Juan F Alcala-Diaz1,2, Laura Limia-Perez1, Ricardo Gomez-Huelgas3,4, Maria D Martin-Escalante5, Begoña Cortes-Rodriguez6, Jose L Zambrana-Garcia7, Marta Entrenas-Castillo8, Ana I Perez-Caballero1,2, Maria D López-Carmona3,4, Javier Garcia-Alegria5,9, Aquiles Lozano Rodríguez-Mancheño6, Maria Del Sol Arenas-de Larriva8, Luis M Pérez-Belmonte3,4, Irwin Jungreis10,11, Roger Bouillon12, Jose Manual Quesada-Gomez13, Jose Lopez-Miranda1,2. 1. Internal Medicine Department, IMIBIC/Reina Sofia University Hospital/University of Córdoba, Avda. Menéndez Pidal s/n, 14004 Córdoba, Spain. 2. CIBER Fisiopatologia Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, 28029 Madrid, Spain. 3. Internal Medicine Department, Regional University Hospital of Málaga, Avenida de Carlos Haya, s/n, 29010 Málaga, Spain. 4. Biomedical Research Institute of Málaga (IBIMA), University of Málaga (UMA), Avenida de Carlos Haya, s/n, 29010 Málaga, Spain. 5. Internal Medicine Department, Hospital Costa del Sol, Agencia Sanitaria Costa del Sol, 29603 Marbella, Málaga, Spain. 6. Internal Medicine Department, Alto Guadalquivir Hospital, Andújar, 23740 Jaén, Spain. 7. Internal Medicine Department, Hospital de Montilla, Agencia Sanitaria Alto Guadalquivir, 14550 Córdoba, Spain. 8. Pneumology Department, Reina Sofia University Hopital. Avda, Menendez Pidal s/n, 14004 Córdoba, Spain. 9. Department of Medicine, University of Málaga (UMA), Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), 29071 Málaga, Spain. 10. MIT Computer Science and Artificial Intelligence Laboratory, Cambridge, MA 02139, USA. 11. Broad Institute of MIT and Harvard, Cambridge, MA 02142, USA. 12. Laboratory of Clinical and Experimental Endocrinology, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat, ON 1/902, 3000 Leuven, Belgium. 13. IMIBIC. CIBER de Fragilidad y Envejecimiento Saludable, Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud, Avda. Menéndez Pidal s/n, 14004 Córdoba, Spain.
Abstract
CONTEXT: Calcifediol has been proposed as a potential treatment for COVID-19 patients. OBJECTIVE: To compare the administration or not of oral calcifediol on mortality risk of patients hospitalized because of COVID-19. DESIGN: Retrospective, multicenter, open, non-randomized cohort study. SETTINGS: Hospitalized care. PATIENTS: Patients with laboratory-confirmed COVID-19 between 5 February and 5 May 2020 in five hospitals in the South of Spain. INTERVENTION: Patients received calcifediol (25-hydroxyvitamin D3) treatment (0.266 mg/capsule, 2 capsules on entry and then one capsule on day 3, 7, 14, 21, and 28) or not. MAIN OUTCOME MEASURE: In-hospital mortality during the first 30 days after admission. RESULTS: A total of 537 patients were hospitalized with COVID-19 (317 males (59%), median age, 70 years), and 79 (14.7%) received calcifediol treatment. Overall, in-hospital mortality during the first 30 days was 17.5%. The OR of death for patients receiving calcifediol (mortality rate of 5%) was 0.22 (95% CI, 0.08 to 0.61) compared to patients not receiving such treatment (mortality rate of 20%; p < 0.01). Patients who received calcifediol after admission were more likely than those not receiving treatment to have comorbidity and a lower rate of CURB-65 score for pneumonia severity ≥ 3 (one point for each of confusion, urea > 7 mmol/L, respiratory rate ≥ 30/min, systolic blood pressure < 90 mm Hg or diastolic blood pressure ≤ 60 mm Hg, and age ≥ 65 years), acute respiratory distress syndrome (moderate or severe), c-reactive protein, chronic kidney disease, and blood urea nitrogen. In a multivariable logistic regression model, adjusting for confounders, there were significant differences in mortality for patients receiving calcifediol compared with patients not receiving it (OR = 0.16 (95% CI 0.03 to 0.80). CONCLUSION: Among patients hospitalized with COVID-19, treatment with calcifediol, compared with those not receiving calcifediol, was significantly associated with lower in-hospital mortality during the first 30 days. The observational design and sample size may limit the interpretation of these findings.
CONTEXT: Calcifediol has been proposed as a potential treatment for COVID-19patients. OBJECTIVE: To compare the administration or not of oral calcifediol on mortality risk of patients hospitalized because of COVID-19. DESIGN: Retrospective, multicenter, open, non-randomized cohort study. SETTINGS: Hospitalized care. PATIENTS: Patients with laboratory-confirmed COVID-19 between 5 February and 5 May 2020 in five hospitals in the South of Spain. INTERVENTION: Patients received calcifediol (25-hydroxyvitamin D3) treatment (0.266 mg/capsule, 2 capsules on entry and then one capsule on day 3, 7, 14, 21, and 28) or not. MAIN OUTCOME MEASURE: In-hospital mortality during the first 30 days after admission. RESULTS: A total of 537 patients were hospitalized with COVID-19 (317 males (59%), median age, 70 years), and 79 (14.7%) received calcifediol treatment. Overall, in-hospital mortality during the first 30 days was 17.5%. The OR of death for patients receiving calcifediol (mortality rate of 5%) was 0.22 (95% CI, 0.08 to 0.61) compared to patients not receiving such treatment (mortality rate of 20%; p < 0.01). Patients who received calcifediol after admission were more likely than those not receiving treatment to have comorbidity and a lower rate of CURB-65 score for pneumonia severity ≥ 3 (one point for each of confusion, urea > 7 mmol/L, respiratory rate ≥ 30/min, systolic blood pressure < 90 mm Hg or diastolic blood pressure ≤ 60 mm Hg, and age ≥ 65 years), acute respiratory distress syndrome (moderate or severe), c-reactive protein, chronic kidney disease, and blood ureanitrogen. In a multivariable logistic regression model, adjusting for confounders, there were significant differences in mortality for patients receiving calcifediol compared with patients not receiving it (OR = 0.16 (95% CI 0.03 to 0.80). CONCLUSION: Among patients hospitalized with COVID-19, treatment with calcifediol, compared with those not receiving calcifediol, was significantly associated with lower in-hospital mortality during the first 30 days. The observational design and sample size may limit the interpretation of these findings.
Entities:
Keywords:
COVID-19; COVID-19 drug treatment; SARS-CoV-2; calcifediol; vitamin D
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