1 Coronavirus Disease (COVID-19) Treatment - Adult - Inpatient/Ambulatory/Emergency Department External Clinical Practice Guideline Endorsement Note: Active Table of Contents – Click each header below to jump to the section of interest Table of Contents INTRODUCTION .................................................................................................................................4 SCOPE ................................................................................................................................................4 APPENDIX A. RELATIVE OR ABSOLUTE CONTRAINDICATIONS TO THERAPEUTIC ANTICOAGULATION IN HOSPITALIZED PATIENTS WITH COVID-19 ...........................................................................................6 REFERENCES ......................................................................................................................................7 Copyright © 2022 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission. Contact: CCKM@uwhealth.org Last Revised: 10/2022 Effective 10/20/2022. Contact CCKM@uwhealth.org for previous versions 2 Content Expert(s): Name: E. Ann Misch, MD – Infectious Disease (CONSIDER Workgroup) Phone Number: (608) 263-1545 Email Address: eamisch@medicine.wisc.edu Eliot Williams, MD – Hematology (Coagulopathy Workgroup) Phone Number: (608) 262-5327 Email Address: williams@medicine.wisc.edu Contact for Changes: Lucas Schulz, PharmD - Pharmacy Phone Number: (608) 890-8617 Email Address: lschulz2@uwhealth.org Guideline Author(s): Lucas Schulz, PharmD - Pharmacy Erin Robinson, PharmD – Drug Policy Program COVID-19 Antiviral and Host Immunomodulatory (CONSIDER) Workgroup Members: • Prakash Balasubramanian, MD - Infectious Diseases • Meghan Brennan, MD - Infectious Diseases • Brian Buss, PharmD – Pharmacy • Douglas Coursin, MD - Critical Care • Jeff Fish, PharmD - Pharmacy • Shivani Garg, MD - Rheumatology • Brian Griffith, MD - Critical Care • Eric Johannsen, MD - Infectious Diseases • Susan Johnston, PharmD - Pharmacy • Mark Juckett, MD - Hematology/Oncology • Alex Lepak, MD - Infectious Diseases • Micah Long, MD - Critical Care • E. Ann Misch, MD - Infectious Diseases • Chris Saddler, MD - Infectious Diseases • James Stein, MD - Cardiology COVID-19 Coagulopathy Workgroup Members: • Matthew Brunner, MD - Hematology • John Hoch, MD - Vascular Surgery • Stephanie Kraus – Nursing • Kraig Kumfer, MD - Hospital Medicine • Margaret Murray, RN - Nursing • Anne Rose, PharmD - Pharmacy • Jon Sheehan, MD - Hematology • James Stein, MD - Cardiology • Philip Trapskin, PharmD - Pharmacy • Eliot Williams, MD - Hematology • Luke Zurbriggen, MD - Hematology Additional Contributors: • David Andes, MD - Infectious Diseases • Bart Caponi, MD - Hospital Medicine • Chris Cassara, MD – Anesthesiology • Joseph Connor, MD – Pathology • Josh Glazer, MD - Emergency Medicine • Kate Hartkopf, PharmD – Pharmacy • Nizar Jarjour, MD – Pulmonology • Hee Soo Jung, MD - Trauma Surgery • Becky MacAllister, MD - Hospital Medicine • Alex MacBriar, MD - Hospitalist Medicine • Doug McNeel, MD - Oncology • Michael Pulia, MD - Emergency Medicine • Nasia Safdar, MD – Infectious Diseases • Lynn Schnapp, MD - Department of Medicine • Dan Shirley, MD - Infectious Diseases • Aaron Steffenhagen, PharmD - Pharmacy • Matthew Swedlund, MD – Family Medicine • Philip Trapskin, PharmD - Drug Policy Program • Jeff Wells, MD - Critical Care Medicine • Scott Wilson, DO - Hospital Medicine • David Yang, MD - Clinical Laboratory Medicine Copyright © 2022 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission. Contact: CCKM@uwhealth.org Last Revised: 10/2022 Effective 10/20/2022. Contact CCKM@uwhealth.org for previous versions 3 Committee Approval(s): COVID-19 Antiviral and Host Immunomodulatory (CONSIDER) Workgroup (October 2022) Inpatient Anticoagulation Committee (October 2022) Pharmacy & Therapeutics Committee (***) Plan for Review: This guideline will be reviewed as dictated and necessary given public health priorities and as clinical evidence evolves. Copyright © 2022 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission. Contact: CCKM@uwhealth.org Last Revised: 10/2022 Effective 10/20/2022. Contact CCKM@uwhealth.org for previous versions 4 Introduction COVID-19 pathogenesis is thought to be caused by two main processes. Early-stage disease is primarily related to SARS-CoV-2 viral replication, while later-stage disease is primarily related to a dysregulated immune response that causes tissue damage. For this reason, COVID-19 therapeutics are expected to be most effective early in the disease course, while anti- inflammatory and immunomodulatory therapies are likely more beneficial in later stages.1 The National institutes of Health (NIH) COVID-19 Treatment Guidelines Panel has developed recommendations for the clinical management of adults. UW Health has agreed to endorse the NIH COVID-19 Treatment Guidelines, with additional recommendations specific to UW Health, such as identification of contraindications to therapeutic anticoagulation (see Appendix). UW Health critically appraises an external guideline with the AGREE-II instrument to assess whether the guideline was developed with an evidence-based process with efforts to limit sources of bias. Endorsement decisions on medication therapy-focused guidelines are ultimately approved by the Pharmacy & Therapeutics Committee. The AGREE tool was not used by the workgroup to appraise the NIH COVID-19 Treatment Guidelines because it is a well-respected national guideline and is felt to provide the most up-to-date, robust review and cumulative analysis of the currently available evidence and expert opinion. Scope • NIH COVID-19 Treatment Guidelines provide recommendations on the therapeutic management of both hospitalized and non-hospitalized adults. Recommendations address the use of antivirals, immunomodulators, monoclonal antibodies, the use of antithrombotics for the prevention of venous thromboembolism, and special considerations in certain clinical scenarios (e.g., co-infection with influenza and SARS- CoV-2, pregnant patients, etc.). • Intended users of this guideline at UW Health are physicians, advanced practice providers, and pharmacists • At present, there is a paucity of high-quality evidence pertaining to the therapeutic management of adults infected with, or at risk of, severe COVID-19. This guideline is expected to undergo further updates as new evidence emerges. Readers should ensure they are consulting the most recent version of the NIH COVID-19 Treatment Guidelines Disclaimer Clinical practice guidelines assist clinicians by providing a framework for the evaluation and treatment of patients. This guideline outlines the preferred approach for most patients. It is not intended to replace a clinician’s judgment or to establish a protocol for all patients. It is understood that some patients will not fit the clinical condition contemplated by a guideline and that a guideline will rarely establish the only appropriate approach to a problem. Copyright © 2022 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission. Contact: CCKM@uwhealth.org Last Revised: 10/2022 Effective 10/20/2022. Contact CCKM@uwhealth.org for previous versions 5 Conflicts of Interest A conflict of interest declaration must be signed/submitted by guideline workgroup and/or committee members to ensure balance, independence, objectivity, and scientific rigor in activities pertaining to the guideline development process. Guideline members must complete a conflict of interest statement annually or as new interest(s) arises. Potential, current and planned future, conflicts of interest will be identified and managed in accordance with institutional policies and procedures. This may include, but is not limited to, conflict disclosure, abstaining from voting, dismissal during comment and voting period, or recusal from requesting and/or participation in the decision-making process. Collateral Tools & Resources The following collateral tools and resources support staff execution and performance of the evidence-based guideline recommendations in everyday clinical practice. Metrics • New COVID-19 admissions (7-day total) • % staffed inpatient beds occupied by COVID-19 patients (7-day average) Order Sets & Smart Sets EUA – Bebtelovimab EUA – IP Adult [9589] IP – COVID-19 – Adult – Supplemental [7044] Pharmacist COVID-19 Pre-Exposure MAB Protocol – Adult & Peds [9350] Patient Resources COVID-19 Vaccines [8226] Protocols COVID-19 Oral Antiviral Therapy Ordering – Adult/Pediatric – Ambulatory [270] Pharmacist COVID-19 Monoclonal Antibody Therapy Ordering – Adult – Ambulatory [253] Pharmacist COVID-19 Monoclonal Antibody Pre-exposure Prophylaxis Ordering – Adult/Pediatric - Ambulatory [271] Copyright © 2022 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission. Contact: CCKM@uwhealth.org Last Revised: 10/2022 Effective 10/20/2022. Contact CCKM@uwhealth.org for previous versions 6 Appendix A. Relative or Absolute Contraindications to Therapeutic Anticoagulation in Hospitalized Patients with COVID-19 UW Health endorses the adult treatment recommendations found within the full NIH COVID-19 Treatment Guideline except for the topic(s) listed in this section; alternative recommendations are described below. • Active bleeding¥ • Planned or anticipated procedures/surgery¥ • Known bleeding within the last 30 days requiring emergency room presentation or hospitalization • Known history of an inherited or active acquired bleeding disorder • Known history of heparin induced thrombocytopenia¥ • Recent ischemic stroke¥ • Platelet count <50K/µL • Hemoglobin <8 g/dL (to minimize the likelihood of requiring red blood cell transfusion if potential bleeding were to occur) • Pregnancy¥ • Dual antiplatelet therapy, when one of the agents cannot be stopped safely • Intracranial surgery or stroke within 3 months¥ • History of intracerebral arteriovenous malformation¥ • Cerebral aneurysm or mass lesions of the central nervous system¥ • Intracranial malignancy¥ • History of intracranial bleeding¥ • History of bleeding diatheses (e.g., hemophilia) • History of gastrointestinal bleeding within previous 3 months¥ • Thrombolysis within the previous 7 days¥ • Presence of an epidural or spinal catheter¥ • Recent major surgery <14 days¥ • Uncontrolled hypertension (sBP >200 mmHg, dBP >120 mmHg) ¥ • Acute or subacute bacterial endocarditis¥ ¥ UW Health-specific recommendation, based on institutional standards and/or expert opinion of guideline workgroup members Copyright © 2022 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission. Contact: CCKM@uwhealth.org Last Revised: 10/2022 Effective 10/20/2022. Contact CCKM@uwhealth.org for previous versions 7 References 1. COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed September 28, 2022. Copyright © 2022 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission. Contact: CCKM@uwhealth.org Last Revised: 10/2022 Effective 10/20/2022. Contact CCKM@uwhealth.org for previous versions