Calcifediol treatment and COVID-19-related outcomes
Nogues X., Ovejero D., Pineda-Moncusí M., Bouillon R., Arenas D., Pascual J., Ribes A., Guerri-Fernandez R., Villar-Garcia J., Rial A., Gimenez-Argente C., Cos ML., Rodriguez-Morera J., Campodarve I., Quesada-Gomez JM., Garcia-Giralt N.
<jats:title>Abstract</jats:title> <jats:sec> <jats:title>Context</jats:title> <jats:p>COVID-19 is a major health problem because of saturation of intensive care units (ICU) and mortality. Vitamin D has emerged as a potential treatment able to reduce the disease severity.</jats:p> </jats:sec> <jats:sec> <jats:title>Objective</jats:title> <jats:p>To elucidate the effect of calcifediol [25OHD3] treatment on COVID-19-related outcomes.</jats:p> </jats:sec> <jats:sec> <jats:title>Design</jats:title> <jats:p>Observational cohort study from March to May, 2020.</jats:p> </jats:sec> <jats:sec> <jats:title>Setting</jats:title> <jats:p>Patients admitted to COVID-19 wards of Hospital del Mar, Barcelona, Spain.</jats:p> </jats:sec> <jats:sec> <jats:title>Patients</jats:title> <jats:p>A total of 930 patients with COVID-19 were included. Ninety-two were excluded due to previous calcifediol intake.</jats:p> </jats:sec> <jats:sec> <jats:title>Intervention</jats:title> <jats:p>Of the remaining 838, a total of 447 received calcifediol (532ug on day one plus 266ug on day 3, 7, 15, and 30) whereas 391 were not treated at the time of hospital admission (Intention-to-Treat). Of the latter, 53 patients were treated later during ICU admission and were allocated in the treated group in a second analysis. In healthy subjects, calcifediol is about 3.2-fold more potent on a weight basis than cholecalciferol.</jats:p> </jats:sec> <jats:sec> <jats:title>Main Outcome Measures</jats:title> <jats:p>ICU admission and mortality.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>ICU assistance was required by 102 (12.2%) participants. Out of 447 patients treated with calcifediol at admission, 20 (4.5%) required ICU, compared to 82 (21%) out of 391 non-treated (p-value&lt;0.0001). Logistic regression of calcifediol treatment on ICU admission, adjusted by age, gender, linearized 25OHD levels at baseline, and comorbidities showed that treated patients had a reduced risk to require ICU (OR 0.13 [95% CI 0.07;0.23]). Overall mortality was 10%. In the Intention-to-Treat analysis, 21 (4.7%) out of 447 patients treated with calcifediol at admission died compared to 62 patients (15.9%) out of 391 non-treated (p=0.0001). Adjusted results showed a reduced mortality risk with an OR 0.21 [95% CI 0.10; 0.43]). In the second analysis, the obtained OR was 0.52 [95% CI 0.27;0.99].</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>In patients hospitalized with COVID-19, calcifediol treatment significantly reduced ICU admission and mortality.</jats:p> </jats:sec>