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.
Drug: Cholecalciferol
Vitamin D supplementation
Other Name: D-Cure
Other: Placebo
Placebo comparator
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.
CHU Liège
Liège, Belgium