Clinician Toolkit

COVID-19 Frontline TeleECHO Enduring: A Light in the Darkness: New Virus-neutralizing Monoclonal Antibodies and Other Point-of-Care Therapies Recently Granted Emergency Use Authorization for Patients with COVID-19

When:
May 3, 2021 @ 12:00 am – May 3, 2022 @ 11:45 pm
2021-05-03T00:00:00+00:00
2022-05-03T23:45:00+00:00

COVID-19 Frontline TeleECHO Enduring: A Light in the Darkness: New Virus-neutralizing Monoclonal Antibodies and Other Point-of-Care Therapies Recently Granted Emergency Use Authorization for Patients with COVID-19

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FACULTY


Christopher Palma, MD, ScM
Assistant Professor of Medicine
University of Rochester
Rochester, NY

PROGRAM OVERVIEW

The COVID-19 FRONTLINE TeleECHO session provides a comprehensive and up-to-date perspective on the ever-changing management of patients with COVID-19. This recording features in-depth case studies to encourage retention of the lessons and provide new perspectives on the management of patients during the COVID-19 pandemic. The case studies will focus on different issues facing clinicians, such as identifying patients who would benefit from monoclonal antibody therapy and best practices for incorporating agents authorized for emergency use into the care of hospitalized and non-hospitalized patients with COVID-19. Strategies for administering neutralizing monoclonal antibodies, such as referral to local infusion centers or developing in-clinic infusion capabilities, will also be discussed.

TARGET AUDIENCE

This CME initiative is designed for HCPs who are involved in the care and treatment of patients with COVID-19 in an outpatient setting, including physicians, NPs, PAs, nurses, pharmacists and paramedics.

LEARNING OBJECTIVES

Upon the completion of this program, attendees should be able to:

  • Assess the rationale for the use of neutralizing monoclonal antibody therapies in recently diagnosed COVID-19 patients to prevent the development of severe disease
  • Critique the efficacy and safety of new virus-neutralizing monoclonal antibody therapies and other therapies approved for emergency use in all patients who test positive for COVID-19
  • Develop in-clinic infusion capability in order to administer new virus-neutralizing monoclonal antibodies to patients with COVID-19 at the point-of-care

ACCREDITATION STATEMENT

Med Learning Group is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

This CME activity was planned and produced in accordance with the ACCME Essentials.

CREDIT DESIGNATION STATEMENT

Med Learning Group designates this virtual activity for a maximum of 1.0 AMA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the virtual activity.

NURSING CREDIT INFORMATION

Purpose: This program would be beneficial for nurses involved in the treatment of patients with COVID-19.
Credits: 1.0 ANCC Contact Hour.

CNE ACCREDITATION STATEMENT

Ultimate Medical Academy/CCM is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. Awarded 1.0 contact hour of continuing nursing education of RNs and APNs.

ABIM Maintenance of Certification

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.0 Medical Knowledge MOC point in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

DISCLOSURE POLICY STATEMENT

In accordance with the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support, educational programs sponsored by Med Learning Group must demonstrate balance, independence, objectivity, and scientific rigor. All faculty, authors, editors, staff, and planning committee members participating in an MLG-sponsored activity are required to disclose any relevant financial interest or other relationship with the manufacturer(s) of any commercial product(s) and/or provider(s) of commercial services that are discussed in an educational activity.

DISCLOSURE OF CONFLICTS OF INTEREST

Christopher Palma, MD, ScM discloses that he has been contracted for research for Regeneron.

CME Content Review
The content of this activity was independently peer reviewed.
The reviewer of this activity has nothing to disclose.

CNE Content Review
The content of this activity was peer reviewed by a nurse reviewer.
The reviewer of this activity has nothing to disclose.

Staff, Planners, and Managers
The staff, planners, and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME/CE activity:
Matthew Frese, MBA, General Manager of Med Learning Group, has nothing to disclose.
Christina Gallo, SVP, Educational Development for Med Learning Group, has nothing to disclose.
Diana Tommasi, PharmD, Medical Director for Med Learning Group, has nothing to disclose.
Lauren Welch, MA, VP, Accreditation and Outcomes for Med Learning Group, has nothing to disclose.
Lisa Crenshaw, Senior Program Manager for Med Learning Group, has nothing to disclose.
Russie Allen, Accreditation and Outcomes Coordinator for Med Learning Group, has nothing to disclose.
Morgan Kravarik, Program Coordinator for Med Learning Group, has nothing to disclose.

DISCLOSURE OF UNLABELED USE

Med Learning Group requires that faculty participating in any CME activity disclose to the audience when discussing any unlabeled or investigational use of any commercial product or device not yet approved for use in the United States.

During this lecture, the faculty may mention the use of medications for both FDA-approved and non-approved indications.

METHOD OF PARTICIPATION

There are no fees for participating and receiving CME credit for this web-based virtual activity. To receive CME/CNE credit participants must:

  1. Read the CME/CNE information and faculty disclosures.
  2. Participate in the web-based enduring activity.
  3. Submit the evaluation form to Med Learning Group.

You will receive your certificate upon completion.

DISCLAIMER

Med Learning Group makes every effort to develop CME activities that are science based. This activity is designed for educational purposes. Participants have a responsibility to use this information to enhance their professional development in an effort to improve patient outcomes. Conclusions drawn by the participants should be derived from careful consideration of all available scientific information. The participant should use his/her clinical judgment, knowledge, experience, and diagnostic decision making before applying any information, whether provided here or by others, for any professional use.

For CME questions, please contact Med Learning Group at [email protected].

RELEASE DATE: May 3, 2021

EXPIRATION DATE: May 3, 2022

Contact this CME provider at Med Learning Group for privacy and confidentiality policy statement information at www.medlearninggroup.com/privacy-policy/

Copyright © 2021 Med Learning Group. All rights reserved. These materials may be used for personal use only. Any rebroadcast, distribution, or reuse of this presentation or any part of it in any form for other than personal use without the express written permission of Med Learning Group is prohibited.

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Updates in the Treatment and Prevention of COVID-19​

Bebtelovimab Is the Only Monoclonal Antibody That Retains Activity Against Omicron Subvariants

The Omicron subvariants BA.2 and BA.2.12.1 now account for 99% of all COVID-19 cases in the United States. Studies assessing the neutralizing activity of monoclonal antibodies for the treatment of COVID-19 have found that only bebtelovimab retains activity against BA.2 and BA.2.12.1. Other monoclonal antibodies, including sotrovimab, bamlanivimab, etesevimab, casirivimab, and imdevimab, are not effective against these new subvariants and are not currently authorized by the US Food and Drug Administration (FDA) to treat COVID-19 due to the high incidence of Omicron BA.2.

Bebtelovimab is authorized for emergency use by the FDA for the treatment of mild-to-moderate COVID-19 in patients 12 years and older weighing at least 40 kg with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death. Bebtelovimab should be administered as soon as possible after positive SARS-CoV-2 results and within 7 days of symptom onset.

FDA Approves Baricitinib for Hospitalized COVID-19 Patients

Baricitinib, an oral Janus kinase (JAK) inhibitor, is now FDA-approved for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). It is also authorized for emergency use by the FDA for hospitalized pediatric patients between 2 and 18 years of age who require oxygen support. The approval of baricitinib is based on efficacy and safety data from the ACTT-2 and COV-BARRIER clinical trials. In ACTT-2, baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time, particularly in patients receiving high-flow oxygen or noninvasive ventilation (10 days vs 18 days; rate ratio for recovery, 1.51; 95% confidence interval (CI), 1.10 to 2.08). The 28-day mortality was 5.1% with baricitinib plus remdesivir and 7.8% with remdesivir alone (hazard ratio [HR] for death, 0.65; 95% CI, 0.39 to 1.09). The COV-BARRIER trial found that baricitinib, in addition to standard of care (SoC), was associated with reduced 28-day mortality in hospitalized adults with COVID-19 compared with SoC alone (8% vs 13%; HR, 0.57; 95% CI, 0.41 to 0.78; P= .0018). The 60-day all-cause mortality was 10% with baricitinib plus SoC versus 15% with SoC (P= .005).

References:
Baricitinib fact sheet for healthcare providers. May 2022. (https://www.fda.gov/media/143823/download).  Accessed 5.24.2022.

Baricitinib (Olumiant®) PI 2022 (https://pi.lilly.com/us/olumiant-uspi.pdf). Accessed 5.24.2022.

Bebtelovimab fact sheet for healthcare providers. May 2022. (https://www.fda.gov/media/156152/download).  Accessed 5.24.2022.

Centers for Disease Control and Prevention (CDC). COVID data tracker. May 23, 2022. (https://covid.cdc.gov/covid-data-tracker/#variant-proportions). Accessed 5.24.2022.

Iketani S, et al. Antibody evasion properties of SARS-CoV-2 Omicron sublineages. Nature. 2022;604:553-556.

Kalil AC, et al. Baricitinib plus remdesivir for hospitalized adults with COVID-19. N Engl J Med. 2021;384:795-807.

Marconi VC, et al. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial. Lancet Resp Med. 2021;9:1407-1418.