ABSTRACT
BACKGROUND: Coronavirus disease 2019 (COVID-19) requiring hospitalization is characterized by robust antibody production, dysregulated immune response, and immunothrombosis. Fostamatinib is a novel spleen tyrosine kinase inhibitor that we hypothesize will ameliorate Fc activation and attenuate harmful effects of the anti-COVID-19 immune response. METHODS: We conducted a double-blind, randomized, placebo-controlled trial in hospitalized adults requiring oxygen with COVID-19 where patients receiving standard of care were randomized to receive fostamatinib or placebo. The primary outcome was serious adverse events by day 29. RESULTS: A total of 59 patients underwent randomization (30 to fostamatinib and 29 to placebo). Serious adverse events occurred in 10.5% of patients in the fostamatinib group compared with 22% in placebo (Pâ =â .2). Three deaths occurred by day 29, all receiving placebo. The mean change in ordinal score at day 15 was greater in the fostamatinib group (-3.6â ±â 0.3 vs -2.6â ±â 0.4, Pâ =â .035) and the median length in the intensive care unit was 3 days in the fostamatinib group vs 7 days in placebo (Pâ =â .07). Differences in clinical improvement were most evident in patients with severe or critical disease (median days on oxygen, 10 vs 28, Pâ =â .027). There were trends toward more rapid reductions in C-reactive protein, D-dimer, fibrinogen, and ferritin levels in the fostamatinib group. CONCLUSION: For COVID-19 requiring hospitalization, the addition of fostamatinib to standard of care was safe and patients were observed to have improved clinical outcomes compared with placebo. These results warrant further validation in larger confirmatory trials. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov, NCT04579393.
Subject(s)
COVID-19 Drug Treatment , Adult , Aminopyridines , Double-Blind Method , Hospitalization , Humans , Morpholines , Oxazines/therapeutic use , Oxygen , Pyridines/therapeutic use , Pyrimidines , SARS-CoV-2 , Treatment OutcomeABSTRACT
BACKGROUND: Advance care planning (ACP) that generates an advanced directive (AD) can ensure patient autonomy at end of life. ACP is challenging for healthcare providers. Delaying patient ACP may lead to poor quality end-of-life care. Facilitation of early ACP by bedside RNs and social workers (SWs) may improve end-of-life care. OBJECTIVE: To determine whether improved ACP by RNs and SWs impacts care transition times for patients with advanced cancers. METHODS: A pre-/post-educational intervention designed to reinforce the roles of RNs and SWs in facilitating early ACP and timely documentation of an AD on an inpatient oncology unit. RESULTS: AD documentation increased by 12% between pre- and post-intervention period. There was a nonsignificant trend toward longer lengths of stay for patients transitioning care without an AD compared to those patients with and AD. DISCUSSION: Bedside RNs and SWs are in a key position to facilitate early ACP which can positively impact care quality at end of life. However, ACP is a collaborative team effort, best initiated early by the primary oncology providers. CONCLUSION: Early ACP may improve quality end-of-life care. IMPLICATIONS FOR NURSING: Continuing education for RNs and SWs to enhance coordination with primary oncology teams to facilitate earlier ACP is recommended.
