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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

ABSTRACT: Highlights • The vitamin D endocrine system may have a variety of actions on cells and tissues involved in COVID-19 progression.• Administration of calcifediol or 25-hydroxyvitamin D to hospitalized COVID-19 patients significantly reduced their need for Intensive Care United admission.• Calcifediol seems to be able to reduce severity of the disease. 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?hours on the first day, and 200?mg every 12?hours 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?

SUBMITTER: Castillo M

PROVIDER: S-EPMC7456194 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo assess whether risk of severe outcomes among patients with type 1 diabetes mellitus (T1DM) hospitalized for coronavirus disease 2019 (COVID-19) differs from that of patients without diabetes or with type 2 diabetes mellitus (T2DM).Research design and methodsUsing the Premier Healthcare Database Special COVID-19 Release records of patients discharged after COVID-19 hospitalization from U.S. hospitals from March to November 2020 (N = 269,674 after exclusion), we estimated risk differences (RD) and risk ratios (RR) of intensive care unit admission or invasive mechanical ventilation (ICU/MV) and of death among patients with T1DM compared with patients without diabetes or with T2DM. Logistic models were adjusted for age, sex, and race or ethnicity. Models adjusted for additional demographic and clinical characteristics were used to examine whether other factors account for the associations between T1DM and severe COVID-19 outcomes.ResultsCompared with patients without diabetes, T1DM was associated with a 21% higher absolute risk of ICU/MV (RD 0.21, 95% CI 0.19-0.24; RR 1.49, 95% CI 1.43-1.56) and a 5% higher absolute risk of mortality (RD 0.05, 95% CI 0.03-0.07; RR 1.40, 95% CI 1.24-1.57), with adjustment for age, sex, and race or ethnicity. Compared with T2DM, T1DM was associated with a 9% higher absolute risk of ICU/MV (RD 0.09, 95% CI 0.07-0.12; RR 1.17, 95% CI 1.12-1.22), but no difference in mortality (RD 0.00, 95% CI -0.02 to 0.02; RR 1.00, 95% CI 0.89-1.13). After adjustment for diabetic ketoacidosis (DKA) occurring before or at COVID-19 diagnosis, patients with T1DM no longer had increased risk of ICU/MV (RD 0.01, 95% CI -0.01 to 0.03) and had lower mortality (RD -0.03, 95% CI -0.05 to -0.01) in comparisons with patients with T2DM.ConclusionsPatients with T1DM hospitalized for COVID-19 are at higher risk for severe outcomes than those without diabetes. Higher risk of ICU/MV in patients with T1DM than in patients with T2DM was largely accounted for by the presence of DKA. These findings might further guide recommendations related to diabetes management and the prevention of COVID-19.

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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

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