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ALBACOVIDIOL Study: Effect of Calcifediol Treatment on Mortality in Patients Hospitalized for COVID-19: A
José Antonio Blázquez-Cabrera1, Javier Torres-Hernández2, Roger Bouillon3
1Internal Medicine Department, Complejo Hospitalario Universitario de Albacete, 02008 Albacete, Spain.
Insights
High-dose calcifediol treatment reduced mortality in hospitalized COVID-19 patients, particularly those with severe vitamin D deficiency. This immunomodulatory approach showed promising results in the ALBACOVIDIOL study.
Area of Science:
- Immunology and Infectious Diseases
- Endocrinology and Metabolism
Background:
- COVID-19 treatment involves immunomodulatory strategies to manage excessive host immune responses.
- High doses of calcifediol, a vitamin D metabolite, are investigated for their potential to reduce COVID-19 mortality.
Purpose of the Study:
- To assess the impact of high-dose calcifediol on mortality risk in hospitalized COVID-19 patients during early outbreaks.
- To evaluate calcifediol's efficacy as an adjunct therapy in patients receiving corticosteroids and/or baricitinib.
Main Methods:
- Retrospective observational study at Complejo Hospitalario Universitario de Albacete (CHUA), Spain (January-March 2021).
- Analysis of mortality rates in 230 hospitalized COVID-19 patients based on calcifediol treatment status.
- Measurement of 25(OH)D levels on admission to identify vitamin D deficiency prevalence.
Main Results:
- Calcifediol treatment was associated with a significantly lower mortality rate (12.6%) compared to no calcifediol (23.4%; OR=0.47).
- Patients with severe vitamin D deficiency (≤10 ng/mL) treated with calcifediol had 0% mortality versus 38.9% in untreated patients.
- Combined calcifediol and corticosteroid therapy showed lower mortality than corticosteroids alone or with baricitinib.
Conclusions:
- Calcifediol treatment demonstrated an association with reduced mortality in hospitalized COVID-19 patients, especially those with severe vitamin D deficiency.
- The findings suggest calcifediol's potential as an immunomodulatory agent in COVID-19 management.
- Causality cannot be definitively established due to the retrospective nature of the ALBACOVIDIOL study.
Abstract:
Background: Immunomodulatory treatments targeting excessive host immune responses favorably shifting the course of COVID-19. High doses of calcifediol may reduce the mortality of this infection. Objective: To evaluate how a high dose of calcifediol modifies the risk of death in patients hospitalized with COVID-19 during the first outbreaks. Design: A retrospective, observational study to evaluate the relationship between treatment with calcifediol and the risk of death in patients hospitalized with COVID-19 at the "Complejo Hospitalario Universitario de Albacete" (CHUA), Spain, during the months of January to March 2021. Patients were treated with corticosteroids, and some patients also received baricitinib and/or high doses of calcifediol, according to CHUA's therapeutic protocol 2021 for COVID-19. The primary outcome measure was mortality according to calcifediol treatment. Results: A total of 230 patients were included. 25(OH)D levels were measured on admission in 148 patients, showing a high prevalence of vitamin D deficiency [median 25(OH)D: 17.5 ng/mL]. Thirty-four (23%) had severe deficiency (25(OH)D ≤ 10 ng/mL). In the 119 patients (51.7%) who received in-hospital treatment with a high dose of calcifediol, the mortality rate was 12.6% (15 cases, 95% confidence interval [CI], 7.8-19.8%), while in 111 patients who did not receive treatment with calcifediol, the death rate was 23.4% (26 cases, 95% CI: 16.5-32.1%; p = 0.039). The odds ratio (OR) in treated vs. untreated patients was 0.47 (95% CI: 0.23-0.95). Among the patients admitted with severe deficiency, 16 received treatment with calcifediol, with a mortality rate of 0.0% (0 cases, 95% CI: 0.0-19.4%), while in the 18 not treated with calcifediol, a death rate of 38.9% was observed (7 cases, 95% CI: 20.3-61.4%; p = 0.008). The mortality rate was lower in patients treated with the combination of calcifediol and corticosteroids vs. those treated with corticosteroids alone (p = 0.038) and vs. those treated with corticosteroids and baricitinib (p = 0.033). Conclusions: In the ALBACOVIDIOL study, calcifediol treatment was associated with a lower observed mortality rate in hospitalized patients with COVID-19 treated with corticosteroids (with or without baricitinib), especially in those with severe vitamin D deficiency. Causality cannot be inferred due to the retrospective study design. (Public database: ClinicalTrials.gov, NCT05819918).
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