RT Journal Article
T1 "Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study".
A1 Entrenas Castillo, Marta
A1 Entrenas Costa, Luis Manuel
A1 Vaquero Barrios, Jose Manuel
A1 Alcala Diaz, Juan Francisco
A1 Lopez Miranda, Jose
A1 Bouillon, Roger
A1 Quesada Gomez, Jose Manuel
K1 1α, 25(OH)2D or 1α, 25-dihydroxyvitamin D or calcitriol
K1 Acute respiratory distress syndrome (ARDS)
K1 COVID-19
K1 Calcifediol or 25-hydroxyvitamin D3
K1 Cathelicidin peptide
K1 Chloroquine
K1 Covidiol
K1 Cuboidal alveolar coating cells type II
K1 Cytokine/Chemokine storm
K1 Defensins
K1 Hydroxychloroquine
K1 Hypercoagulability
K1 Neutrophil activity
K1 Renin-angiotensin system
K1 SARS-CoV-2
K1 TLR co-receptor CD14
K1 Vitamin D
K1 Vitamin D endocrine system
K1 Vitamin D receptor
K1 Vitamin D3 or cholecalciferol
AB The vitamin D endocrine system may have a variety of actions on cells and tissues involved in COVID-19 progression especially by decreasing the Acute Respiratory Distress Syndrome. Calcifediol can rapidly increase serum 25OHD concentration. We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19. Parallel pilot randomized open label, double-masked clinical trial. University hospital setting (Reina Sofia University Hospital, Córdoba Spain.) PARTICIPANTS: 76 consecutive patients hospitalized with COVID-19 infection, clinical picture of acute respiratory infection, confirmed by a radiographic pattern of viral pneumonia and by a positive SARS-CoV-2 PCR with CURB65 severity scale (recommending hospital admission in case of total score > 1). All hospitalized patients received as best available therapy the same standard care, (per hospital protocol), of a combination of hydroxychloroquine (400 mg every 12 h on the first day, and 200 mg every 12 h for the following 5 days), azithromycin (500 mg orally for 5 days. Eligible patients were allocated at a 2 calcifediol:1 no calcifediol ratio through electronic randomization on the day of admission to take oral calcifediol (0.532 mg), or not. Patients in the calcifediol treatment group continued with oral calcifediol (0.266 mg) on day 3 and 7, and then weekly until discharge or ICU admission. Outcomes of effectiveness included rate of ICU admission and deaths. Of 50 patients treated with calcifediol, one required admission to the ICU (2%), while of 26 untreated patients, 13 required admission (50 %) p value X2 Fischer test p  Our pilot study demonstrated that administration of a high dose of Calcifediol or 25-hydroxyvitamin D, a main metabolite of vitamin D endocrine system, significantly reduced the need for ICU treatment of patients requiring hospitalization due to proven COVID-19. Calcifediol seems to be able to reduce severity of the disease, but larger trials with groups properly matched will be required to show a definitive answer.
YR 2020
FD 2020-08-24
LK http://hdl.handle.net/10668/16186
UL http://hdl.handle.net/10668/16186
LA en
NO Entrenas Castillo M, Entrenas Costa LM, Vaquero Barrios JM, Alcalá Díaz JF, López Miranda J, Bouillon R, et al. "Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study". J Steroid Biochem Mol Biol. 2020 Oct;203:105751
NO Jose Manuel Quesada Gomez y Luis Manuel Entrenas costa had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. We acknowledge the dedication, commitment, and sacrifice of the staff, and personnel in our institution through the Covid-19 crisis and the suffering and loss of our patients as well as in their families and our Community. We appreciate the statistical work of Ipek Guler, and Carmen Molina. We are grateful to COVID-011-2020 “Programa de Investigacion ´ clínica en COVID-19 de Andalucía”. Consejería de Salud y Familia. “Fundación Progreso y Salud” and “Fundación para la Investigacion ´ Biomédica de Cordoba ´ ” (FIBICO). Andalucía. Spain.
DS RISalud
RD Apr 20, 2025