochemical markers. Time of normalization of molecular inflammatory markers. Transfer to the Intensive care Unit. Mortality rate.
Interventions
DRUGCholecalciferol
Single doe of 100.000 IU
Sponsors
Hospital Universitario Central de Asturias
Instituto de Investigación Sanitaria del Principado de Asturias
Fundación para la Investigación Biosanitaria del Principado de Asturias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Patients receiving any form. of vitamin D excluded from the study. Randomized study (Initial serum calcidiol levels blinded )
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* \> 18 year * Diagnosis of COVID-19 * Accept to participate in the study ( consent)
Exclusion criteria
* Pregnancy * Allergy to vitamin D * Consumption of any form of vitamin D during the last 3 months * Expected fatal outcome in the next 24 hours * Cognitive deterioration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calcidiol changes | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | Calcidiol levels in ng/mL. |
| Inflammation markers changes (CRP) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | C-reactive protein (CRP) in mg/L |
| Inflammation markers changes (IL-6) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | Interleukin-6 (IL-6) in pg/mL |
| Inflammation markers changes (Leucocytes) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | Leucocytes in cells per liter |
| Inflammation markers changes (D-dimer) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | D-dimer in µg/mL |
| General biochemical parameters changes (Creatinine) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | Creatinine in mg/dL |
| Mortality | Time to death or hospital discharge in days (average 12 days) | Percentage of patients dying during hospitalization |
| Admission to Intensive Care Unit (ICU) | Time from hospital admission to discharge in days (average 12 days) | Percentage of patients admitted to ICU and time in ICU |
| Time of hospitalization | Time of hospitalization in days (average 12 days) | Number of days from hospital admission to discharge |
| Clinical changes | At the time of hospital admission and discharge (average 12 days) | Percentage of patients with symptoms after treatment (Cough, fever, headache, weakness, dyspnoea, anosmia, diarrhoea, ageusia, others ...) |
| Radiological changes | At the time of hospital admission and discharge (average 12 days) | Changes in the percentage of patients with radiological findings of pneumonia and severity |
| General biochemical parameters changes (Ferritin) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | Ferritin in µg/L |
| General biochemical parameters changes (Bilirubin) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | Bilirubin in mg/dL |
| General biochemical parameters changes (Albumin) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | Albumin in g/dL |
| General biochemical parameters changes (Haemoglobin) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | Haemoglobin in g/dL |
| General biochemical parameters changes (HDL cholesterol) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | High density lipoprotein (HDL cholesterol) in mg/dL |
| General biochemical parameters changes (Procalcitonin) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | Procalcitonin in ng/mL |
| General biochemical parameters changes (Protonin) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | Protonin in ng/L |
| General biochemical parameters changes (Calcium) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | Calcium in mg/dL |
| General biochemical parameters changes (Phosphate) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | Phosphate in mg/dL |
| General biochemical parameters changes (pO2) | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | pO2 in mmHg |
Countries
Spain
Contacts
Primary ContactJorge B Cannata-Andía, MD PhD
Backup ContactJuan Pérez-Ortega
Outcome results
None listed