COVID-19 Medication Options - Minnesota Dept. of Health

COVID-19 Medication Options

Monoclonal antibodies

Monoclonal antibody medications for COVID-19 include bamlanivimab/etesevimab, casirivimab/imdevimab, sotrovimab, and tixagevimab/cilgavimab. These medications are used at different times, including for the prevention and treatment of illness due to COVID-19. They are authorized for the treatment of outpatients only, not patients who have been admitted to the hospital with COVID-19.

Antibodies are proteins that people's bodies make to fight viruses, such as the virus that causes COVID-19. Antibodies made in a laboratory act a lot like natural antibodies to limit the amount of virus in your body. They are called monoclonal antibodies.

Antibodies can be given into a vein by intravenous (IV) infusion or into the skin by subcutaneous (SQ) injection. Antibodies may be administered only in settings where health care providers have immediate access to medications to treat any reactions and where emergency medical systems are available, if needed.

Monoclonal antibody treatments are allowed by the U.S. Food and Drug Administration (FDA) under an emergency use authorization (EUA) while clinical studies continue to look at their usefulness and safety.

COVID-19 Medication (PDF)
Handout summary of when monoclonal antibodies are used to prevent and treat COVID-19.

Products Bamlanivimab/ Etesevimab REGEN-COV
(Casirivimab/ imdevimab)
Sotrovimab EVUSHELD
(Tixagevimab/ Cilgavimab)
Authorized use(s) Treatment of mild to moderate symptoms

Prevention: post-exposure prophylaxis (PEP)*
Treatment of mild to moderate symptoms

Prevention: post-exposure prophylaxis (PEP)*
Treatment of mild to moderate symptoms Prevention: before exposure
Age eligibility All ages Ages 12 years and older Ages 12 years and older Ages 12 years and older
Weight eligibility At least 2.2 pounds or more 88 pounds or more 88 pounds or more 88 pounds or more
Other criteria for treatment Test positive for SARS-CoV-2

Be within 10 days of the start of symptoms

Not be hospitalized
Test positive for SARS-CoV-2

Be within 10 days of the start of symptoms

Not be hospitalized
Test positive for SARS-CoV-2

Be within 10 days of the start of symptoms

Not be hospitalized
Not applicable
Other criteria for prevention Must not be fully vaccinated against COVID-19
OR
Not expected to have immune response to vaccine**
Must not be fully vaccinated against COVID-19
OR
Not expected to have immune response to vaccine**
Not applicable Weakened immune system and not expected to respond to COVID vaccine
OR
Unable to get a COVID-19 vaccine for medical reasons
EUA Fact sheet for patients, parents, caregivers (English) EUA of Bamlanivimab and Etesevimab (PDF) EUA of REGEN-COV™ (casirivimab and imdevimab) (PDF) EUA of Sotrovimab (PDF) EUA of Evusheld™ (tixagevimab co-packaged with cilgavimab) (PDF)
Fact sheets for patients, parents, caregivers (Spanish) EUA de bamlanivimab y etesevimab (PDF) EUA de REGEN-COV™ (casirivimab con imdevimab) (PDF) EUA de Sotrovimab (PDF) Not available

*Post-exposure prophylaxis (PEP) is for people who have had close contact or are at high risk of having had close contact with someone with COVID-19, such as people in the same institutional setting (for example, nursing homes or prisons) where COVID-19 is circulating.

**Are not expected to build up enough of an immune response to the complete COVID-19 vaccination (for example, someone with immunocompromising conditions, including someone who is taking immunosuppressive medications).

When demand for monoclonal antibody (mAb) treatments increases, the Minnesota health care system works to prioritize access to the treatments to people who are most at risk of severe illness.

  • The Minnesota Department of Health has worked closely with the Mayo Clinic and the University of Minnesota to look at who benefits from monoclonal antibody treatment. When a lot of COVID-19 is in the community and demand for the treatments is high, priority will be given first to treating patients who are ill and who have the highest risk of developing severe illness and requiring hospital admission. This means that some lower-risk patients who are eligible for treatment will be notified that an appointment is not immediately available. Patients should remain in contact with their provider and watch closely for any symptoms.
  • During times of high demand, those who have been exposed but do not have symptoms may not have access to monoclonal antibodies for prevention of COVID-19 until case counts and demand for monoclonal antibody treatment decreases. People who have been exposed should be in contact with their provider and watch closely for any symptoms. If symptoms develop and they test positive for COVID-19, they may then seek treatment.
  • These priority categories apply to patients age 18 years and older. Children who are eligible for mAb treatment under the current FDA guidance should continue to be assessed and treated, as they have been. Refer to Suggested Criteria for the Use of Monoclonal Antibody Therapy for COVID-19 in Children (PDF).

This approach was developed by MDH in consultation with the Minnesota COVID-19 Ethics Collaborative and MDH Science Advisory Team, similar to previous guidance on scarce therapeutics. Full details are available at Ethical Framework for Allocation of Monoclonal Antibodies during the COVID-19 Pandemic (PDF).

  • Aged 65 years or older
  • Obesity (BMI of 35 kg/m2 or greater)
  • Diabetes
  • Chronic kidney disease
  • Cardiovascular disease (disease of the heart and blood vessels as one body system) in patients aged 55 years or older
  • Chronic lung disease in patients aged 55 years or older
  • Hypertension (high blood pressure) in patients aged 55 years or older
  • Immunocompromised (hard to fight off or unable to fight off disease)
  • Pregnancy

Talk to your doctor or other health care provider about treatments that are right for you, including if you have other medical conditions that are not listed above.

Clinical trials for all three monoclonal antibodies authorized for treatment of symptoms of COVID-19 have shown a decrease in hospitalizations and emergency room visits and a decrease in the amount of virus in an infected person's blood. So far, clinical trials have shown that these treatments can reduce the risk of hospitalization with severe COVID-19 and death by 70-85%.

Clinical trial data for the use of monoclonal antibodies for post-exposure prevention of or protection from disease (prophylaxis) showed that treatment reduced the risk of COVID-19 after an exposure by about 60-80%. Clinical trial data for the use of Evusheld (tixagevimab/cilgavimab) for pre-exposure prevention or protection (prophylaxis) reduced the risk of COVID-19 by 77%.

NOTE: Studies are still going on to assess these treatments and not everyone may see these benefits, especially those with severely weakened immune systems or co-morbidities (several medical conditions at the same time).

Monoclonal antibody treatment may have side effects. The most common reported side effects include:

  • Bamlanivimab/etesevimab: nausea, dizziness, itching, and rash.
  • Casirivimab/imdevimab: nausea, vomiting, hyperglycemia, and pneumonia.
  • Sotrovimab: itching, fever, rash, and diarrhea.
  • Tixagevimab/cilgavimab: headache, fatigue, and cough.

The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site. Additionally, because bamlanivimab/etesevimab, casirivimab/imdevimab, sotrovimab, and tixagevimab/imdevimab are antibody treatments, they could affect your body's own immune response to future infections with SARS-CoV-2, the virus that causes COVID-19, or they could affect your immune response to a vaccine for COVID-19.

Allergic reactions including hypersensitivity reactions (such as itching or flushing) and anaphylaxis (shock or other physical reactions to a substance) have been reported in clinical trials of casirivimab/imdevimab, bamlanivimab/etesevimab, and sotrovimab. These allergic reactions are very rare and in all cases were successfully treated and resolved. Clinical studies are ongoing to evaluate the usefulness and safety of antibody treatment. It is possible that some risks are still unknown.

In the study of Evusheld (tixagevimab/cilgavimab), more patients in the treatment group had cardiac events, such as heart attacks, heart failure, and abnormal heart rhythms, compared to the patients in the placebo group. These numbers were small (0.6% for Evusheld, 0.2% for placebo) and all cardiac events happened in patients who already had cardiovascular disease or risk factors for cardiovascular disease before treatment. It has not been established whether there is a causal link between Evusheld and these cardiac events. Patients with cardiovascular disease or who are at high risk for cardiac events should discuss the risks and benefits of Evusheld treatment with their provider.

Pregnant women and their babies are at high risk for serious illness from COVID-19. Women who are pregnant should talk with their doctor or other health care provider. There is no specific safety data on the use of monoclonal antibodies for COVID-19 in pregnancy. However, pregnant women have been successfully receiving these treatments since November 2020. Monoclonal antibody treatment for pregnant women with symptoms of COVID-19 is recommended by the National Institutes of Health and the American College of Obstetricians and Gynecologists (ACOG).

There is no available data on the presence of lab-made antibodies in human or animal milk, the effects on breastfed infants, or the effects on milk production. However, ACOG recommends that breastfeeding is not a contraindication (does not make someone medically unable)for the use of monoclonal antibodies. There is no need to temporarily stop breastfeeding when receiving monoclonal antibodies.

COVID-19 Monoclonal Antibody Use in Pregnancy (PDF)
This joint statement from the Minnesota Department of Health (MDH), Minnesota section of the American College of Obstetricians and Gynecologists (MN ACOG), Allina Health, Mayo Clinic, and University of Minnesota summarizes the risks of COVID-19 in pregnancy, pregnancy-specific data and recommendations related to mAb therapy, and how Minnesotans can access mAb therapy.
Updated 1/10/22

ACOG: COVID-19 FAQs for Obstetrician-Gynecologists, Obstetrics

CDC: Considerations for Newborns and Breastfeeding

We do not yet know how effective vaccines are in someone who has previously received an antibody treatment for a COVID-19 infection, or whether the antibody treatment could interfere with your body's own immune response to a vaccine. Once you have had COVID-19, you are very unlikely to be reinfected for three months afterward. So, if you receive an antibody treatment, you should delay receiving a vaccine for three months, as a precaution.

It is important to know that if you have already received a vaccine for COVID-19, you are still eligible for antibody treatment. You may be treated with monoclonal antibodies whether you have received one or two doses of vaccine. If you have only received one dose of vaccine, you should delay receiving the second dose for three months after treatment, but you do not have to start the vaccine series over again. For patients receiving Evusheld, this treatment should be administered at least two weeks after receiving a COVID-19 vaccine.

CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States

The federal government distributed antibody supplies at no cost to patients. However, some hospitals may have billed insurance companies to administer the drug. The state of Minnesota is working to ensure that any location that gives antibody treatments is considered in network and covered by insurance. However, if you are treated at a health care facility outside of your usual network, it is possible that you may have additional out-of-pocket charges (for example, if an E-Health visit is necessary to confirm eligibility).

How can I get monoclonal antibody treatment?

The Minnesota Resource Allocation Platform (MNRAP) is an online tool that connects people and health care providers with COVID-19 medications. People, their caregivers, or their health care providers may use MNRAP to find out which medications are available, whether they will help the person, and whether the person is able to get medication.

If someone can get a COVID-19 medication, MNRAP passes along information on their behalf to a health care facility that can give it. A final decision about whether someone may get a medication is up to the health care provider at that facility.

Please note: Evusheld (tixagevimab/cilgavimab) is not available via MNRAP. Patients who believe they may be eligible for treatment with Evusheld should speak to their provider about eligibility.

  • The online screening form will ask about your age, medical history, symptoms, location, and your contact information. The questions will determine whether you may have a qualifying high-risk condition and if you are within the treatment window.
  • You may complete the screening form yourself or ask your provider, caregiver, or trusted friend or family member to complete it for you. Providers should select the button "For Health Care Providers."
  • When you finish filling out the screening form, you will be notified whether you meet the basic criteria for a monoclonal antibody treatment and whether there is an appointment available.
  • The system will match you to the closest available appointment to you, based on your ZIP code. You will also be given the option to select an alternative location if there are other appointments available.
  • Once you hit "submit," MNRAP will send your information to the facility you have selected. Duplicate entries are not allowed, so you will not be able to submit a second time unless it is for a different reason (for example, treatment instead of prevention).
  • You will receive an email confirming your MNRAP submission and the contact information of the treatment facility where your referral has been sent. If you do not have an email address, please provide a phone number. You may also ask a friend, family member or your provider to fill out the form for you. If your provider, caregiver, friend or family member has completed the form for you, they can provide their email address or yours. If you are unable to provide an email address for the confirmation email, your referral will still be sent to the treatment facility.
  • A provider should then contact you from that facility, by the next business day, to confirm your eligibility and schedule your appointment. They may require additional information for this, such as medical or prescription records if you are not a patient at that facility. If your provider, caregiver, friend, or family member has completed the form for you, they will be given the option to provide their contact information and to schedule the appointment on your behalf.

PLEASE NOTE:

  • Appointments are limited, especially on Fridays, Saturdays, and Sundays. If you do not accept an appointment when offered, you may not be able to get another one.
  • Please ensure you have selected the right treatment facility before you hit submit. Write down the name and address for that site.
  • MDH and MNRAP do not make the final decision about who can get a medication. The final decision is up to the health care provider at the treating facility. MNRAP screens patients for initial eligibility and sends patient information to treatment facilities for consideration. Individual treatment decisions are up to health care providers.
  • MDH and MNRAP do not control the number or location of available appointments. The platform is designed to connect patients and providers to the appointments that are currently available from health care facilities. MNRAP will match you to the closest available appointment, but if demand is high, treatment facilities closer to you may not have open slots.
  • If after submitting your form and receiving an email you do not hear from your selected facility by the next business day of submitting your MNRAP request, please contact them directly. The contact information for the facility will be in your confirmation email. Your appointment is not confirmed until you are contacted by the treating facility and scheduled. Please answer your phone calls from unknown numbers – it may be the facility trying to contact you.
  • When a lot of COVID-19 is in the community and demand for the treatments is high, priority will be given first to treating patients who are ill and who have the highest risk of developing severe illness and requiring hospital admission. This means that some patients, who are eligible for treatment, will be notified that an appointment is not immediately available.
  • If more appointments become available after other patients have been treated, you may be contacted. Please stay in contact with your health care provider and watch closely for any symptoms.
  • MDH and MNRAP do not make the final decision about who can get a medication. The final decision is up to the health care provider at the treating facility.

For patients or
caregivers
     For health care
providers

Oral antivirals

New treatments of COVID-19 that are administered orally (by mouth) have received emergency use authorization from the FDA. Limited amounts of the oral antivirals molnupiravir and nirmatrelvir/ritonavir (Paxlovid) are being allocated to states. Further details will be posted as soon as available.

COVID-19 Medications: Antivirals (PDF)
Handout summary of when antivirals are used to treat COVID-19.

Evusheld (tixagevimab/cilgavimab)

On Dec. 8, 2021, the FDA issued an emergency use authorization (EUA) for a new monoclonal antibody therapy named Evusheld (tixagevimab/cilgavimab). Unlike other currently available monoclonal antibodies, Evusheld is a long-acting antibody that has been authorized for use only to prevent or protect someone before they are exposed to COVID-19. Evusheld is not for the treatment of symptoms due to COVID-19 and is not given following an exposure to someone with COVID-19; it is given to prevent infection before an exposure.

Evusheld is NOT a substitute for COVID-19 vaccination. All patients for whom COVID-19 vaccination is recommended, including those with compromised immune systems, should receive COVID-19 vaccination.

COVID-19 Medications: Evusheld (PDF)
Handout summary of when Evusheld is used to prevent COVID-19.

The U.S. government has purchased supplies of this antibody therapy and will be allocating it to states. It is anticipated that at the start, Evusheld (tixagevimab/cilgavimab) will be in very short supply. MDH has issued interim guidance for providers and patients on how supplies will be allocated to facilities and which patients should be prioritized when supplies are scarce. This guidance can be found at Therapeutic Options for COVID-19 Patients: Ethical guidance and eligibility. Patients who may be eligible for treatment should discuss their eligibility and the availability of Evusheld with their provider.

Remdesivir and convalescent plasma

These medication options are typically for people with severe COVID-19 who require hospitalization.

More information

For more information on COVID-19 treatments and vaccines, please visit Combat COVID provided by the U.S. Department of Health and Human Services (HHS).

  • Combat COVID Monoclonal Antibodies Call Center is a helpline to help you make a decision about whether you may be eligible for a COVID-19 treatment. Note: this is not an MDH helpline.
    • English: 1-877-332-6585
    • Spanish: 1-877-366-0310

Updated Friday, 21-Jan-2022 15:14:39 CST