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.
As of 4/16/2021, the FDA has revoked the emergency use authorization (EUA) for bamlanivimab, when administered alone, for the treatment of mild-to-moderate COVID-19 in patients at high risk of disease progression or hospitalization. See the FDA announcement Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab. Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available.
Bamlanivimab should no longer be prescribed alone for use in patients with mild to moderate COVID-19 illness. Infusion sites that are using bamlanivimab can order etesevimab alone, bamlanivimab, or casirivimab/imdevimab using the direct ordering process at HHS: Overview of Direct Order Process for COVID-19 Therapeutics. For any infusion sites that have only bamlanivimab on hand and need an alternative supply in the short term, please reach out to your regional health care coalition.
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 US is available on the CDC website and will be updated regularly (see below).
Variants are increasing in Minnesota. However, the most common variant identified in Minnesota is B.1.1.7 (also known as the UK variant), which is not thought to impact the efficacy of the two currently available monoclonal treatments. Other variants may have decreased susceptibility to bamlanivimab/etesevimab. These include the B.1.427/9 variants, first identified in California, which is increasing in Minnesota but to a lesser degree than B.117. Other potentially resistant variants that have been found in Minnesota include P.1, B.1.351, and some strains of B.1.525/6, but are currently thought to be at a low prevalence. 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.
- 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 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. - CDC: Variant Proportions in the U.S.
- For questions on mAbs and variants, please contact the MDH Provider Hotline at 651-201-5414, option 3.
- Please see 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
- Screening Tool for Monoclonal Antibody Treatment (PDF)
Clinical screening tool to identify eligible individuals for facilities administering the treatment.
Updated 4/19/21
- 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 4/19/21
General resources
- HHS Combat COVID: COVID-19 Resources for Healthcare Professionals
Resources for health care professionals on monoclonal antibodies for high-risk patients.- Monoclonal antibioties video and flyer for patients
- FAQ on billing and reimbursement
- High-risk patient guidance
- Review of clinical evidence
- HHS/ASPR Therapeutics: Monoclonal Antibody Playbook (PDF)
Outpatient administration playbook for facilities setting up infusion clinics, updated April 16, 2021.
- COVID-19 Medication Options
Includes basic information on monoclonal antibody treatments.
- 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.
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 may be shipped alone for combination with existing supplies of bamlanivimab or as a combination product.
- 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 - 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:
COVID-19 information in other languages:
- Kab Mob Khaus Las Nas Vais Lav 2019 (COVID-19)
(Hmong) - Cudurka Koronafayras 2019 (COVID-19)
(Somali) - Enfermedad del Coronavirus 2019 (COVID-19)
(Spanish) - American Sign Language (ASL) Videos
Contact us:
If you have questions or comments about this page, use our IDEPC Comment Form or call 651-201-5414 for the MDH Infectious Disease Epidemiology, Prevention and Control Division.