Effect of Vitamin D on Hospitalized Adults With COVID-19 Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vitamin D Supplementation and Covid-19: a Randomised, Double- Blind, Controlled Study

Conditions
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Covid19

Intervention / Treatment
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* Drug: Cholecalciferol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test treatment<br>Test Treatment: Ampoule for enteral use containing 25,000 IU/mL of cholecalciferol taken according to the following scheme: one ampoule on Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 and Day 36. | Drug: Cholecalciferol<br>* Vitamin D supplementation<br>* Other names: D-Cure;|
| Placebo Comparator: Placebo treatment<br>Placebo Treatment: Ampoule of placebo for enteral use containing excipient only taken according to the following scheme: one ampoule on Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 and Day 36. | Other: Placebo<br>* Placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D serum concentration | Mean change from screening to end of treatment phase in 25(OH)D3 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | Ordinal scale for clinical improvement as recommended by WHO | 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. | at day 15 to 30 after hospital discharge | 
| Intensive care unit length of stay. | Intensive care unit length of stay. | 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). | 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 | at day 15 to 30 after hospital discharge | 
| Absence of fever | Time until absence of fever for more than 48h without antipyretics. | 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. | Last day of hospitalization , or at at day 15 to 30 after hospital discharge | 
| Mortality all causes. | Mortality all causes. | Last day of hospitalization , or at at day 15 to 30 after hospital discharge | 
| Mortality related to Covid-19. | Mortality related to Covid-19. | 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 | Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge |