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Med (N Y) ; 3(4): 233-248.e6, 2022 04 08.
Article in English | MEDLINE | ID: covidwho-1882364


Background: Patients with severe coronavirus disease 2019 (COVID-19) develop a febrile pro-inflammatory cytokinemia with accelerated progression to acute respiratory distress syndrome (ARDS). Here we report the results of a phase 2, multicenter, randomized, double-blind, placebo-controlled trial of intravenous (IV) plasma-purified alpha-1 antitrypsin (AAT) for moderate to severe ARDS secondary to COVID-19 (EudraCT 2020-001391-15). Methods: Patients (n = 36) were randomized to receive weekly placebo, weekly AAT (Prolastin, Grifols, S.A.; 120 mg/kg), or AAT once followed by weekly placebo. The primary endpoint was the change in plasma interleukin (IL)-6 concentration at 1 week. In addition to assessing safety and tolerability, changes in plasma levels of IL-1ß, IL-8, IL-10, and soluble tumor necrosis factor receptor 1 (sTNFR1) and clinical outcomes were assessed as secondary endpoints. Findings: Treatment with IV AAT resulted in decreased inflammation and was safe and well tolerated. The study met its primary endpoint, with decreased circulating IL-6 concentrations at 1 week in the treatment group. This was in contrast to the placebo group, where IL-6 was increased. Similarly, plasma sTNFR1 was substantially decreased in the treatment group while remaining unchanged in patients receiving placebo. IV AAT did not definitively reduce levels of IL-1ß, IL-8, and IL-10. No difference in mortality or ventilator-free days was observed between groups, although a trend toward decreased time on ventilator was observed in AAT-treated patients. Conclusions: In patients with COVID-19 and moderate to severe ARDS, treatment with IV AAT was safe, feasible, and biochemically efficacious. The data support progression to a phase 3 trial and prompt further investigation of AAT as an anti-inflammatory therapeutic. Funding: ECSA-2020-009; Elaine Galwey Research Bursary.

COVID-19 , Respiratory Distress Syndrome , alpha 1-Antitrypsin Deficiency , COVID-19/complications , Humans , Interleukin-10/therapeutic use , Interleukin-6/therapeutic use , Interleukin-8/therapeutic use , Respiratory Distress Syndrome/drug therapy , alpha 1-Antitrypsin/therapeutic use , alpha 1-Antitrypsin Deficiency/drug therapy
Res Social Adm Pharm ; 18(7): 3204-3209, 2022 07.
Article in English | MEDLINE | ID: covidwho-1392547


The impact of the COVID-19 pandemic on pharmacy education worldwide has been immense, affecting students, educators and regulatory agencies. Pharmacy programmes have had to rapidly adapt in their delivery of education, maintaining standards while also ensuring the safety of all stakeholders. In this commentary, we describe the challenges, compromises and solutions adopted by our institution throughout the pandemic, the lessons learnt, adaptive measures taken, and strategies to develop and future-proof our curricula.

COVID-19 , Education, Pharmacy , Pharmacy , Students, Pharmacy , COVID-19/epidemiology , Curriculum , Humans , Pandemics
Ir J Psychol Med ; 37(3): 198-203, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-325201


Pharmacists, like psychiatrists, have modified their practices amidst COVID-19 in order to guarantee care and support to their patients. Designated an essential frontline service, community pharmacists are facing a spectrum of challenges to surmount to ensure patient care continues. These include assisting in the prevention of infection, managing supply chains, preventing stockpiling and provision of evidence-based medical information. However, disasters like COVID-19 disproportionately affect poor and vulnerable populations, and patients with mental health conditions may be among the hardest hit. Pharmacist-level, system-level and regulatory responses have sought to minimise this impact, although there is likely to be a lasting impression on the profession, both good and bad. This article reviews the pandemic-related challenges and responses by pharmacists, as well as forming recommendation for areas of professional support and role expansion, particularly in the case of mental health.

Betacoronavirus , Community Pharmacy Services , Coronavirus Infections/psychology , Mental Disorders/psychology , Pharmacists/psychology , Pneumonia, Viral/psychology , Professional Role/psychology , COVID-19 , Humans , Pandemics , Pharmacists/trends , SARS-CoV-2 , Surveys and Questionnaires