Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/3215
Título : 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.
Autor : Entrenas Castillo, Marta
Entrenas Costa, Luis Manuel
Vaquero Barrios, José Manuel
Alcalá Díaz, Juan Francisco
López Miranda, José
Bouillon, Roger
Quesada Gomez, José Manuel
Filiación: [Entrenas Castillo,M; Entrenas Costa,LM; Vaquero Barrios,JM] UGC de Neumología, Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Córdoba, Spain. [Alcalá Díaz,JF; López Miranda,J] Departamento de Medicina Interna. IMIBIC, CIBER de Fisiopatología de la Obesidad y la Nutrición. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Córdoba, Spain. [Bouillon] Department of Chronic Diseases, Metabolism and Ageing, Laboratory of Clinical and Experimental Endocrinology, KU Leuven, Leuven, Belgium. [Quesada Gomez,JM] IMIBIC. CIBER de Fragilidad y Envejecimiento Saludable. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Córdoba, Spain.
Palabras clave : COVID-19
SARS-CoV-2
Vitamin D
Vitamin D3 or calcitriol
Calcifediol or 25-hydroxyvitamin D3
1α, 25(OH)2D or 1α, 25-dihydroxyvitamin D or calcitriol
Acute respiratory distress syndrome (ARDS)
Cytokine/Chemokine storm
Renin-angiotensin system
Hypercoagulability
Hydroxychloroquine
Chloroquine
Covidiol
Neutrophil activity
Vitamin D endocrine system
Cuboidal alveolar coating cells type II
Cathelicidin peptide
Defensins
TLR co-receptor CD14
Vitamin D receptor
MeSH: Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Bone Density Conservation Agents
Medical Subject Headings::Chemicals and Drugs::Polycyclic Compounds::Steroids::Secosteroids::Vitamin D::Cholecalciferol::Hydroxycholecalciferols::Calcifediol
Medical Subject Headings::Diseases::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Double-Blind Method
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Patient Care::Hospitalization
Medical Subject Headings::Check Tags::Female
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Check Tags::Male
Medical Subject Headings::Health Care::Health Care Facilities, Manpower, and Services::Health Facilities::Hospital Units::Intensive Care Units
Medical Subject Headings::Persons::Persons::Age Groups::Adult::Middle Aged
Medical Subject Headings::Health Care::Environment and Public Health::Public Health::Disease Outbreaks::Epidemics::Pandemics
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Pilot Projects
Medical Subject Headings::Diseases::Respiratory Tract Diseases::Respiratory Tract Infections::Pneumonia
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis
Fecha de publicación : 29-Aug-2020
Editorial : Elsevier Ltd.
Cita Bibliográfica: 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.
Abstract: Objective: 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. Design: Parallel pilot randomized open label, double-masked clinical trial. Setting: 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). Procedures: 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. Results: 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 < 0.001. Univariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment versus without Calcifediol treatment: 0.02 (95 %CI 0.002-0.17). Multivariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment vs Without Calcifediol treatment ICU (adjusting by Hypertension and T2DM): 0.03 (95 %CI: 0.003-0.25). Of the patients treated with calcifediol, none died, and all were discharged, without complications. The 13 patients not treated with calcifediol, who were not admitted to the ICU, were discharged. Of the 13 patients admitted to the ICU, two died and the remaining 11 were discharged. Conclusion: 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.
URI: http://hdl.handle.net/10668/3215
Versión del editor : https://www.sciencedirect.com/science/article/pii/S0960076020302764?via%3Dihub
DOI: 0.1016/j.jsbmb.2020.105751
ISSN : 0960-0760 (Print)
Appears in Collections:01- Artículos - Hospital Reina Sofía
01- Artículos - IMIBIC. Instituto Maimónides de Investigación Biomédica de Córdoba

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