Therapeutic Options for COVID-19 Patients

Information about investigational therapeutics to be updated as new information emerges.

On this page:
Monoclonal Antibody (mAb) Treatment
    Ethical guidance and eligibility
    General resources
    Eli Lilly - Bamlanivimab (BAM)
    Regeneron - Casirivimab and Imdevimab
    Eli Lilly – Bamlanivimab and Etesevimab
Ventilators and Cardiopulmonary Resuscitation
Remdesivir

Monoclonal Antibody (mAb) Treatment

Monoclonal antibody treatments are available through the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for non-hospitalized COVID-19 positive people.

Ethical guidance and eligibility

• Ethical Framework for Allocation of Monoclonal Antibodies during the COVID-19 Pandemic (PDF)
  2/12/21
  
  
• Screening Tool for Monoclonal Antibody Treatment (PDF)
  Clinical screening tool to identify eligible individuals for facilities administering the treatment.
  Updated 3/2/21
  
  
• Exposure Assessment for Critical Workers with Job-related Risk of COVID-19 (PDF)
  This document is for health care providers to determine a patient's critical worker status and occupational risk.
  Updated 2/12/21

General resources

• HHS: Monoclonal Antibodies for High-Risk COVID-19 Positive Patients
  General information on monoclonal antibody treatments and other COVID-19 treatment options.
  
  
• Monoclonal Antibody Treatment: Frequently Asked Questions
  Updated 2/8/21
  
  
• National Infusion Center Association: COVID-19 Monoclonal Antibody Infusion Center Locator
  Infusion sites displayed in this tool have been authorized to administer antibody treatments for COVID-positive patients under Emergency Use Authorization, but their inclusion in this tool does not imply current availability of doses. These antibody therapies are restricted to certain high-risk patients and require a drug order (similar to a prescription) from a Health Care Provider (HCP) for eligible patients. HCPs must verify eligibility of their patients and verify the availability of doses at an authorized infusion site before they refer an eligible patient to schedule an appointment to receive treatment at an authorized infusion site.
  If you have difficulty navigating the site, please see the National Infusion Center Association COVID-19 Antibody Treatment: Resource Center.
  
  
• CMS: Insurance Coverage of Monoclonal Antibody Treatment
  Information on Medicare, Medicaid/CHIP, and plans subject to ACA market reforms.
  
  
• CMS: Medicare Monoclonal Antibody Infusion Program Instructions
  Information for health care providers on Medicare payment, billing and coding for monoclonal antibody treatment.
  
  
• FDA: Drug Supply Chain Security Act (DSCSA)
  Guidance for industry on how prescription drug products related to the treatment of COVID-19 (including monoclonal antibodies) can be exempted from certain requirements of the Drug Supply Chain Security Act (DSCSA).
  
  
• HHS/ASPR: Portfolio of COVID-19 Medical Countermeasures
  Dashboards tracking allocation of monoclonal antibodies by state.

Eli Lilly - Bamlanivimab (BAM)

• Emergency Use Authorization of Bamlanivimab for COVID-19 (PDF)
  Fact sheet for patients.
  11/16/20
  
  
• Eli Lilly: Bamlanivimab for COVID-19
  Website of the manufacturer of bamlanivimab. See additional links, resources, and guidance to facilities administering the treatment, including:
  • FDA letter of authorization
  • Fact sheet for health care providers
  • Fact sheet for patients, parents, and caregivers in English and Spanish
  • Bamlanivimab Antibody Playbook
  • Product image and antibody manufacturing photos
  
  
• FDA: Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab (PDF)

Regeneron - Casirivimab and Imdevimab

• Regeneron: Casirivimab and Imdevimab EUA Guidebook (PDF)
  Product information for providers and infusion sites.
  
  
• Regeneron: Authorized for FDA Emergency Use only Casirivimab and Imdevimab
  Website of the manufacturer of casirivimab and imdevimab. See additional links, resources, and guidance to facilities administering the treatment, including:
  • FDA letter of authorization
  • Fact sheet for U.S. health care providers
  • Fact sheet for patients and caregivers in English and Spanish
  • Dear Healthcare Provider letter (prescribing information)
  • Information on packaging and preparation of casirivimab and imdevimab

Eli Lilly – Bamlanivimab and Etesevimab

Bamlanivimab/etesevimab is now available for use through HHS. This product will be shipped as a combination product. Etesevimab will not be shipped alone and cannot be used as a singular infusion product. There are NO recommendations currently to use this therapy preferentially to bamlanivimab monotherapy. Facilities should continue to treat eligible patients with bamlanivimab as they have been doing.

• FDA: Emergency Use Authorization 094 (PDF)
  Letter for Emergency Use Authorization of Bamlanivimab/Etesevimab for COVID-19, issued 2/9/21.

Ventilators and Cardiopulmonary Resuscitation

• Allocation of Ventilators & Related Scarce Critical Care Resources During the COVID-19 Pandemic (PDF)
  Statewide ethical guidance for the allocation of ventilators during COVID-19.
  5/4/20
  
  
• Hospital Guidance: Making Cardiopulmonary Resuscitation Decisions in the Context of the COVID-19 Pandemic (PDF) 
  Statewide ethical guidance for acute care hospitals and performing CPR during COVID-19.
  7/31/20

Remdesivir

Remdesivir is available through the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for people with severe COVID-19.

• Ethical Framework to Allocate Remdesivir in the COVID-19 Pandemic (PDF)
  Past guidance, key ethical values, and the process for allocation of remdesivir among Minnesota health care facilities and patients.
  Updated 9/17/20
  
  
• Update: Distribution of Veklury® (remdesivir) (PDF)
  Process for hospitals to order supplies of remdesivir.
  10/1/20
  
  
• Patient Information Sheet for Remdesivir (Veklury®)
  9/3/20
  • Patient Information Sheet for Remdesivir (Veklury®) in Hmong
  • Patient Information Sheet for Remdesivir (Veklury®) in Karen
  • Patient Information Sheet for Remdesivir (Veklury®) in Somali
  • Patient Information Sheet for Remdesivir (Veklury®) in Spanish


• Gilead: Remdesivir Emergency Use
  FDA Emergency Use Authorization Letter and patient/caregiver fact sheets in English and Spanish.
  Additional translated fact sheets for patients and parents/caregivers provided by Mayo Clinic:
  • Emergency Use Authorization (EUA) of Remdesivir For Coronavirus Disease 2019 (COVID-19): Hmong (PDF)
  • Emergency Use Authorization (EUA) of Remdesivir For Coronavirus Disease 2019 (COVID-19): Somali (PDF)