COVID-19

In a healthy immune system, antibodies are produced by white blood cells in response to a foreign invader. Antibodies fight off infection by attaching to foreign proteins called antigens to destroy or neutralize them. For example, when you are exposed to a virus, your body produces antibodies to help rid your system of the infection.
 
Monoclonal antibodies are laboratory-produced antibodies designed to locate and bind to certain molecules, rendering them neutral in a similar way.
 
First developed in the 1970s, dozens of monoclonal antibody therapies are available today. They fall into three main categories:

• Anti-inflammatory
• Anti-cancer
• Anti-viral

Currently, there are three monoclonal antibody treatments available in the United States to treat COVID-19 with Emergency Use Authorization from the FDA.
 

Monoclonal antibody treatment is available to individuals who:

• Patients 65 years of age or older

                          OR

• Are high risk for developing severe COVID-19 AND
• Have a positive COVID-19 test and have not yet been admitted to the hospital AND
• Are 18 years of age or older
  • Children 12 years of age or older (and at least 88 pounds) may be eligible after a discussion with their pediatrician or primary care provider

Important:
In some cases, direct exposure isn't a criterion. If you meet the criteria above and are at high risk of exposure to an individual infected because of an occurrence of infection in other individuals in the same institutional setting (for example: a nursing home), you are eligible for post-exposure preventive monoclonal antibodies.
 
It is important to understand that post-exposure preventive monoclonal antibodies are not a replacement for vaccination. We highly encourage everyone to get a COVID-19 vaccine.
 
Eligibility is determined by your primary care provider or the monoclonal antibody care team and is based on the following high-risk criteria:
 

• 65 years of age or older
• Overweight (body mass index over 25)
• Pregnancy
• Chronic kidney disease
• Diabetes (Type 1 and Type 2)
• Weakened immune system
• Currently receiving immunosuppressive treatment
• Cardiovascular disease/hypertension
• Chronic lung disease
• Sickle cell disease
• Neurodevelopmental disorders
• Medical-related technological dependence

Monoclonal antibody therapy is most effective when taken as early in the disease course as possible. So, the sooner the better — even if you're not feeling sick. In high-risk patients, receiving treatment earlier, when symptoms are less severe, may help prevent hospitalization.
 

Monoclonal antibody therapy is an intravenous (IV) infusion. These infusions are given in one of our outpatient care centers and require about an hour to administer, followed by an hour of observation and monitoring. In certain settings it may be administered by an injection.  This decision will be made by the clinical team and will be discussed with you.
 

One possible side effect of monoclonal antibody therapy is an allergic reaction, which is why patients are required to wait for an hour after administration. These reactions typically occur during infusion or soon after, and your care team will closely monitor you for any signs of an allergic reaction.
 
In case of a rare, delayed reaction we advise you to contact your doctor or care team immediately if you notice any of the following signs of an allergic reaction:

• Fever and/or chills
• Nausea
• Headache
• Shortness of breath
• Low blood pressure
• Wheezing
• Swelling of lips, face, or throat
• Muscle aches
• Hives or itchiness
   

When administered for preventive use, monoclonal antibody therapy may be given as a subcutaneous injection.
 

No.  Anyone who has tested positive for COVID-19 needs to isolate — regardless of whether or not they have received monoclonal antibody therapy.
This means staying in your home and away from other household members for:

• 10 days since testing positive or
• 10 days after your symptoms first appear and
• At least 24-hours after your symptoms have improved and you've been without fever (without the use of fever-reducing medications)
   

Once this isolation is complete you can return to work, school, or leave your home (but you should continue to wear a mask, physically distance, and wash your hands often).
 

Because there's very limited data regarding how this therapy affects pregnant women and unborn babies, it's important to discuss your treatment options and your specific situation with your doctor.
 

Everyone should be vaccinated against COVID-19 as soon as they are safely able to do so.
 
After receiving monoclonal antibody therapy, it's recommended you wait 90 days before receiving the COVID-19 vaccine. If you received your first dose of a two-dose vaccine before therapy, we recommend you wait 90 days before receiving your second dose.
 

The U.S. government has bought doses of Regeneron’s monoclonal antibodies, which are free to patients who qualify. Depending on your insurance coverage you may be responsible for costs associated with the administration of the therapy.
 

If you are a Northern Light Health patient who has tested positive for COVID-19, your primary care provider or our Care Management team will reach out to you and recommend monoclonal antibody therapy.
 
If you are not an established Northern Light Health patient, or you have a family member who you think may benefit from treatment, you should reach out to your doctor – they can help you access treatment.
 

Monoclonal antibodies are a treatment for mild to moderate COVID-19, the disease caused by the novel coronavirus SARS-CoV-2.

Monoclonal antibodies are just like your body's antibodies but selected for their strong ability to resist the virus. They are produced like a medication and help your body fight illness. In 2020, the Food and Drug Administration issued an emergency use authorization to permit monoclonal antibodies as a treatment option for COVID-19.

Antibodies are proteins made by your body's immune system that fight off infections, including infections caused by viruses. Your body can remember how to make antibodies if you are exposed to the same germ again.

Monoclonal antibodies act just like the antibodies your immune system creates. The first time you are exposed to SARS-CoV-2, it can take up to 7-10 days for your body to create its own antibodies. Monoclonal antibodies help your body fight the infection while your own immune system develops its own defenses.

Data from 5 randomized controlled trials have shown that, in select high-risk patients, monoclonal antibodies can successfully reduce COVID-19 hospitalization rates and your risk of dying from COVID-19. They can also reduce the amount of virus found in an infected person's blood. The monoclonal antibodies are most effective when started early in the infection, within the first 7 days.

Monoclonal antibodies do not provide long-lasting protection against COVID-19. At this time, the CDC recommends receiving COVID-19 vaccine at any time following receipt of antibody therapy.

Monoclonal antibodies stay in your system for up to a month and potentially longer, however vaccines provide the best protection against future infections. Patients who receive monoclonal antibodies should still getvaccinated against COVID-19 and can do so anytime after receipt of monoclonal antibodies.

Not all monoclonal antibodies are equally effective against circulating variants. Yes, available monoclonal antibodies work against currently circulating variants including the delta variant.

As of 06/01/2022, there have been 5 randomized controlled trials published in peer reviewed journals on the use of monoclonal antibodies to treat COVID-19. In these studies, >2,000 patients received the monoclonal antibodies. Overall, over >1,000,000 patients have received monoclonal antibodies in the US.

Our team at Northern Light will work to connect you with an infusion provider near you to ensure that you are scheduled to receive this treatment. Please keep in mind that these appointments are typically not offered same day, but we will make every effort to get you in quickly. These treatments may either be offered in the home or at a nearby healthcare facility depending on resource availability.

As of 06/01/2022, the safety of monoclonal antibodies has been reported in 5 randomized controlled trials. The most common side effects were related the infusion and included flushing, itching, chest tightness, shortness of breath, nausea, vomiting, and rash. Severe side effects such as anaphylaxis (severe allergic reaction) were rare and occurred in <0.1% of patients. In all, only 0.2% of patients required discontinuation of the drug due to side effects. The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to allow monoclonal antibodies as a treatment option for COVID-19. Health officials continue to monitor the safety and effectiveness of the treatments, and clinical trials are ongoing.

Most monoclonal antibodies are administered by infusion. Some monoclonal antibodies may also be administered by intramuscular or subcutaneous injection depending on the type of monoclonal antibody available.

The most common reported side effects for bamlanivimab/etesevimab are:

• Fever
• Difficulty breathing
• Rapid/slow heart rate
• Tiredness
• Weakness
• Confusion

The most common reported side effects for casirivimab/imdevimab are:

• Nausea
• Vomiting
• Hyperglycemia
• Pneumonia

IV infusions can also cause brief pain, bleeding, skin bruising, soreness, swelling, and infection at the infusion site.

Monoclonal antibodies may cause other side effects. Talk to your doctor if you experience any side effect that bothers you or does not go away quickly.

People who have received a monoclonal antibody infusion for COVID-19 are eligible to receive COVID-19 Vaccines anytime after treatment.

If you already received one or both doses of the vaccine and you are eligible, you can receive this treatment.

Check with your insurance provider for more information on the cost of monoclonal antibody treatment for COVID-19.

While pregnant and breastfeeding patients are included in the FDA Emergency Use Authorization, monoclonal antibodies have not been studied in this population. The American Academy of Obstetricians and Gynecologists states that use in this population can be considered, particularly in patients with additional risk factors (such as obesity, diabetes, heart and other chronic diseaess)

While pregnant and breastfeeding patients are included in the FDA Emergency Use Authorization, monoclonal antibodies have not been studied in this population. The American Academy of Obstetricians and Gynecologists states that use in this population can be considered, particularly in patients with additional risk factors (such as obesity, diabetes, heart and other chronic diseaess)