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.
Rationale: The use of muscle ultrasound (US) is a trending method in clinical practice. It's reliable and valid for the assessment of muscle size in older adults. 1 The aim of the study is to define muscle US cut-off values for the evaluation of sarcopenia in older outpatients. Methods: A total of 400 patients (65 years) applied to geriatric outpatient clinic were assessed and 312 of them (64.5%, female) were involved. Comprehensive geriatric assessment (including frailty status), anthropometric measurements and handgrip strength (HGS) were evaluated. Rectus femoris muscle cross-sectional area (RF-CSA) was measured and cut-off values that predict low muscle strength were determined. Results:The median age was 72 (min-max, 65-93), 64.5 % were female, and 43.8 % (n¼ 137) had low HGS. 25.2% and 23.3% of patients were prefrail and frail, respectively according to Clinical Frailty Scale. RF-CSA had a good correlation with HGS (r:0.578, p<0.001). Cut-off values to predict low HGS for RF-CSA, body mass index (BMI) adjusted RF-CSA and height square adjusted RF-CSA are given in Table-1. Abbreviation: RF-CSA, rectus femoris cross-sectional area; BMI, body mass index (kg/m 2 ); AUC, area under curve; PPV, positive predictive value; NPV, negative predictive value Conclusion: The cut-off values for muscle US for the assessment of muscle mass as a part of the sarcopenia evaluation in clinical practice to guide for future studies are defined. References:
Background The impact of the variant of concern (VOC) Alpha on the severity of COVID-19 has been debated. We report our analysis in France. Methods We conducted an exposed/unexposed cohort study with retrospective data collection, comparing patients infected by VOC Alpha to contemporaneous patients infected by historical lineages. Participants were matched on age (± 2.5 years), sex and region of hospitalization. The primary endpoint was the proportion of hospitalized participants with severe COVID-19, defined as a WHO-scale > 5 or by the need of a non-rebreather mask, occurring up to day 29 after admission. We used a logistic regression model stratified on each matched pair and accounting for factors known to be associated with the severity of the disease. Results We included 650 pairs of patients hospitalized between Jan 1, 2021, and Feb 28, 2021, in 47 hospitals. Median age was 70 years and 61.3% of participants were male. The proportion of participants with comorbidities was high in both groups (85.0% vs 90%, p = 0.004). Infection by VOC Alpha was associated with a higher odds of severe COVID-19 (41.7% vs 38.5%—aOR = 1.33 95% CI [1.03–1.72]). Conclusion Infection by the VOC Alpha was associated with a higher odds of severe COVID-19.
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