If you are at risk for serious COVID-19 and you have tested positive for COVID-19 or have been in close contact with someone who has tested positive, you may want to consider a monoclonal antibody (mAb) treatment. You may qualify for this promising COVID-19 treatment depending on your age, health history, and how long you have had symptoms. You do not need to have symptoms or test positive to qualify for mAb treatment if you are at high risk for serious COVID-19.

The mAb treatment can block the SARS-CoV-2 virus (the virus that causes COVID-19) from entering cells in your body and limit the amount of the virus within your body. This means you may have milder symptoms and may decrease the likelihood of you needing to stay in the hospital.

The mAb treatment may help people who:

• Are at high risk of getting more serious symptoms and
• Have a positive COVID-19 test with symptoms for 10 days or less or
• Have been in close contact with someone who has recently tested positive

People who are considered at high risk may develop more serious symptoms of COVID-19. Serious symptoms may cause a person with COVID-19 to go to the hospital, be admitted into intensive care, need help breathing, and have a greater risk of death. Being at high risk depends on your health history and how long you have had COVID-19 symptoms.

If you are at high risk for COVID-19, you may qualify for:

• Treatment before you come into contact with someone who may have COVID-19 (this treatment is known as pre-exposure prophylaxis or PrEP)
• Treatment if you test positive for COVID-19 to help reduce the seriousness of your symptoms

What makes someone at a higher risk for more serious symptoms of COVID-19?

People can be at high risk for many reasons. Some of the most common reasons are:

• 65 years or older
• Cancer
• Cerebrovascular disease
• Chronic kidney disease*
• Chronic lung diseases*
• Chronic liver diseases*
• Cystic fibrosis
• Diabetes mellitus, type 1 and type 2*
• Disabilities*
• Heart conditions (such as heart failure, coronary artery disease, or cardiomyopathies)
• HIV (human immunodeficiency virus)

• Immunocompromised condition or weakened immune system
• Mental health disorders*
• Neurologic conditions limited to dementia
• Obesity (BMI ≥30 kg/m²)*
• Primary Immunodeficiencies
• Pregnancy and recent pregnancy
• Physical inactivity
• Smoking, current and former
• Solid organ or hematopoietic cell transplantation
• Tuberculosis
• Use of corticosteroids or other immunosuppressive medications

*Please see the CDC's list of current medical conditions associated with more severe COVID-19

What treatments and therapies are available?

There are two main types of treatments available for people at risk who are not in the hospital: antiviral medications and mAbs (infusions). The U.S. Food and Drug Administration (FDA) has granted each of these treatments Emergency Use Authorization (EUA) during the COVID-19 pandemic.

PrEP treatment for people who are not exposed: The mAb Evusheld^™ is available for adults and children 12 years or older who:

• Weigh at least 88 pounds
• Do not have a current COVID-19 infection
• Have not been recently exposed to someone who has COVID-19

This prescription treatment is given as a series of shots for people who may be at high risk for serious symptoms of COVID-19. Evusheld is not a substitute for vaccination against COVID-19 and is intended for people who may not have developed a response to the vaccine because of their immune system.

For mild to moderate COVID-19: Treatments for people who are not staying in the hospital include two oral antivirals (Paxlovid^™ and Lagevrio), an intravenous antiviral medication (Veklury^®), and a mAb (bebtelovimab). These treatments could help your immune system respond more effectively to SARS-CoV-2 (the virus that causes COVID-19), reducing the chances that your symptoms will get worse.

The oral antivirals must be taken within the first 5 days COVID-19 symptoms appear. Lagevrio (molnupiravir) is for people ages 18 and older. Paxlovid is for people ages 12 and older who weigh at least 88 pounds. Veklury (remdesivir) should be taken within the first 7 days COVID-19 symptoms appear. Bebtelovimab should be taken within the first 7 days of when COVID-19 symptoms first appear.

Veklury is a treatment for eligible adults and children in the hospital as well as those who are not in the hospital.

The use of the mAb treatments sotrovimab, bamlanivimab/etesevimab, and REGEN-COV^® (casirivimab plus imdevimab) has been paused because the Omicron variants have proven resistant to these treatments.

For people in the hospital with serious COVID-19: Treatments include the mAb tocilizumab (also called Actemra^®), drugs (Veklury/remdesivir, baricitinib, dexamethasone, and corticosteroids), and convalescent plasma.

Your healthcare professional can help you decide if you are eligible for any of the above treatments.

I am at high risk. How can I get a treatment?

If you qualify for PrEP treatment, you do not need a positive COVID-19 test. If you do have mild to moderate symptoms of COVID-19, you will need to have a positive COVID-19 test and you must have had your first symptoms within the past 5 days (for oral antivirals) or 7 days (for Veklury/remdesivir or bebtelovimab).

Your body naturally makes antibodies to fight infection. However, your body may not have antibodies designed to recognize a novel (or new) virus like SARS-CoV-2, the virus that causes COVID-19. Monoclonal antibodies, or mAbs, are made in a laboratory to fight a particular infection (in this case, SARS-CoV-2) and are given to you directly in an infusion. So the mAb treatment may help if you are at high risk for serious symptoms or a hospital stay.

A mAb treatment for COVID-19 is different from a COVID-19 vaccine. The vaccine triggers your body’s natural immune response, but this can take weeks to develop enough antibodies against a virus. So if you have the virus, the mAb treatment gives your body the antibodies it needs to protect itself. The mAb treatment does not replace the need for the immunity from the vaccine but it can help you if you are at risk for developing serious COVID-19.

If you have had symptoms or tested positive for 10 days or less or have been in close contact with someone who has recently tested positive, you should be referred for treatment by your healthcare professional and directed to available infusion locations. If you do not have a healthcare provider, call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585 to find out who to talk with about your symptoms and treatment.

Your healthcare professional may decide you do not qualify for mAb treatment. There could be several reasons for this. You may not meet all eligibility criteria or you may have an underlying health condition that disqualifies you for mAb treatment.

Whatever the reason is, do not give up. There could be another option. You may be be eligible to receive a different treatment or join a clinical trial for COVID-19.

Participants in these clinical trials may receive new medicines or other treatments, so researchers can test how well the treatments work. Thousands of participants in clinical trials have helped with the discovery of new treatments for COVID-19. But many more participants are needed to make sure that treatments work for people of all ages, genders, races, and ethnicities.

Ask your healthcare professional if you may be eligible for a clinical trial for COVID-19 treatments

The mAb treatment is usually offered at an infusion center because the treatment is given through an intravenous (IV) infusion or shots. Depending on the mAb treatment you receive, the whole process takes about 2 to 3 hours. First, the medical staff conduct a screening; then they start an IV, which delivers the mAbs to your body in just over an hour. It takes less time if the mAb treatment is offered to you as a series of shots. Afterward, the medical team will have you stay at the infusion center for another hour to be sure you do not have an allergic reaction or any other side effects. These reactions are rare, but the medical team must observe you for this hour and can respond quickly if you have a reaction. You will be released to go home after the medical team has monitored you following your infusion.

Even if you start feeling better, it is important to know that you could still spread the virus for a while. So, you will need to isolate yourself (be alone) until all of these things happen:

1. At least 10 days have passed since your first symptoms of COVID-19
2. You have not had a fever in at least 24 hours, without taking any medicine that reduces fever
3. Your other symptoms of COVID-19 are improving

IMPORTANT: Follow your healthcare professional’s instructions. Depending on your personal health history, you may need to meet other conditions. Also, if you start to feel worse, do not hesitate to seek medical care.

Antibody treatments do not contain any live SARS-CoV-2, so there is no risk you will get COVID-19 from mAb treatment. However, the antibody treatment may have side effects:

• Allergic reactions can happen during and after an antibody infusion. Tell your healthcare professional right away if you get any of the following signs and symptoms of an allergic reaction: fever, chills, nausea, headache, shortness of breath, low or high blood pressure, rapid or slow heart rate, chest discomfort or pain, weakness, confusion, feeling tired, wheezing, swelling of your lips, face, or throat, rash including hives, itching, muscle aches, feeling faint, dizziness, and sweating.
• An infusion of any medicine may cause brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

These are not all the possible side effects of antibody treatment. Serious and unexpected side effects may happen. Some possible risks from antibody treatment are:

• It may interfere with your body's ability to fight off a future infection of SARS-CoV-2.
• It may reduce your body’s immune response to a vaccine for SARS-CoV-2.

The mAb treatments for COVID-19, like other treatments authorized for emergency use by the U.S. Food and Drug Administration, are still being studied. So it is possible that we do not know all the risks yet. As researchers continue to study the virus and how mAb treatment affects it, we will learn more about these possible risks. If you have any questions, please talk with your healthcare professional.

What are monoclonal antibodies (mAbs)?

Our bodies naturally make antibodies to fight infection. mAbs are made in a lab and given to people directly through an intravenous (IV) infusion.

How do mAbs help people with COVID-19?

mAb treatments authorized by the U.S. Food and Drug Administration (FDA) for emergency use may help people who are at high risk for serious symptoms of the disease to:

a) Reduce the likelihood of staying in the hospital.

b) Recover faster from COVID-19.

Who can receive mAb treatment?

mAbs are available for people who:

1. Are at high risk of becoming seriously ill.
2. Have tested positive for COVID-19 and have mild to moderate symptoms of the disease for 10 days or less
3. Have been recently exposed to someone who has tested positive for COVID-19 and are at high risk for serious COVID-19

How soon does someone need to receive mAb treatment?

mAb treatment must be given within 10 days of a person’s first symptoms of COVID-19. The sooner a person receives mAb treatment, the better.

Are mAb treatments safe?

mAb treatments are still being studied. However, they have received Emergency Use Authorization (EUA) from the FDA and more than 600,000 people have been treated with mAbs. Researchers continue to study mAb treatments for safety and effectiveness.

What are the mAb treatments, and how are they given?

Three mAb treatments have received EUA from the FDA for people who are not in the hospital: REGEN-COVTM (casirivimab and imdevimab), bamlanivimab and etesevimab, and sotrovimab. All treatments are given as either an IV infusion or a series of shots.

Actemra is also a mAb that has also been issued an EUA from the FDA. It can only be given to people in the hospital with worse COVID-19 symptoms.

Are the treatments very different from one another?

The three treatments offered to people who are not in the hospital are designed in a very similar way, with the same goal: to prevent the virus that causes COVID-19 from entering human cells.

Where are mAb treatments offered?

The treatments are offered at thousands of infusion locations across the United States. These include infusion centers, urgent care clinics, and emergency rooms.

Different infusion locations have different amounts of the treatments and staff to give it available, so some locations may not be administering mAb treatments or may have limited stock of them. Your healthcare professional can help you find a location near you and can contact the infusion location to refer you for treatment.

If I think I may qualify for these treatments, what should I do next?

If you think you may qualify for mAb treatments and want to ask about getting treatment, contact your healthcare professional or call 1-877-332-6585 (English) and 1-877-366-0310 (Spanish) for more information.

If I don’t qualify for mAb treatments but want to help, what can I do?

Your healthcare professional may decide you do not qualify for mAb treatment. There could be several reasons for this. You may not meet all of the eligibility criteria or you may have an underlying health condition that disqualifies you for mAb treatment.

Whatever the reason is, do not give up. There may be other treatment options or you may be able to join a clinical trial for COVID-19.

Participants in clinical trials may receive new drugs or other treatments so researchers can evaluate how well the treatments work. Thousands of participants in clinical trials have helped with the discovery of new treatments for COVID-19. Many more participants are needed to ensure that treatments work for people of all ages, genders, races, and ethnicities.

Ask your healthcare professional if you may be eligible for a clinical trial for treating COVID-19.