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Background: Calcium release-activated calcium (CRAC) channel inhibitors block proinflammatory cytokine release, preserve endothelial integrity and may effectively treat patients with severe COVID-19 pneumonia. Methods: CARDEA was a phase 2, randomized, double-blind, placebo-controlled trial evaluating the addition of Auxora, a CRAC channel inhibitor, to corticosteroids and standard of care in adults with severe COVID-19 pneumonia. The primary endpoint was time to recovery through Day 60, with secondary endpoints of all-cause mortality at Day 60 and Day 30. Due to declining rates of COVID-19 hospitalizations and encroachment of prohibited medications as standard of care, the trial was stopped early. Results: The pre-specified efficacy set consisted of the 261 patients with a baseline imputed PaO2/FiO2 £200 with 130 and 131 in the Auxora and placebo groups, respectively. Time to recovery was 7 vs. 10 days (P=0.0979) for patients who received Auxora vs. placebo, respectively. The all-cause mortality rate at Day 60 was 13.8% with Auxora vs. 20.6% with placebo (P=0.1449); Day 30 all-cause mortality was 7.7% and 17.6%, respectively (P=0.0165). Similar trends were noted in patients on high flow nasal cannula at baseline or those with a baseline imputed PaO2/FiO2 ≤100. Serious adverse events occurred less frequently in patients treated with Auxora vs. placebo. Conclusions: Auxora was safe and well tolerated with strong signals in both time to recovery and all-cause mortality through Day 60 in patients with severe COVID-19 pneumonia. Further studies of Auxora in combination with corticosteroids and other immunomodulatory agents are warranted.Trial registration: NCT04345614

Background: Extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation has been shown to improve the survival rate for patients with refractory VF/VT cardiac arrest. However, survival decreases as CPR duration increases and metabolic derangement progresses. We describe here a first of its kind multi-healthcare system consortium to rapid deploy ECMO-facilitated resuscitation to patients across a metropolitan area. Methods: This retrospective cohort study analyzed 58 consecutive patients prospectively enrolled in the Minnesota Mobile Resuscitation Consortium’s ECMO-facilitated resuscitation program. Inclusion criteria included: 1) age 18 to 75 years, 2) VF/VT as presenting rhythm, 3) refractory cardiac arrest despite 3 shocks, 4) body habitus accommodating a LUCAS mechanical CPR device, 5) estimated transfer time of < 30 min from a cannulating center. The consortium included multiple healthcare systems, dispatch services, and emergency medical services. Essential components included EMS, selection of 3 ECMO cannulation sites in geographically favorable emergency departments, a centralized ECMO center for post-arrest care, and a 24/7 mobile ECMO cannulation team. The cannulation team provided ECMO cannulation and medical care until the patient reached the ECMO center. Results: From December 1, 2019 to April 1, 2020, 58 consecutive patients were treated by the mobile ECMO team. Mean age was 57 ± 1.8 years. Of these, 25/58 (43%) were discharged from the hospital with neurologically favorable survival. Patients were cannulated at all three cannulation sites with transport to the nearest site leading to mean professional CPR time of 52 min. Conclusions: This represents the first community-wide ECMO-facilitated resuscitation program in the United States. A consortium including multiple healthcare systems and emergency medical services coordinated efforts to rapidly deliver patients with refractory VF/VT cardiac arrest to a highly trained and equipped mobile ECMO cannulation team resulting in improved neurologically favorable survival.

INTRODUCTION: During the upsurge of patient admissions o with COVID-19 pneumonia and ARDS requiring mechanical ventilation, both staffing and supply resources were severely limited Other institutions reported adapting their ventilator systems by removing the head/video display and placing it outside the room connected by an extension cable We felt this method had several drawbacks and undertook a rapid deployment of a more robust system which would allow complete in-room and remote ventilator monitoring and operation METHODS: At our urban tertiary care hospital, ventilator respiratory support is deployed in five geographically separated ICUs (medical, cardiovascular, surgical, neurocritical, burn) and a 55-bed emergency department with the Puritan Bennett 980 Ventilator (Medtronic, Minneapolis, MN) An adaptor module and interface computer were procured and installed on 40 deployed ventilators Communication was established by hospital secured Wi- Fi Medtronic OmniSense software provided the interface control Access could be established to any ventilator from any Microsoft Windows computer with secure access to the hospital network RESULTS: From initial concept to implementation was 10 days Approval and budgetary appropriation (approx US$1200 per ventilator) by hospital administration was rapid given the pressing nature of the COVID-19 pandemic Close collaboration with Medtronic facilitated the hardware modification and software installation Several benefits were found In-room visits by respiratory therapists and physicians were reduced by 4-5/day/pt , a reduction of about 50%, preventing the consumption of the corresponding amount of PPE resources and staff exposures The most significant benefits were seen during PEEP titrations, spontaneous breath trials, patient-ventilator dyssynchrony, and allowing collaboration between the intensivist/respiratory therapist on geographically distributed patients An unanticipated benefit was the time savings avoiding donning/doffing of PPE No complications or patient adverse events were experienced during or as a result of remote operation CONCLUSIONS: Implementation of remote ventilator operation is feasible and provides significant benefits, including facilitating communication, saving PPE resources, minimizing exposures, and maximizing staff efficiency

This study investigated the effects of using modified items in achievement tests to enhance accessibility. An experiment determined whether tests composed of modified items would reduce the performance gap between students eligible for an alternate assessment based on modified achievement standards (AA-MAS) and students not eligible, and the impact on student proficiency levels. Three groups of eighth-grade students ( N = 755) from four states took original and modified versions of reading and mathematics tests. Findings indicate modified item conditions were significantly easier for all students and modifications would result in more AA-MAS eligible students meeting proficiency status. Study limitations and follow-up research on item modifications and the performance of students with disabilities are discussed.

Motivated by the multiple-measures clause of recent federal policy regarding student eligibility for alternate assessments based on modified academic achievement standards (AA-MASs), this study examined how scores or combinations of scores from a diverse set of assessments predicted students’ end-of-year proficiency status on statewide achievement tests. Scores from 388 eighth-grade students, both with and without disabilities, from 3 states were compared for the predictive validity of test inferences from a set of brief online screening tests, teachers’ ratings of performance, and students’ previous year’s achievement tests. The research team developed screening tests in reading and mathematics that were found to be internally consistent and added predictive value to the identification of students who would perform at a level below proficient on state achievement tests of reading and mathematics. Although achievement results from the previous year were more predictive of future achievement results, scores from the online screening tests and from Performance Screening Guides could be used as supplements to typical achievement tests. Implications of these findings for educators in the 17 states currently using AA-MAS tests for students with disabilities are discussed, and needed future research is identified.

This study featured validity evidence for scores from states' alternate assessments of alternate academic achievement standards (AA-AASs). It evaluated students from 6 states who were eligible for an AA-AAS concurrently with measures of academic competence and adaptive behavior. The investigators also assessed students with disabilities who were not eligible for an AA-AAS by using the same measures, as well as by using general achievement tests. The main findings included that AA-AAS reading and math scores may reflect a unitary construct, that AA-AAS scores are highly related to adaptive behavior but also relate to academic competence and achievement, and that all these scores represent unique but overlapping constructs. These results have implications for AA-AAS developers and teachers working with students with significant cognitive disabilities.