EUCTR2020‐002274‐28‐ES.

Study name	Usefulness of vitamin D on morbidity and mortality of SARS‐COV‐2 virus infection (Covid‐19) at the Central University Hospital of Asturias
Methods	Trial design: RCT, non‐controlled Sample size: 60 Setting: inpatient Language: English / Spanish (Spain) Number of centres: NI Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Patients treated in the ER or admitted to the HUCA Hospitalisation unit Diagnosis of COVID19 demonstrated by positive PCR for SARS COV2 prior to randomisation Age> = 18 years That they have accepted to participate in the study through informed consent Exclusion criteria When discharge or a fatal outcome is expected within the next 48 hours Obvious cognitive impairment (inability to communicate) PCR for SARS‐COV 2 negative despite radiological, analytical and clinical findings compatible with this type of infection Allergy to vitamin D Patients who are receiving, or have received in the past 3 months, any form of vitamin D Pregnant women
Interventions	Details of intervention Dose: 100,000 IU of native Vitamin D3 (calcifediol) (1 dose) Route of administration: oral solution in sachet Treatment details of control group (e.g. dose, route of administration): NR Concomitant therapy: none
Outcomes	Primary study outcome: (14 and 21 days or until a negative SARS‐CoV‐2 test every 7 days) Percentage and time of patients who have a negative SARS‐CoV‐2 viral load Clinical symptoms and time during hospitalisations Improvement of biochemical and molecular parameters of inflammation Overall mean hospital stay Percentage of patients requiring transfer to the ICU Average stay in ICU Mortality during follow‐up Review outcomes All‐cause mortality at day 28, day 60, time‐to‐event, and at hospital discharge: reported at day 21 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: NP 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 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: reported Duration of hospitalisation: reported Time to discharge from hospital: reported 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: reported Vitamin D serum levels: reported 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:
Starting date	2020‐05‐21
Contact information	Avenida Hospital Universitario s/n: enrique.caso@gmail.com
Notes	Recruitment status: ongoing Prospective completion date: NR Date last update was posted: NR Sponsor/funding: Fundación para la Investigación y la Innovación Biosanitaria del Principado de Asturias (FINBA)