Background Coronavirus disease 2019 (COVID-19) continues to stress the healthcare system. Neutralizing monoclonal antibodies (MABs) were effective in reducing COVID-19 related hospitalizations and emergency department (ED) visits in their respective clinical trials. However, these results have yet to be reproduced in a practical setting following implementation of current FDA guidance. Methods This retrospective cohort study included outpatients with confirmed COVID-19 infection, had mild/moderate symptoms for 10 days or less, and deemed high-risk for severe COVID-19 under FDA’s Emergency Use Authorization (EUA) for MABs. Patients who received either bamlanivimab or casirivimab/imdevimab from 11/18/2020 through 01/05/2021 were included (n=200). This was compared against a control cohort of randomly selected high-risk COVID-19 outpatients who declined or were not referred for MAB during the same period (n=200). The primary outcome was a composite of 29-day COVID-19 related hospitalizations and/or ED visits. Prespecified secondary outcomes included the individual components of the primary endpoint, 29-day all-cause mortality, and serious adverse drug events. Results Patients treated with MAB were significantly less likely to be hospitalized or visit the ED compared with patients not treated with MAB (13.5% vs. 40.5%; OR=0.23; 95% CI 0.14 to 0.38; p<0.001). The mortality rate was 0% in the MAB group compared with 3.5% in the control group (p=0.02). Only 2 patients receiving MAB experienced a serious adverse event requiring treatment. Conclusions Among high-risk COVID-19 outpatients with mild/moderate symptoms, early administration of MABs can potentially reduce the strain on the healthcare system during the current pandemic.
Objective: To determine internal medicine (IM) residents’ knowledge of, attitudes towards, and barriers to prescribing buprenorphine for opioid use disorder (OUD). Methods: We conducted a cross-sectional study of IM residents across all 35 Accreditation Council for Graduate Medical Education (ACGME) accredited Florida IM residency programs. We used an online survey to collect information about resident demographics, substance use curriculums, career interests, content knowledge about diagnosing and managing OUD, and attitudes about and barriers to prescribing buprenorphine for OUD. We used Chi-square test to explore differences in interest in prescribing buprenorphine. We created a composite knowledge score and investigated distribution of knowledge among characteristics via Mann-Whitney U test. Results: There were 161 participants (response rate 16.0%, n = 1008) across 35 programs Seventy-seven percent of residents provided care for patients with OUD more than once per month. Seventy-four percent report no buprenorphine prescribing training. Higher knowledge scores, interest in primary care, being an intern, and caring for patients with OUD more than monthly were associated with interest in obtaining a buprenorphine waiver (P < 0.05). Limited knowledge about OUD was the most important barrier to prescribing buprenorphine. Eighty-nine percent support legislation to deregulate buprenorphine. Conclusions: Knowledge about managing OUD was poor and represented the most commonly cited barrier to prescribing buprenorphine. Residents want to expand their role in treating OUD. Our findings warrant incorporating addiction medicine into residency curriculum standards. Legislation removing the buprenorphine waiver requirement may increase the number of resident buprenorphine prescribers and improve treatment options for patients with opioid addiction.
IMPORTANCEThe monoclonal antibody combination of casirivimab and imdevimab reduced viral load, hospitalization, or death when administered as a 1200-mg or greater intravenous (IV) dose in a phase 3 COVID-19 outpatient study. Subcutaneous (SC) and/or lower IV doses should increase accessibility and/or drug supplies for patients. OBJECTIVE To assess the virologic efficacy of casirivimab and imdevimab across different IV and SC doses compared with placebo. DESIGN, SETTING, AND PARTICIPANTS This phase 2, randomized, double-blind, placebocontrolled, parallel-group, dose-ranging study included outpatients with SARS-CoV-2 infection at 47 sites across the United States. Participants could be symptomatic or asymptomatic; symptomatic patients with risk factors for severe COVID-19 were excluded. Data were collected from December 15, 2020, to March 4, 2021. INTERVENTIONS Patients were randomized to a single IV dose (523 patients) of casirivimab and imdevimab at 300, 600, 1200, or 2400 mg or placebo; or a single SC dose (292 patients) of casirivimab and imdevimab at 600 or 1200 mg or placebo. MAIN OUTCOMES AND MEASURES The primary end point was the time-weighted average daily change from baseline (TWACB) in viral load from day 1 (baseline) through day 7 in patients seronegative for SARS-CoV-2 at baseline. RESULTS Among 815 randomized participants, 507 (282 randomized to IV treatment, 148 randomized to SC treatment, and 77 randomized to placebo) were seronegative at baseline and included in the primary efficacy analysis. Participants randomized to IV had a mean (SD) age of 34.6 (9.6) years (160 [44.6%] men; 14 [3.9%] Black; 121 [33.7%] Hispanic or Latino; 309 [86.1%] White); those randomized to SC had a mean age of 34.1 (10.0) years (102 [45.3%] men; 75 [34.7%] Hispanicor Latino; 6 [2.7%] Black; 190 [84.4%] White). All casirivimab and imdevimab treatments showed significant virologic reduction through day 7. Least-squares mean differences in TWACB viral load for casirivimab and imdevimab vs placebo ranged from -0.56 (95% CI; -0.89 to -0.24) log 10 copies/mL for the 1200-mg IV dose to -0.71 (95% CI, -1.05 to -0.38) log 10 copies/mL for the 2400-mg IV dose. There were no adverse safety signals or dose-related safety findings, grade 2 or greater infusionrelated or hypersensitivity reactions, grade 3 or greater injection-site reactions, or fatalities. Two serious adverse events not related to COVID-19 or the study drug were reported.
BACKGROUND The prevalence of both atrial fibrillation (AF) and stroke is increasing. Stroke is common in AF and can have devastating consequences, especially when AF is unrecognized and anticoagulation is not initiated.OBJECTIVE The purpose of this study was to demonstrate the feasibility and yield, both in identifying previously undiagnosed AF and in educating patients and caregivers about AF, of systematic screening events in internal medicine practices using a mobile electrocardiogram device (Kardia/AliveCor iECG).METHODS With support from the Heart Rhythm Society and the American College of Physicians, 5 internal medicine practices performed systematic screening and education of patients at higher risk of AF using the Kardia/AliveCor device and a variety of educational materials. Patients screened as "unclassified" or "possible AF" were referred for further evaluation. Patients and providers (physicians, nurses, and allied professionals) assessed the screening process.
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