Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial.

BACKGROUND: Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications observed in patients with COVID-19. This study aimed to investigate the safety and efficacy of Auxora, a novel, intravenously administered CRAC channel inhibitor, in adults with severe or critical COVID-19 pneumonia. METHODS: A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess the safety and tolerability of Auxora. Following FDA guidance, study enrollment was halted early to allow for transition to a randomized, blinded, placebo-controlled study. RESULTS: In total, 17 patients with severe and three with critical COVID-19 pneumonia were randomized to Auxora and nine with severe and one with critical COVID-19 pneumonia to SOC. Similar proportions of patients receiving Auxora and SOC experienced ≥ 1 adverse event (75% versus 80%, respectively). Fewer patients receiving Auxora experienced serious adverse events versus SOC (30% versus 50%, respectively). Two patients (10%) receiving Auxora and two (20%) receiving SOC died during the 30 days after randomization. Among patients with severe COVID-19 pneumonia, the median time to recovery with Auxora was 5 days versus 12 days with SOC; the recovery rate ratio was 1.87 (95% CI, 0.72, 4.89). Invasive mechanical ventilation was needed in 18% of patients with severe COVID-19 pneumonia receiving Auxora versus 50% receiving SOC (absolute risk reduction = 32%; 95% CI, - 0.07, 0.71). Outcomes measured by an 8-point ordinal scale were significantly improved for patients receiving Auxora, especially for patients with a baseline PaO2/FiO2 = 101-200. CONCLUSIONS: Auxora demonstrated a favorable safety profile in patients with severe or critical COVID-19 pneumonia and improved outcomes in patients with severe COVID-19 pneumonia. These results, however, are limited by the open-label study design and small patient population resulting from the early cessation of enrollment in response to regulatory guidance. The impact of Auxora on respiratory complications in patients with severe COVID-19 pneumonia will be further assessed in a planned randomized, blinded, placebo-controlled study. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04345614 . Submitted on 7 April 2020.

Implementation of Routine Postpartum Depression Screening and Care Initiation Across a Multispecialty Health Care Organization: An 18-Month Retrospective Analysis.

Objectives Postpartum depression (PPD) affects approximately 10-20% of all mothers after giving birth. Adequate screening and follow-up care for the postpartum mother with depression is an essential component of quality care in this population. The purpose of this quality improvement project was to evaluate the quality and quantity of a postnatal PPD screening program and the subsequent initiation of needed PPD treatment in an integrated health system. Methods After implementing a standardized PPD screening process, we conducted an 18-month retrospective study of patient visits that required a PPD screen. Data were abstracted from medical records and analyzed to determine if postnatal PPD screening occurred, what quality of the screening was, and what follow-up measures were taken. Results Within the study timeframe, 28,389 postpartum and well-child visits were eligible for PPD screening. PPD screening occurred at 88% of eligible visits for approximately 5000 unique women. PPD was identified in 8.1% of screened women. Conclusions Of women with PPD, at least 44.8% were prescribed an SSRI and 21.4% attended a visit with a mental health professional, which is consistent with other studies. Screening can be successful through collaboration, although ongoing evaluation and process modification are necessary.