Articles: covid-19.
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Am. J. Respir. Crit. Care Med. · Aug 2023
Randomized Controlled Trial Multicenter StudyRepair of Acute Respiratory Distress Syndrome in COVID-19 by Stromal Cells (REALIST-COVID Trial): A Multicentre, Randomised, Controlled Trial.
Rationale: Mesenchymal stromal cells (MSCs) may modulate inflammation, promoting repair in coronavirus disease (COVID-19)-related acute respiratory distress syndrome (ARDS). Objectives: We investigated the safety and efficacy of ORBCEL-C (CD362 [cluster of differentiation 362]-enriched, umbilical cord-derived MSCs) in COVID-19-related ARDS. Methods: In this multicenter, randomized, double-blind, allocation-concealed, placebo-controlled trial (NCT03042143), patients with moderate to severe COVID-19-related ARDS were randomized to receive ORBCEL-C (400 million cells) or placebo (Plasma-Lyte 148). ⋯ There was no difference in the prevalence of interstitial lung disease at 1 year or significant medical events up to 2 years. ORBCEL-C modulated the peripheral blood transcriptome. Conclusion: ORBCEL-C MSCs were safe in subjects with moderate to severe COVID-19-related ARDS but did not improve surrogates of pulmonary organ dysfunction.
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Randomized Controlled Trial
Integrating Intimate Partner Violence Screening Programs in Primary Care: Results from a Hybrid-II Implementation-Effectiveness RCT.
The Veterans Health Administration initiated implementation facilitation to integrate intimate partner screening programs in primary care. This study investigates implementation facilitation's impact on implementation and clinical effectiveness outcomes. ⋯ Findings indicate that implementation facilitation may be a promising strategy for increasing the reach of IPV screening programs in primary care, thereby increasing IPV detection and strengthening connections to support services among the patient population.
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Randomized Controlled Trial
Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial.
Erythropoiesis-stimulating agents (ESAs) are the standard-of-care treatment for anaemia in most patients with lower-risk myelodysplastic syndromes but responses are limited and transient. Luspatercept promotes late-stage erythroid maturation and has shown durable clinical efficacy in patients with lower-risk myelodysplastic syndromes. In this study, we report the results of a prespecified interim analysis of luspatercept versus epoetin alfa for the treatment of anaemia due to lower-risk myelodysplastic syndromes in the phase 3 COMMANDS trial. ⋯ Celgene and Acceleron Pharma.
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Randomized Controlled Trial
Evaluation and Performance of a Positive Airway Pressure Device (CPAP-AirFlife™): A Randomized Crossover Non-Inferiority Clinical Study in Normal Subjects.
Background and Objectives: During the COVID-19, the demand for non-invasive ventilatory support equipment significantly increased. In response, a novel non-invasive ventilatory support model called CPAP-AirFlife™ was developed utilizing existing technologies. This model offers technological advantages, including an aerosol-controlled helmet suitable for high-risk environments such as ambulances. ⋯ Its technological advantages, including the aerosol-controlled helmet, make it suitable for high-risk environments. The device's accessibility and affordability make it a promising solution for implementation in low-level hospitals, particularly in rural areas. This study supports using CPAP-AirFlife™ as a practical option for non-invasive ventilatory support, providing a valuable contribution to respiratory care during the COVID-19 pandemic and beyond.