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 Mucosal antibodies can prevent virus entry and replication in mucosal epithelial cells and hence virus shedding. Parenteral booster injection of a vaccine against a mucosal pathogen promotes stronger mucosal immune responses following prior mucosal infection compared to injections of a parenteral vaccine in a mucosally naive subject. We investigated whether this was also the case for the BNT162b2 COVID-19 mRNA vaccine. Methods Twenty recovered COVID-19 subjects (RCS) and 23 SARS-CoV-2 naive subjects were vaccinated with respectively one and two doses of the BNT162b2 COVID-19 vaccine. Nasal Epithelial Lining Fluid (NELF) and plasma were collected before and after vaccination and assessed for Immunoglobulin (Ig)G and IgA antibody levels to Spike and for their ability to neutralize binding of Spike to ACE-2 receptor. Blood was analyzed one week after vaccination for the number of Spike-specific Antibody Secreting Cells (ASCs) with a mucosal tropism. Results All RCS had both nasal and blood SARS-CoV-2 specific antibodies at least 90 days after initial diagnosis. In RCS, a single dose of vaccine amplified pre-existing Spike-specific IgG and IgA antibody responses in both NELF and blood against both vaccine homologous and variant strains, including delta. These responses were associated with Spike-specific IgG and IgA ASCs with a mucosal tropism in blood. Nasal IgA and IgG antibody responses were lower in magnitude in SARS-CoV-2 naive subjects after two vaccine doses compared to RCS after one dose. Conclusion Mucosal immune response to the SARS-CoV-2 Spike protein is higher in RCS after a single vaccine dose compared to SARS-CoV-2 naive subjects after two doses.
Changes in muscle stiffness have been reported with sarcopenia. Sonoelastography is an accessible and non-radiating imaging technique allowing quantification of elastic properties of tissue. We performed a systematic review of the literature to investigate whether sonoelastography can be a reliable method to assess sarcopenia in older patients. We searched Medline, Google Scholar, Scopus, SpringerLink and Science direct from January 1, 1990 to April 1, 2020. Three independent review authors assessed trial eligibility, extracted the data, and assessed risk of bias. We intended to learn which types of elastography have been tested, if such measures are repeatable, and if they have been compared to the currently accepted diagnostic method. Ten studies met the inclusion criteria. Most followed a cross-sectional design with young and older adult subgroups. The gastrocnemius, rectus femoris, and vastus intermedius appeared most frequently. Nine of the included studies used shear wave elastography and one-strain elastography. The passive elastic constant was significantly greater in sarcopenic versus healthy subjects after passive stretching (124.98 ± 60.82 vs. 46.35 ± 15.85, P = 0.004). However, even in non-sarcopenic patients, the age of the patient was responsible for about 45.5 % of the variance in SWV. Among ten included articles, four reported higher stiffness in the muscles of older adults, two reported lower stiffness, and four found no significant difference. Due to the substantial heterogenicity of actual data, we could not make any conclusions about the potential usefulness of elastography to assess sarcopenia. Further studies are needed, including a larger sample of older patients and using a standardized and reproducible protocol.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.