Calcifediol Treatment and COVID-19-Related Outcomes

Nogués, Xavier and Ovejero, Diana and Quesada-Gomez, J. M. and Bouillon, Roger and Arenas, Dolores and Pascual, Julio and Villar-Garcia, Judith and Rial, Abora and Gimenez-Argente, Carme and Cos, ML. and Rodriguez-Morera, Jaime and Campodarve, Isabel and Guerri-Fernandez, Robert and Pineda-Moncusí, Marta and García-Giralt, Natalia, Calcifediol Treatment and COVID-19-Related Outcomes. Available at SSRN: https://ssrn.com/abstract=3771318 or http://dx.doi.org/10.2139/ssrn.3771318

PDF: https://papers.ssrn.com/sol3/Delivery.cfm/18ede592-38f4-4dde-bfa6-d7bb7f0a3411-MECA.pdf?abstractid=3771318&mirid=1 

Abstract

Background: COVID-19 is a major health problem because of acute respiratory distress syndrome, saturation of intensive care units (ICU) and mortality.

Methods: Our study aims to elucidate the effect of calcifediol [25(OH)D3] treatment on ICU admission and mortality, in patients admitted to COVID-19 wards of Hospital del Mar, Barcelona, Spain. A total of 930 participants were included. Participants (n=551) were randomly assigned to calcifediol treatment (532 ug on day one and 266 ug on day 3, 7, 15, and 30) at the time of hospital admission or as controls (n=379).

Findings: ICU assistance was required by 110 (11.8%) participants. Out of 551 patients treated with calcifediol at admission, 30 (5.4%) required ICU, compared to 80 out of 379 controls (21.1%; p<0.0001). Logistic regression of calcifediol treatment on ICU admission, adjusted by age, gender, linearized 25(OH)D levels at baseline, and comorbidities showed that treated patients had a reduced risk to require ICU (RR 0.18 [95% CI 0.11;0.29]). Baseline 25(OH)D levels inversely correlated with the risk of ICU admission (RR 0.53 [95% CI 0.35;0.80]). Overall mortality was 10%. In the Intention-to-treat analysis, 36 (6.5%) out of 551 patients treated with calcifediol at admission died compared to 57 patients (15%) out of 379 controls (p=0.001). Adjusted results showed a reduced mortality for more of 60%. Higher baseline 25(OH)D levels were significantly associated with decreased mortality (RR 0.40 [95% CI 0.24;0.67]). Age and obesity were also predictors of mortality.

Interpretation: In patients hospitalized with COVID-19, calcifediol treatment at the time of hospitalization significantly reduced ICU admission and mortality.

Funding Statement: CIBERFES and FIS (ISCIII), and FEDER funds

Declaration of Interests: RB has small lecture or consultancy fees from Fresenius (Germany), Abiogen (Italy), Faes Farma (Spain) and Proctor & Gamble (Belgium). All other authors declare no competing interests.

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3771318