NCT04411446.

Study name	Randomized controlled trial of high dose of vitamin D as compared with placebo to prevent complications among COVID‐19 patients
Methods	Trial design: RCT Sample size: 1264 Setting: inpatient Language: English (Argentina) Number of centres: 1 Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria SARS‐CoV‐2 confirmed infection Admission to a hospital Expected hospitalisation in the centre for at least for 24 hours Oxygen Saturation > 90% breathing without oxygen supplement Age at least 45 years or the presence of one of the followings risk factors Hypertension Diabetes (type I o II) At least moderate COPD or Asthma Cardiovascular disease (history of myocardial infarction, coronary angioplasty, coronary artery bypass grafting or valve replacement surgery) Body Mass Index >=30 Signed Written consent Exclusion criteria < 18 years old Women in childbearing age >= 72 hours since current admission Requirement for high dose of oxygen (>5 liters/minute) or mechanical ventilation (non‐invasive or invasive) History of Chronic kidney disease requiring hemodialysis or chronic liver failure Inability for oral intake Previous treatment with pharmacological vitamin D History of: previous treatment with anticonvulsants; sarcoidosis; malabsorption syndrome; Known hypercalcemia Life expectancy less than 6 months Known allergy to the study medication Any condition impeding to bring informed consent
Interventions	Details of intervention Dose: 5 capsules of 100,000 IU Vitamin D given all at once. One dose. Route of administration: oral Treatment details of control group (e.g dose, route of administration): 5 capsules of containing placebo given all at once (p.o.). One dose. Concomitant therapy: none
Outcomes	Primary study outcome Respiratory SOFA score Need of high dose oxygen or medical ventilation Review outcomes All‐cause mortality at day 28, day 60, time‐to‐event, and at hospital discharge ‐ 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 day 28, day 60, and up to longest follow‐up); including: Improvement of clinical status: weaning or liberation from invasive mechanical ventilation in surviving patients i.e. WHO ≤6, if ≥7 at baseline; ventilator free days; ventilator free defined as WHO ≤6; duration to liberation from invasive mechanical ventilation; liberation from supplemental oxygen in surviving patients i.e. WHO ≤4, if ≥5 at baseline; duration to liberation from supplemental oxygen. Worsening of clinical status: need for invasive mechanical ventilation i.e. WHO 7‐9, if ≤6 at baseline; need for non‐invasive mechanical ventilation or high flow i.e. WHO=6, if ≤5 at baseline; need for oxygen by mask or nasal prongs i.e. WHO=5, if ≤4 at baseline. Probably reported Need for dialysis (at up to 28 days) ‐ probably reported 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 ‐ reported Duration of hospitalisation ‐ reported Time to discharge from hospital ‐ NP Viral clearance, assessed with reverse transcription polymerase chain reaction (RT‐PCR) test for SARS‐CoV‐2 at baseline, up to 3, 7, and 15 days ‐ NP Vitamin D serum levels ‐ NP Serious adverse events, defined as number of participants with event ‐ NP Adverse events (any grade, grade 1‐2, grade 3‐4), defined as number of participants with event ‐ NP Additional study outcomes Change in oxygen saturation Oxygen desaturation Change in Quick SOFA score Myocardial infarction Stroke Acute kidney injury Pulmonary thromboembolism Combined endpoint (stroke, myocardial infarct, acute kidney injury, pulmonary thromboembolism) Admission to ICU Invasive mechanical ventilation Hospital length of stay ICU length of stay Death (30 days or discharge)
Starting date	11/08/2020
Contact information	Javier Mariani, MD +541142109000 ext 1523 ja_mariani@hotmail.com
Notes	Recruitment status: recruiting Prospective completion date: 28/12/2020 Protocol published: 1 February 2021 Anticipated recruitment completion for the first stage in mid‐February, 2021, and in August, 2021 for the second stage Sponsor/funding: Vitamin D study group