Background: There are many pharmacologic therapies that are being used or considered for treatment of COVID-19. There is a need for frequently updated practice guidelines on their use, based on critical evaluation of rapidly emerging literature. Objective: Develop evidence-based rapid guidelines intended to support patients, clinicians and other health-care professionals in their decisions about treatment and management of patients with COVID-19. Methods: IDSA formed a multidisciplinary guideline panel of infectious disease clinicians, pharmacists, and methodologists with varied areas of expertise. Process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then a systematic review of the peer-reviewed and grey literature was conducted. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations. Results: The IDSA guideline panel agreed on 7 treatment recommendations and provided narrative summaries of other treatments undergoing evaluations. Conclusions:The panel expressed the overarching goal that patients be recruited into ongoing trials, which would provide much needed evidence on the efficacy and safety of various therapies for COVID-19, given that we could not make a determination whether the benefits outweigh harms for most treatments.

Background There are many pharmacologic therapies that are being used or considered for treatment of coronavirus disease 2019 (COVID-19), with rapidly changing efficacy and safety evidence from trials. Objective Develop evidence-based, rapid, living guidelines intended to support patients, clinicians, and other healthcare professionals in their decisions about treatment and management of patients with COVID-19. Methods In March 2020, the Infectious Diseases Society of America (IDSA) formed a multidisciplinary guideline panel of infectious disease clinicians, pharmacists, and methodologists with varied areas of expertise to regularly review the evidence and make recommendations about the treatment and management of persons with COVID-19. The process used a living guideline approach and followed a rapid recommendation development checklist. The panel prioritized questions and outcomes. A systematic review of the peer-reviewed and grey literature was conducted at regular intervals. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations. Results Based on the most recent search conducted on May 31, 2022, the IDSA guideline panel has made 30 recommendations for the treatment and management of the following groups/populations: pre- and post-exposure prophylaxis, ambulatory with mild-to-moderate disease, hospitalized with mild-to-moderate, severe but not critical, and critical disease. As these are living guidelines, the most recent recommendations can be found online at: https://idsociety.org/COVID19guidelines. Conclusions At the inception of its work, the panel has expressed the overarching goal that patients be recruited into ongoing trials. Since then, many trials were done which provided much needed evidence for COVID-19 therapies. There still remain many unanswered questions as the pandemic evolved which we hope future trials can answer.

Despite the challenges of the pandemic, there has been substantial progress with COVID-19 therapies. Pivotal COVID-19 trials like SOLIDARITY, RECOVERY and ACCT-1 were rapidly conducted and data disseminated to support effective therapies.. However, critical shortcomings remain on trial conduct, dissemination and interpretation of study results, and regulatory guidance in pandemic settings. The lessons we learned have implications for both the current pandemic and future emerging infectious diseases. There is a need for establishing and standardizing clinical meaningful outcomes in therapeutic trials and for targeting defined populations and phenotypes that will most benefit from specific therapies. Standardized processes should be established for rapid and critical data review and dissemination to ensure scientific integrity. Clarity around the evidence standards needed for issuance of both Emergency Use Authorization (EUA) and Biologic License Application (BLA) should be established and an infrastructure for executing rapid trials in epidemic settings maintained.

Given the urgent need for treatments during the COVID-19 pandemic, the US Food and Drug Administration (FDA) issued emergency use authorizations (EUAs) for multiple therapies. In several instances, however, these EUAs were issued before sufficient evidence of a given therapy’s efficacy and safety were available, potentially promoting ineffective or even harmful therapies and undermining the generation of definitive evidence. We describe the strengths and weaknesses of the different therapeutic EUAs issued during this pandemic. We also contrast them to the vaccine EUAs and suggest a framework and criteria for an evidence-based, trustworthy, and publicly transparent therapeutic EUA process for future pandemics.

Effective team-based models of care, such as the Patient-Centered Medical Home, require electronic tools to support proactive population management strategies that emphasize care coordination and quality improvement. Despite the spread of electronic health records (EHRs) and vendors marketing population health tools, clinical practices still may lack the ability to have: (1) local control over types of data collected/reports generated, (2) timely data (eg, up-to-date data, not several months old), and accordingly (3) the ability to efficiently monitor and improve patient outcomes. This article describes a quality improvement project at the hospital system level to develop and implement a flexible panel management (PM) tool to improve care of subpopulations of patients (eg, panels of patients with diabetes) by clinical teams. An in-depth case analysis approach is used to explore barriers and facilitators in building a PM registry tool for team-based management needs using standard data elements (eg, laboratory values, pharmacy records) found in EHRs. Also described are factors that may contribute to sustainability; to date the tool has been adapted to 6 disease-focused subpopulations encompassing more than 200,000 patients. Two key lessons emerged from this initiative: (1) though challenging, team-based clinical end users and information technology needed to work together consistently to refine the product, and (2) locally developed population management tools can provide efficient data tracking for frontline clinical teams and leadership. The preliminary work identified critical gaps that were successfully addressed by building local PM registry tools from EHR-derived data and offers lessons learned for others engaged in similar work. (Population Health Management 2016;19:232-239).

Background We assessed correlation between prior acceptance of COVID-19 vaccination and acceptance of monoclonal antibody (MAb) treatment for mild-to-moderate COVID-19. Methods Adult outpatients evaluated for treatment with MAb between August 31st, 2021 and April 23, 2022 in a large tertiary care VA healthcare system were included. MAb therapies administered over the period included casirivimab-imdevimab, sotrovimab, and bebtelovimab. All patients were screened by a small central clinician team with experience discussing COVID therapies under Emergency Use Authorization (EUA). Baseline characteristics, rationale for not offering MAb, and rates of vaccination and acceptance of therapy were recorded. In addition, rates of acceptance for the initial 4 months were compared to rates during the second 4 months of the program, using Chi-square or Fisher’s exact test. Results 203 patients (mean age 68, 91% male) with early COVID-19 were screened for MAb. 68% were vaccinated. 158 (78%) of those screened were offered MAb. The most common reason MAb was not offered was duration of illness longer than specified by EUA (65%). 112 (71%) patients offered MAb accepted, and 94 (84%) received MAb. Of 106 vaccinated patients offered MAb, 81 (76%) accepted. In contrast, of 52 unvaccinated patients offered MAb, only 31 (60%) accepted (Chi-square p = 0.046). However, when analyzed over time, unvaccinated patients were significantly more likely to accept MAb during the second 4 months of the program (7/7 patients, 100%) than during the first 4 months of the program (24/45 patients, 53%, Fisher’s exact p = 0.033). This disparity was not seen in vaccinated patients, who accepted MAb at a rate of 73% during the first half of the program, and 88% during the second half (Chi-square p = 0.19). Conclusion Vaccinated patients were significantly more likely to accept MAb therapy for COVID-19 than unvaccinated patients, suggesting that willingness to accept COVID-19 vaccination predicts willingness to accept other COVID-19 therapeutics. However, disparity in acceptance rates in our population is significantly attenuating over time, suggesting a “late-adopter,” phenomenon that has implications for continued efforts to encourage therapeutics and vaccines for COVID-19. Disclosures All Authors: No reported disclosures.

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Background Ten percent of adult, outpatient visits result in an antibiotic prescription (Rx). At the start of our intervention, our VA healthcare system consisted of 13 community-based outpatient clinics (CBOCs), 9 of which did not have an onsite pharmacy but utilized automated dispensing cabinets (ADCs) for prepackaged outpatient Rxs. ADC antibiotic orders are generated from electronic medical record (EMR) order sets. The stewardship team shortened the durations of 5 antibiotics in the ADC order sets to make them consistent with current literature and guidelines. We assessed the impact of these changes on antibiotic prescribing habits. Methods We compared outpatient antibiotic Rx data between 10/1/2018-9/30/2019 (pre-intervention) and 10/1/19-9/30/20 (post-intervention) from 8 CBOCs with ADCs (1 closed during the pandemic). Amoxicillin-clavulanate 875/125mg (AMC), cephalexin 500mg (CPH), levofloxacin 500mg and 750mg (LEV 500 and LEV 750), and sulfamethoxazole-trimethoprim 800/160mg (SXT) prescription durations were all reduced by 3 days. Process metrics included days supplied/1000 prescriptions (DS/1000 Rx), median DS, and ADC utilization rates. We used Mann-Whitney U and correlation statistical analyses to assess differences and associations. Results The DS/1000 Rx of antibiotics with a default duration change decreased in the post-intervention phase for CBOCs with ADCs (AMC, -25.4%; CPH, -21.1%; LEV 500, -18.9%; LEV 750, -28.0%; SXT, -27.4%). The median DS for these antibiotics all reduced by 3 days in concordance with new ADC prescriptions defaults (AMC, 10 vs 7 days, P< 0.001; CPH, 10 vs 7 days, P< 0.001; LEV 500, 8 vs 5 days, P< 0.001; LEV 750, 8 vs 5 days, P< 0.001; SXT 10 vs 7 days, P< 0.001). Due to COVID-19, 7/8 ADC CBOCs closed for in-person visits from 3/20/20-5/4/20. ADC utilization was inversely proportional to DS/1000 Rx for most antibiotics (R: -0.51 to -0.77) except SXT. Conclusion EMR-driven reductions in ADC default Rx durations led to a corresponding decrease in overall outpatient antibiotic prescribing. Higher DS/1000 Rx were often associated with lower ADC utilization. Informatics-driven antibiotic interventions may be potential outpatient stewardship tools to increase guideline-concordant prescribing across multisite healthcare systems. Disclosures Sharanie Sims, PharmD, AbbVie (formerly Allergan) (Speaker’s Bureau)