Therapeutic Options for COVID-19 Patients

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

On this page:
Monoclonal Antibody (mAb) Treatment
    Monoclonal antibody treatment and SARS-CoV-2 variants
    Ethical guidance and eligibility
    General resources
    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.

Monoclonal antibody treatment and SARS-CoV-2 variants

Certain circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Health care providers should review the viral neutralization data in the authorized fact sheets for each mAb available under EUA for details regarding specific variants and resistance (see below). Information on the proportion of SARS-CoV-2 variants circulating in the U.S. is available on CDC COVID Data Tracker: Variant Proportions and will be updated regularly.

Variants are increasing in Minnesota, including variants that have decreased susceptibility to bamlanivimab/etesevimab. This is a rapidly evolving area and providers are encouraged to consult with an infectious disease specialist if they have concerns about mAb treatment and variants.

Please note that although sequencing information is helpful on a population level, individual patient results will not be reported back to the provider or submitting laboratory. Whole genome sequencing is not currently approved for use as a diagnostic test to make individual patient treatment decisions. In addition, the lengthy turnaround time for this type of testing means it is unsuitable for treatment decisions involving mAbs, which should be given as soon as possible once a patient has developed symptoms and tests positive.

• CDC COVID Data Tracker: Variant Proportions
• Health Advisory: Pause on Monoclonal Antibody Treatment Bamlanivimab/Etesevimab (PDF)
  MDH health advisory issued on June 28, 2021.
• FDA authorizes revisions to fact sheets to address SARS-CoV-2 variants for monoclonal antibody products under emergency use authorization
  Contains links to FDA fact sheets for each mAb with recently updated definition of high risk for disease progression (i.e., eligibility criteria, Section 2.1 for both) and antiviral resistance (section 15 of each).
• Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab
  April 16, 2021. Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available.
• For questions on mAbs and variants, please contact the MDH Provider Hotline at 651-201-5414, option 3.
• Please visit the MDH Health Advisory: SARS-CoV-2 Variant Surveillance for questions on submitting specimens for genomic sequencing.

Ethical guidance and eligibility

• Ethical Framework for Allocation of Monoclonal Antibodies during the COVID-19 Pandemic (PDF)
  Updated 4/30/21
  
  
• 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 4/19/21
  
  
• Suggested Criteria for Monoclonal Antibody Treatment of COVID-19 in Children (PDF)
  This document contains a suggested list of clinical conditions for providers to consider when prescribing monoclonal antibody therapies for COVID-19 in children.
  Updated 5/28/21

General resources

• HHS Combat COVID: COVID-19 Resources for Healthcare Professionals
  Resources for health care professionals on monoclonal antibodies for high-risk patients.
  • Monoclonal antibodies video and flyer for patients
  • FAQ on billing and reimbursement
  • High-risk patient guidance
  • Review of clinical evidence
  • Videos on counseling patients for monoclonal antibodies
    
    
• HHS/ASPR Federal Response to COVID-19: Monoclonal Antibody Playbook (PDF)
  Outpatient administration playbook for healthcare leadership, updated June 3, 2021.
  
  
• COVID-19 Medication Options
  Includes basic information on monoclonal antibody treatments.
  
  
• National Infusion Center Association: COVID-19 Antibody Therapy Resource Center
  Resources for infusion providers, prescribers, and patients. Includes COVID-19 Antibody Therapy Locator Tool. This tool does not imply current availability of doses. These antibody therapies require a drug order (similar to a prescription) from a health care provider (HCP) for eligible patients.
  
  
• CMS: Coverage of Monoclonal Antibody Products to Treat COVID-19 (PDF)
  Information on Medicare, Medicaid/CHIP, and plans subject to ACA market reforms.
  
  
• CMS: Medicare Monoclonal Antibody Infusion
  Information for health care providers on Medicare payment, billing and coding for monoclonal antibody treatment. Note: On 5/6/2021 CMS increased the Medicare payment rate for administering monoclonal antibodies both in health care settings and at home or temporary lodging.
  • Visit CMS Increases Medicare Payment for COVID-19 Monclonal Antibody Infusions for the full announcement.
  • Visit CMS: COVID-19 Vaccines and Monoclonal Antibodies for information on Medicare billing and payment codes and effective dates for vaccines and therapeutic agents.
    
    
• 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.

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. Visit 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)
  • Resources for Healthcare Providers
    Includes information on packaging and preparation of casirivimab and imdevimab

Eli Lilly – Bamlanivimab and Etesevimab

Bamlanivimab/etesevimab is now available for use through HHS. Etesevimab may be shipped alone for combination with existing supplies of bamlanivimab or as a combination product.

• Eli Lilly: Bamlanivimab and etesevimab Emergency Use Authorization for the Treatment of COVID-19
  Website of the manufacturer of bamlanivimab and etesevimab. Visit 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
• 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)