Covid19
Conditions
Brief summary
The objective of the study is to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.
Detailed description
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.
Interventions
DRUGCholecalciferol
Vitamin D supplementation
OTHERPlacebo
Placebo comparator
Sponsors
Laboratoires SMB S.A.
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female over 18 years old (18 years inclusive). * Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization. * Expected to survive for at least 96 hours after study entry. * If patient is a female of childbearing potential, patient must use an effective means of birth control (oral, intravaginal or transdermal oestrogen-progestogen combined hormonal contraceptives or intrauterine devices or sexual abstinence). * Subject or legally authorized representative understands and agrees to comply with planned study procedures. * Subject or legally authorized representative provides informed consent prior to initiation of any study procedures.
Exclusion criteria
* Women currently pregnant or breast-feeding. * Patients presenting acute impairment of renal function or nephrolithiasis. * Patients presenting hypercalcaemia and/or hypercalciuria * Patients presenting pseudohypoparathyroidism * Use of any vitamin D supplementation alone or in association at screening visit; * Use of any prohibited medication as detailed in the concomitant medication section * Patients with any sensitivity or allergy to any of the products used within this clinical trial. * Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D serum concentration | Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge | Mean change from screening to end of treatment phase in 25(OH)D3 serum concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay. | at day 15 to 30 after hospital discharge | Hospital length of stay. |
| Intensive care unit length of stay. | at day 15 to 30 after hospital discharge | Intensive care unit length of stay. |
| Supplemental oxygen, non-invasive or invasive ventilation or organ support | 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 | 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). |
| Duration of supplemental oxygen, non-invasive or invasive ventilation or organ support | at day 15 to 30 after hospital discharge | Duration of any organ support |
| Clinical improvement | 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 | Ordinal scale for clinical improvement as recommended by WHO |
| Time until negative laboratory SARS-CoV-2 test. | Last day of hospitalization , or at at day 15 to 30 after hospital discharge | Time until negative laboratory SARS-CoV-2 test. |
| Mortality all causes. | Last day of hospitalization , or at at day 15 to 30 after hospital discharge | Mortality all causes. |
| Mortality related to Covid-19. | Last day of hospitalization , or at at day 15 to 30 after hospital discharge | Mortality related to Covid-19. |
| Biological markers | Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge | Blood levels of C-reactive protein, interleukin 6 and 10, cathelicidin, white blood cells, creatinin and 1,25(OH)2-D3 |
| Absence of fever | Last day of hospitalization, or at at day 15 to 30 after hospital discharge | Time until absence of fever for more than 48h without antipyretics. |
Countries
Belgium
Outcome results
None listed