Articles: covid-19.
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Randomized Controlled Trial
Oxygen therapy in patients with intermediate-risk acute pulmonary embolism: a randomized trial.
The effect of supplemental oxygen therapy in patients with intermediate-risk pulmonary embolism (PE) who do not have hypoxemia at baseline is uncertain. ⋯ In analyses limited by a small number of enrollees, compared with ambient air, supplemental oxygen did not significantly increase the proportion of patients with nonhypoxemic intermediate-risk PE whose RV to LV ratio normalized after 48 h of treatment. This pilot trial showed improvement in some ancillary efficacy outcomes and provides support for a definitive clinical outcomes trial.
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Randomized Controlled Trial Pragmatic Clinical Trial
"How" Versus "Why" Messaging to Increase Uptake of Booster Vaccination Against COVID-19: Results of a Pragmatic Randomized Trial.
Messages aimed at increasing uptake of vaccines have been modestly successful, perhaps in part because they often focus on why individuals should receive a vaccine. Construal Level Theory posits that messages emphasizing "how" to get a vaccine may be more effective at encouraging vaccination than emphasizing "why." This message framing may be particularly important for COVID-19 booster acceptance. ⋯ This trial is registered at clinicaltrials.gov, ID: NCT04871776 . Initial release occurred 04/30/2021.
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Randomized Controlled Trial
Imatinib treatment improves hyperglycaemic dysregulation in severe COVID-19: a secondary analysis of blood biomarkers in a randomised controlled trial.
SARS-CoV-2 can induce insulin resistance, which is, among others, mediated by adipose tissue dysfunction and reduced angiotensin-converting enzyme 2 (ACE2) enzymatic activity. In SARS-CoV-2-infected mice, the tyrosine kinase inhibitor imatinib attenuates inflammation and improves insulin sensitivity. Here, we report the effects of imatinib on incident hyperglycaemia, circulating levels of glucoregulatory proteins, longitudinal insulin sensitivity and ACE-2 enzymatic activity in 385 hospitalized COVID-19 patients who participated in a randomized, double-blind, placebo-controlled clinical trial. ⋯ The incidence of severe hyperglycaemia was significantly lower in patients treated with imatinib, while insulin production and central insulin sensitivity were unaffected. Imatinib increased plasma angiotensin-2 and adiponectin levels, and decreased c-Jun N-terminal protein kinase 1 (JNK1), JNK2 and interleukin-6 levels. These findings suggest that imatinib restores endocrine control of peripheral glucose uptake in COVID-19.
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Randomized Controlled Trial
Novel subtypes of severe COVID-19 respiratory failure based on biological heterogeneity: a secondary analysis of a randomized controlled trial.
Despite evidence associating inflammatory biomarkers with worse outcomes in hospitalized adults with COVID-19, trials of immunomodulatory therapies have met with mixed results, likely due in part to biological heterogeneity of participants. Latent class analysis (LCA) of clinical and protein biomarker data has identified two subtypes of non-COVID acute respiratory distress syndrome (ARDS) with different clinical outcomes and treatment responses. We studied biological heterogeneity and clinical outcomes in a multi-institutional platform randomized controlled trial of adults with severe COVID-19 hypoxemic respiratory failure (I-SPY COVID). ⋯ We discovered evidence of two novel biological subtypes of severe COVID-19 with significantly different clinical outcomes. These subtypes differed from previously established hyper- and hypo-inflammatory non-COVID subtypes of ARDS. Biological heterogeneity may explain inconsistent findings from trials of hospitalized patients with COVID-19 and guide treatment approaches.
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Journal of critical care · Feb 2024
Randomized Controlled Trial Multicenter StudyThe safety and efficacy of stem cells for the treatment of severe community-acquired bacterial pneumonia: A randomized clinical trial.
Evaluate the safety profile of expanded allogeneic adipose-derived mesenchymal stem cell (eASC) for the treatment of severe community-acquired bacterial pneumonia (CABP). ⋯ Cx611 was well tolerated in severe CABP. These data provide insights for future stem cell clinical study designs, endpoints and sample size calculation.