Articles: covid-19.
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Randomized Controlled Trial
Different dose regimens of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373) in younger and older adults: A phase 2 randomized placebo-controlled trial.
NVX-CoV2373 is a recombinant severe acute respiratory coronavirus 2 (rSARS-CoV-2) nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins and Matrix-M1 adjuvant. ⋯ The study confirmed the phase 1 findings that the 2-dose regimen of 5-μg NVX-CoV2373 is highly immunogenic and well tolerated in younger adults. In addition, in older adults, the 2-dose regimen of 5 μg was also well tolerated and showed sufficient immunogenicity to support its use in late-phase efficacy studies.
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Randomized Controlled Trial
Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial.
Given the scale of the ongoing COVID-19 pandemic, the development of vaccines based on different platforms is essential, particularly in light of emerging viral variants, the absence of information on vaccine-induced immune durability, and potential paediatric use. We aimed to assess the safety and immunogenicity of an MF59-adjuvanted subunit vaccine for COVID-19 based on recombinant SARS-CoV-2 spike glycoprotein stabilised in a pre-fusion conformation by a novel molecular clamp (spike glycoprotein-clamp [sclamp]). ⋯ Coalition for Epidemic Preparedness Innovations, National Health and Medical Research Council, Queensland Government, and further philanthropic sources listed in the acknowledgments.
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Randomized Controlled Trial
Same-day SARS-CoV-2 antigen test screening in an indoor mass-gathering live music event: a randomised controlled trial.
The banning of mass-gathering indoor events to prevent SARS-CoV-2 spread has had an important effect on local economies. Despite growing evidence on the suitability of antigen-detecting rapid diagnostic tests (Ag-RDT) for mass screening at the event entry, this strategy has not been assessed under controlled conditions. We aimed to assess the effectiveness of a prevention strategy during a live indoor concert. ⋯ For the Spanish translation of the abstract see Supplementary Materials section.
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Minerva anestesiologica · Oct 2021
Randomized Controlled TrialWhat's new on EEG monitoring in the ICU.
Continuous video-EEG (cEEG, lasting hours to several days) is increasingly used in ICU patients, as it is more sensitive than routine video-EEG (rEEG, lasting 20-30 min) to detect seizures or status epilepticus, and allows more frequent changes in therapeutic regimens. However, cEEG is more resource-consuming, and its relationship to outcome compared to repeated rEEG has only been formally assessed very recently in a randomized controlled trial, which did not show any significant difference in terms of long-term mortality or functional outcome. ⋯ Prolonged EEG has been used recently in patients with severe COVID-19 infection, the proportion of seizures seems albeit relatively low, and similar to ICU patients with medical conditions. As a timely EEG recording is recommended in the ICU in any case, recent technical developments may ease its use in clinical practice.
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Randomized Controlled Trial
Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial.
Older adults, including those with long-term conditions (LTCs), are vulnerable to social isolation. They are likely to have become more socially isolated during the Coronavirus Disease 2019 (COVID-19) pandemic, often due to advice to "shield" to protect them from infection. This places them at particular risk of depression and loneliness. There is a need for brief scalable psychosocial interventions to mitigate the psychological impacts of social isolation. Behavioural activation (BA) is a credible candidate intervention, but a trial is needed. ⋯ In this study, we observed that BA is a credible intervention to mitigate the psychological impacts of COVID-19 isolation for older adults. We demonstrated that it is feasible to undertake a trial of BA. The intervention can be delivered remotely and at scale, but should be reserved for older adults with evidence of depressive symptoms. The significant reduction in loneliness is unlikely to be a chance finding, and replication will be explored in a fully powered randomised controlled trial (RCT).