Background. Interventions mitigating progression to mechanical ventilation in COVID-19 would markedly improve outcome and reduce healthcare utilization. We hypothesized that immunomodulation with IVIG would improve oxygenation and reduce length of hospital stay and progression to mechanical ventilation in COVID-19 pneumonia. Methods. Patients with COVID-19 were randomized 1:1 to prospectively receive standard of care (SOC) plus intravenous immunoglobulin (IVIG) 0.5 g/kg/day x 3 days with methylprednisolone 40 mg 30 minutes before infusion versus SOC alone. Results. 16 subjects received IVIG plus SOC and 17 SOC alone. The median age was 51 years for SOC and 58 years for IVIG. APACHE II scores and Charlson comorbidity indices were similar for IVIG and SOC (median 7.5 vs 7 and 2 for both, respectively). Seven SOC versus 2 IVIG subjects required mechanical ventilation (p=0.12, Fisher exact test). Among subjects with A-a gradient of >200 mm Hg at enrollment, the IVIG group showed i) a lower rate of progression to requiring mechanical ventilation (2/14 vs 7/12, p=0.038 Fisher exact test), ii) shorter median hospital length of stay (11 vs 19 days, p=0.01 Mann Whitney U), iii) shorter median ICU stay (2.5 vs 12.5 days, p=0.006 Mann Whitey U), and iv) greater improvement in PaO2/FiO2 at 7 days (median [range] change from time of enrollment +131 [+35 to +330] vs +44.5 [-115 to +157], p=0.01, Mann Whitney-U test) than SOC. Conclusion. This pilot prospective randomized study comprising largely of Latino patients showed that IVIG significantly improved hypoxia and reduced hospital length of stay and progression to mechanical ventilation in COVID-19 patients with A-a gradient >200 mm Hg.

Objectives: Dysregulated neutrophil and platelet interactions mediate immunothrombosis and cause lung injury in coronavirus disease 2019. IV immunoglobulin modulates neutrophil activation through FcγRIII binding. We hypothesized that early therapy with IV immunoglobulin would abrogate immunothrombosis and improve oxygenation and reduce progression to mechanical ventilation in coronavirus disease 2019 pneumonia. Design: Prospective randomized open label. Setting: Inpatient hospital. Patients and Intervention: Hypoxic subjects with coronavirus disease 2019 pneumonia were randomized 1:1 to receive standard of care plus IV immunoglobulin 0.5 g/kg/d with methylprednisolone 40 mg 30 minutes before infusion for 3 days versus standard of care alone. Main Results: Sixteen subjects received IV immunoglobulin and 17 standard of care. Median ages were 51 and 58 years for standard of care and IV immunoglobulin, respectively. Acute Physiology and Chronic Health Evaluation II and Charlson comorbidity scores were similar for IV immunoglobulin and standard of care. Seven standard of care versus two IV immunoglobulin subjects required mechanical ventilation (p = 0.12, Fisher exact test). Among subjects with A-a gradient of greater than 200 mm Hg at enrollment, the IV immunoglobulin group showed: 1) a lower rate of progression to requiring mechanical ventilation (2/14 vs 7/12, p = 0.038 Fisher exact test), 2) shorter median hospital length of stay (11 vs 19 d, p = 0.01 Mann Whitney U test), 3) shorter median ICU stay (2.5 vs 12.5 d, p = 0.006 Mann Whitey U test), and 4) greater improvement in Pao 2/Fio 2 at 7 days (median [range] change from time of enrollment +131 [+35 to +330] vs +44·5 [–115 to +157], p = 0.01, Mann Whitney U test) than standard of care. Pao 2/Fio 2 improvement at day 7 was significantly less for the standard of care patients who received glucocorticoid therapy than those in the IV immunoglobulin arm (p = 0.0057, Mann Whiney U test). Conclusions: This pilot study showed that IV immunoglobulin significantly improved hypoxia and reduced hospital length of stay and progression to mechanical ventilation in coronavirus disease 2019 patients with A-a gradient greater than 200 mm Hg. A phase 3 multicenter randomized double-blinded clinical trial is under way to validate these findings.

Introduction Despite considerable scientific debate, there have been no prospective clinical studies on the effects of angiotensin II receptor blockers (ARBs) on the course of COVID-19 infection. Losartan is the ARB that was chosen to be tested in this study. Methods Patients with COVID-19 and mild hypoxia (receipt of ≤ 3 L/min O 2 by nasal cannula) admitted to three hospitals were randomized in a 1:1 ratio within 72 h of SARS-CoV-2 nucleic acid testing confirmation to prospectively receive standard of care (SOC) alone or SOC plus losartan 12.5 mg orally every 12 h for 10 days or until hospital discharge, with the option to titrate upward dependent on blood pressure tolerability. Primary composite endpoint was receipt of mechanical ventilation or death before receiving ventilation. Subjects were followed until discharge to home or until an endpoint was met in the hospital. Results Sixteen subjects received an ARB plus SOC and 15 subjects received SOC alone. The median age was 53 years for both groups. Median time from hospital admission to study enrollment was 2 days (range 1–6) for the ARB group and 2 days (range 1–4) for the SOC group. Mean Charlson comorbidity index was 2 for both groups. One subject in each group achieved the composite endpoint. Conclusion This small prospective randomized open-label study showed no clinically significant impacts of ARB therapy in mildly hypoxemic patients hospitalized with COVID-19 early in the pandemic. A larger prospective randomized placebo-controlled trial would be needed to confirm these findings or capture less pronounced effects and probably should focus on outpatients earlier in disease course. Trial Registration clinicaltrials.gov; March 27, 2020; NCT04340557.

Improving the ability to predict which patients are at increased risk for readmission can lead to more effective interventions and greater compliance with CMS Hospital Readmissions Reduction Program (HRRP) requirements. This study evaluated the performance of a risk model that used data from a health system's electronic medical record (EMR) to predict all-cause readmission among adult inpatients with acute medical conditions, with a specific focus on the impact of including behavioral health screening data. The study included 39,155 unique adult patients admitted during 2015 to 4 acute care inpatient facilities within a nonprofit community-based health care system. The risk model integrated a comprehensive set of data elements including demographics, psychosocial characteristics, medical history, assessment results, and clinical events. Predictive models were constructed using a multivariable logistic regression with a stepwise selection approach. Among study participants, the mean age was 62.9 years, 48.0% were male, 31.2% had comorbid psychiatric conditions, and 6986 had medical conditions/procedures subject to HRRP penalties. Results from exploratory predictive analyses demonstrated that any patients with a Serious Mental Illness (SMI) diagnosis were 28% more likely to be readmitted within 30 days, and the likelihood of readmission associated with SMI increased to 56% for patients with medical conditions subject to HRRP penalties. As health care systems face increasing pressures to reduce readmissions and avoid CMS HRRP financial penalties, study results indicate the importance of including behavioral health data from EMRs and screening assessments for all inpatients to improve discharge planning and patient outcomes.

This article presents findings from a study designed to evaluate the clinical outcomes of EAP interventions. Participants received EAP services from ValueOptions' Kentucky office and completed the Behavior and Symptom Identification Scale (BASIS-32 ® ) upon intake and follow-up approximately one month later. Analyses included stratification by severity of difficulty at intake and demographic variables, as well as specific results for mandatory referrals and substance abuse as a presenting problem. In general, significant positive findings were demonstrated, suggesting that EAP services can have a meaningful impact on the reduction of symptoms and improvement in functioning.