NCT04636086.

Study name	Vitamin D supplementation and Covid‐19: a randomised, double‐ blind, controlled study
Methods	Trial design: RCT Sample size: 100 Setting: inpatient Language: English (Belgium) Number of centres: 1 Type of intervention (treatment/prevention): treatment
Participants	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 randomisation 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 authorised representative understands and agrees to comply with planned study procedures Subject or legally authorised 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
Interventions	Details of intervention Dose: 9 doses of 25,000 IU/mL Route of administration: one ampoule on Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 and Day 36 (orally) Treatment details of control group (e.g dose, route of administration): placebo, same scheme Concomitant therapy: none
Outcomes	Primary study outcome vitamin D serum concentration Review outcomes All‐cause mortality at day 28, day 60, and up to longest follow‐up ‐ reported Clinical status, assessed by need for respiratory support with standardised scales (e.g. WHO Clinical Progression Scale (WHO 2020e), WHO Ordinal Scale for Clinical Improvement (WHO 2020f)) at up to 7 days, 8 to 15 days, 16 to 30 days; including: yes, reported with ordinal scale for clinical improvement as recommended by WHO Ventilator‐free days and need for intubation or IV (at day 28, day 60, and up to longest follow‐up) Weaning/liberation from mechanical ventilation Increase of WHO score (WHO clinical progression scale), for subgroup of patients without the respective need for respiratory support at baseline: reported need for invasive ventilation i.e. WHO 7‐9; need for non‐invasive ventilation or high flow i.e. WHO = 6; need for oxygen by mask or nasal prongs i.e. WHO = 5; need for hospitalisation without oxygen therapy i.e. WHO = 4 Need for dialysis (at up to 28 days) ‐ NP Quality of life, including fatigue and neurological status, assessed with standardised scales (e.g. WHOQOL‐100) at up to seven days; up to 30 days, and longest follow‐up available ‐ NP Admission to ICU ‐ NP Duration of hospitalisation ‐ NP Time to discharge from hospital ‐ NP Time to symptom resolution (defined as no need for oxygen support; WHO Scale <=4) ‐ NP Viral clearance (at day 3, 7 or 15) ‐ NP Serious adverse events, defined as number of participants with event ‐ NR Adverse events (any grade, grade 1‐2, grade 3‐4), defined as number of participants with event ‐ NR Vitamin D serum levels ‐ reported Additional review outcomes Duration of supplemental oxygen, non‐invasive or invasive ventilation or organ support Absence of fever Intensive care unit length of stay Time until negative laboratory SARS‐CoV‐2 test Mortality related to Covid‐19 Blood levels of C‐reactive protein, interleukin 6 and 10, cathelicidin, white blood cells, creatinine and 1,25(OH)2‐D3
Starting date	November 12, 2020
Contact information	Contact: Anne‐Françoise Rousseau, MD, PhD +3243667495 afrousseau@chuliege.be
Notes	Recruitment status: recruiting Prospective completion date: 28/02/2021 Date last update was posted: 19/11/2020 Sponsor/funding: University of Liege