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
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Participants |
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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
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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
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Interventions |
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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
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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
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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
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)
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