The objective of the study is to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.
Phase IV, interventional, randomised, double blind, placebo-controlled and parallel study to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19. Patients will participate in the study for a maximum of 9 weeks, which includes an up to 6-week treatment period and a maximum of 3-week follow-up period. A total of 100 (50 in each group) patients will be randomized in the study and will either receive the test treatment or the placebo treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Vitamin D supplementation
Placebo comparator
CHU Liège
Liège, Belgium
Vitamin D serum concentration
Mean change from screening to end of treatment phase in 25(OH)D3 serum concentration
Time frame: Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
Clinical improvement
Ordinal scale for clinical improvement as recommended by WHO
Time frame: Baseline and up to 4 weeks after randomization on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
Hospital length of stay.
Hospital length of stay.
Time frame: at day 15 to 30 after hospital discharge
Intensive care unit length of stay.
Intensive care unit length of stay.
Time frame: at day 15 to 30 after hospital discharge
Supplemental oxygen, non-invasive or invasive ventilation or organ support
Number of patients requiring supplemental oxygen, non-invasive ventilation or high flow oxygen devices, invasive mechanical ventilation or additional organ support (pressors, renal replacement therapy, extracorporeal membrane oxygenation).
Time frame: Baseline and up to 4 weeks after randomization on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
Duration of supplemental oxygen, non-invasive or invasive ventilation or organ support
Duration of any organ support
Time frame: at day 15 to 30 after hospital discharge
Absence of fever
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Time until absence of fever for more than 48h without antipyretics.
Time frame: Last day of hospitalization, or at at day 15 to 30 after hospital discharge
Time until negative laboratory SARS-CoV-2 test.
Time until negative laboratory SARS-CoV-2 test.
Time frame: Last day of hospitalization , or at at day 15 to 30 after hospital discharge
Mortality all causes.
Mortality all causes.
Time frame: Last day of hospitalization , or at at day 15 to 30 after hospital discharge
Mortality related to Covid-19.
Mortality related to Covid-19.
Time frame: Last day of hospitalization , or at at day 15 to 30 after hospital discharge
Biological markers
Blood levels of C-reactive protein, interleukin 6 and 10, cathelicidin, white blood cells, creatinin and 1,25(OH)2-D3
Time frame: Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge