Background With the lack of effective therapy, chemoprevention, and vaccination against SARS-CoV-2, focusing on the immediate repurposing of existing drugs gives hope of curbing the COVID-19 pandemic. A recent unbiased genomics-guided tracing of the SARS-CoV-2 targets in human cells identified vitamin D among the three top-scoring molecules manifesting potential infection mitigation patterns. Growing pre-clinical and epidemiological observational data support this assumption. We hypothesized that vitamin D supplementation may improve the prognosis of COVID-19. The aim of this trial is to compare the effect of a single oral high dose of cholecalciferol versus a single oral standard dose on all-cause 14-day mortality rate in COVID-19 older adults at higher risk of worsening. Methods The COVIT-TRIAL study is an open-label, multicenter, randomized controlled superiority trial. Patients aged ≥ 65 years with COVID-19 (diagnosed within the preceding 3 days with RT-PCR and/or chest CT scan) and at least one worsening risk factor at the time of inclusion (i.e., age ≥ 75 years, or SpO2 ≤ 94% in room air, or PaO2/FiO2 ≤ 300 mmHg), having no contraindications to vitamin D supplementation, and having received no vitamin D supplementation > 800 IU/day during the preceding month are recruited. Participants are randomized either to high-dose cholecalciferol (two 200,000 IU drinking vials at once on the day of inclusion) or to standard-dose cholecalciferol (one 50,000 IU drinking vial on the day of inclusion). Two hundred sixty participants are recruited and followed up for 28 days. The primary outcome measure is all-cause mortality within 14 days of inclusion. Secondary outcomes are the score changes on the World Health Organization Ordinal Scale for Clinical Improvement (OSCI) scale for COVID-19, and the between-group comparison of safety. These outcomes are assessed at baseline, day 14, and day 28, together with the serum concentrations of 25(OH)D, creatinine, calcium, and albumin at baseline and day 7. Discussion COVIT-TRIAL is to our knowledge the first randomized controlled trial testing the effect of vitamin D supplementation on the prognosis of COVID-19 in high-risk older patients. High-dose vitamin D supplementation may be an effective, well-tolerated, and easily and immediately accessible treatment for COVID-19, the incidence of which increases dramatically and for which there are currently no scientifically validated treatments. Trial registration ClinicalTrials.govNCT04344041. Registered on 14 April 2020 Trial status Recruiting. Recruitment is expected to be completed in April 2021.

Background: The significant risk of adverse events following medical procedures supports a clinical epidemiological approach based on the analyses of collections of electronic medical records. Data analytical tools might help clinical epidemiologists develop more appropriate case-crossover designs for monitoring patient safety.Objective: To develop and assess the methodological quality of an interactive tool for use by clinical epidemiologists to systematically design case-crossover analyses of large electronic medical records databases.Material and Methods: We developed IT-CARES, an analytical tool implementing case-crossover design, to explore the association between exposures and outcomes. The exposures and outcomes are defined by clinical epidemiologists via lists of codes entered via a user interface screen. We tested IT-CARES on data from the French national inpatient stay database, which documents diagnoses and medical procedures for 170 million inpatient stays between 2007 and 2013. We compared the results of our analysis with reference data from the literature on thromboembolic risk after delivery and bleeding risk after total hip replacement.Results: IT-CARES provides a user interface with 3 columns: (i) the outcome criteria in the left-hand column, (ii) the exposure criteria in the right-hand column, and (iii) the estimated risk (odds ratios, presented in both graphical and tabular formats) in the middle column. The estimated odds ratios were consistent with the reference literature data.Discussion: IT-CARES may enhance patient safety by facilitating clinical epidemiological studies of adverse events following medical procedures. The tool’s usability must be evaluated and improved in further research.

OBJECTIVES: To describe and compare survival among patients with out-of-hospital cardiac arrest as a function of their status for coronavirus disease 2019. DESIGN: We performed an observational study of out-of-hospital cardiac arrest patients between March 2020 and December 2020. Coronavirus disease 2019 status (confirmed, suspected, or negative) was defined according to the World Health Organization’s criteria. SETTING: Information on the patients and their care was extracted from the French national out-of-hospital cardiac arrest registry. The French prehospital emergency medical system has two tiers: the fire department intervenes rapidly to provide basic life support, and mobile ICUs provide advanced life support. The study data (including each patient’s coronavirus disease 2019 status) were collected by 95 mobile ICUs throughout France. PATIENTS: We included 6,624 out-of-hospital cardiac arrest patients: 127 cases with confirmed coronavirus disease 2019, 473 with suspected coronavirus disease 2019, and 6,024 negative for coronavirus disease 2019. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The “confirmed” and “suspected” groups of coronavirus disease 2019 patients had similar characteristics and were more likely to have suffered an out-of-hospital cardiac arrest with a respiratory cause (confirmed: 53.7%, suspected coronavirus disease 2019: 56.5%; p = 0.472) than noncoronavirus disease 2019 patients (14.0%; p < 0.001 vs confirmed coronavirus disease 2019 patients). Advanced life support was initiated for 57.5% of the confirmed coronavirus disease 2019 patients, compared with 64.5% of the suspected coronavirus disease 2019 patients ( p = 0.149) and 70.6% of the noncoronavirus disease 2019 ones ( p = 0.002). The survival rate at 30-day postout-of-hospital cardiac arrest was 0% in the confirmed coronavirus disease 2019 group, 0.9% in the suspected coronavirus disease 2019 group ( p = 0.583 vs confirmed), and 3.5% ( p = 0.023) in the noncoronavirus disease 2019 group. CONCLUSIONS: Our results highlighted a zero survival rate in out-of-hospital cardiac arrest patients with confirmed coronavirus disease 2019. This finding raises important questions with regard to the futility of resuscitation for coronavirus disease 2019 patients and the management of the associated risks.

Introduction: Malnutrition and nutrition-related diseases are associated with hospital admissions, disability, institutionalization, and mortality in older people. Specialists in Geriatric Medicine and nutrition evaluate nutritional status as part of the comprehens ive geriatric assessment; however, malnutrition still remains under-recognized and undermanaged. Our survey explored nutrition assessment approaches used in daily clinical practice by geriatricians across Europe. Methods: A 19-item survey on methods and instruments for malnutrition assessment in geriatric settings, and details of any national guidelines, was sent to 40 postgraduate fellows of the European Academy of Medicine of Ageing (EAMA, 2017-2019 class).Results: Thirty-six of the 40 eligible EAMA participants, representing 14 European countries, responded. In clinical practice, MNA and MNA-SF were most frequently used for screening (44.1%, 52.9%, respectively) and diagnosing (45.7%, 40.0%) malnutrition. Weight loss (n=36, 100%), body mass index (n=30, 85.7%), and low energy/food intake (n=27, 77.1%) were the most frequent clinical variables considered. The absolute and relative amount of weight loss, and over what time period, varied widely. These routinely considered clinical factors contribute to validated GLIM, ASPEN-AND and ESPEN criteria for diagnosis of malnutrition, but these criteria were seldom used (GLIM=0%, ASPEN=0%; n=9, ESPEN=25.7%). National guidelines were available in 9 of the 14 countries, and generally recommended MNA and MNA-SF for community-dwelling and hospitalized older patients. Albumin was often suggested as a nutritional marker. HighlightsNutritional assessment performed by geriatricians in clinical practice varies widely across European countries.

The underuse of OAC is associated with the prescription of APT in older patients with AF, regardless of the presence or absence of known atheromatous disease. Our results suggest that APT is often inappropriately prescribed instead of OAC.