A single-oral bolus of 100,000 IU of cholecalciferol at hospital admission did not improve outcomes in the COVID-19 disease: the COVID-VIT-D-a randomised multicentre international clinical trial.

BACKGROUND: Vitamin D status has been implicated in COVID-19 disease. The objective of the COVID-VIT-D trial was to investigate if an oral bolus of cholecalciferol (100,000 IU) administered at hospital admission influences the outcomes of moderate-severe COVID-19 disease. In the same cohort, the association between baseline serum calcidiol levels with the same outcomes was also analysed. METHODS: The COVID-VIT-D is a multicentre, international, randomised, open label, clinical trial conducted throughout 1 year. Patients older than 18 years with moderate-severe COVID-19 disease requiring hospitalisation were included. At admission, patients were randomised 1:1 to receive a single oral bolus of cholecalciferol (n=274) or nothing (n=269). Patients were followed from admission to discharge or death. Length of hospitalisation, admission to intensive care unit (ICU) and mortality were assessed. RESULTS: In the randomised trial, comorbidities, biomarkers, symptoms and drugs used did not differ between groups. Median serum calcidiol in the cholecalciferol and control groups were 17.0 vs. 16.1 ng/mL at admission and 29.0 vs. 16.4 ng/mL at discharge, respectively. The median length of hospitalisation (10.0 [95%CI 9.0-10.5] vs. 9.5 [95%CI 9.0-10.5] days), admission to ICU (17.2% [95%CI 13.0-22.3] vs. 16.4% [95%CI 12.3-21.4]) and death rate (8.0% [95%CI 5.2-12.1] vs. 5.6% [95%CI 3.3-9.2]) did not differ between the cholecalciferol and control group. In the cohort analyses, the highest serum calcidiol category at admission (>25ng/mL) was associated with lower percentage of pulmonary involvement and better outcomes. CONCLUSIONS: The randomised clinical trial showed the administration of an oral bolus of 100,000 IU of cholecalciferol at hospital admission did not improve the outcomes of the COVID-19 disease. A cohort analysis showed that serum calcidiol at hospital admission was associated with outcomes. TRIAL REGISTRATION: COVID-VIT-D trial was authorised by the Spanish Agency for Medicines and Health products (AEMPS) and registered in European Union Drug Regulating Authorities Clinical Trials (EudraCT 2020-002274-28) and in ClinicalTrials.gov ( NCT04552951 ).

Coronavirus Disease 2019 in Patients With End-Stage Kidney Disease on Hemodialysis in Guatemala.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) is public health concern across the world. Data on the epidemiology among patients on hemodialysis in Latin America and low- and middle-income countries are limited. METHODS: Using electronic medical records from the second largest dialysis network in Guatemala, we performed a retrospective analysis of all adult patients on hemodialysis with the diagnosis of COVID-19 to estimate incidence of infection and to describe the demographics, comorbidities, and outcomes. We stratified incidence rate by region. We reviewed data from May 1 to July 31, 2020, with outcome data ascertained up to August 28, 2020. RESULTS: Of 3201 patients undergoing hemodialysis, 325 patients were diagnosed with COVID-19 (incidence rate 102/1000 patients on hemodialysis, compared with 3/1000 in the general population). Incidence was higher in the Central region (207/1000) and lowest in the Southeast region (33/1000), and unlike in the general population, the incidence was lower in Guatemala City. The mean age of patients diagnosed with COVID-19 was 51.1 years (standard deviation [SD] 14.8 years), and 84 (25.8%) were female. The median length of hospital stay was 12 days (interquartile range [IQR] 10-16 days). Two hundred twenty-nine (69.8%) of the patients recovered, 90 patients died (27.7%), and 6 (1.8%) patients were still in the hospital at the time of last follow-up. CONCLUSION: The incidence of diagnosed COVID-19 in Guatemalan patients on hemodialysis was much higher than reported in the general population, with outcomes similar to those described in high-income countries. Rural regions had higher incidence rates than the major metropolitan area.