Monoclonal Antibody Treatment
This treatment is for persons who have tested positive for COVID-19 or for persons who have been exposed to an individual with COVID-19 consistent with the CDC close contact criteria.
A doctor order is required, as well as meeting additional specific criteria.
At Bryan, this is an outpatient treatment using Regeneron – Casirivimab-Imdevimab (REGEN-COV).
Who can receive REGEN-COV?
REGEN-COV has FDA Emergency Use Authorization for adults and children age 12 and older who weigh at least 88 pounds and who are at a high risk for progression to severe disease.
Monoclonal antibodies can be ordered for:
Treatment of mild to moderate COVID-19
This treatment is done to reduce the amount of virus in your body once you’ve become sick and prevent you from becoming very sick, including reducing the chance of hospitalization.
Patients must meet these criteria:
- A positive PCR or antigen test
- Symptoms began in the last 10 days
- At high risk for progressing to severe COVID-19 and/or hospitalization (see FAQs)
Post-exposure prophylaxis (PEP)
This treatment is done to prevent you from acquiring COVID-19 before you become sick or test positive.
Patients must meet these criteria:
- Unvaccinated OR Not fully vaccinated OR Vaccinated but unlikely to mount an adequate immune response (e.g., taking immunosuppressive drugs or have an immunocompromised condition, including hemodialysis)
- Have been exposed to COVID-19 positive individual(s) consistent with CDC close contact criteria, OR is at high risk of an exposure due to a current outbreak in the same institutional setting (i.e., nursing home)
- Are at high risk for progressing to severe COVID-19 and/or hospitalization (see FAQs)
What to do if you feel you qualify for this treatment?
Contact your primary care provider. If you don’t have a primary care provider, go to an urgent care. Bryan has 3 urgent care locations. A provider will determine if this treatment could benefit you. A provider order is needed for treatment.
Frequently Asked Questions
Learn More About Treatment
What is the difference between a monoclonal antibody treatment and a COVID-19 vaccine?
Vaccines are used to prevent COVID-19 infection. One of the main ways they work is by stimulating the body’s immune system to produce antibodies, which identify and eliminate viruses like SARS-coV-2 (COVID-19). ‘Mono’ means ‘one’ and ‘clonal’ means copy. Monoclonal antibodies are made in the laboratory and are a copy of a single highly effective antibody that the body makes naturally after infection. Monoclonal antibodies are a more pure and potent version of the natural antibodies found in plasma after an infection has occurred. This is known as “convalescent plasma”. For monoclonal antibody infusions, only the most effective antibodies are isolated and used.
What is REGEN-COV?
REGEN-COV (casirivimab/imdevimab) is a combination monoclonal antibody (mAb) product for the treatment or prevention of COVID-19. Bryan Medical Center is only administering REGEN-COV at this time. REGEN-COV has been authorized by the FDA under Emergency Use Authorization (EUA) for two indications (while other mAbs can only be used for one indication). Bryan is offering REGEN-COV because it is effective against major COVID-19 variants.
Are there side effects of REGEN-COV?
Yes, some treatment-related side effects are possible. An infusion of any medicine may cause brief discomfort, bleeding, bruising of the skin, soreness, swelling, fever, chills, tiredness, nausea, headache and possible infection at the infusion site. Hypersensitivity and allergic reactions may happen during and after an antibody infusion. Trained health care staff will monitor you for allergic reactions. While side effects are possible, antibody treatments do not contain any live virus. There is no risk that you will get COVID-19 from monoclonal antibody treatments.
Treatment Criteria Details
What patients are considered high risk of progressing to severe COVID-19 and/or hospitalization?
If you have any of the following conditions or risk factors, you may at increased risk for severe COVID-19 disease:
- Older age (for example, age 65 or older)
- Obesity or being overweight (for example, adults with BMI >25 kg/m2, or if age 12-17 AND have BMI ≥85th percentile for their age and gender based on CDC growth charts)
- Chronic kidney disease
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease (including congenital heart disease) or hypertension
- Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
- Sickle cell disease
- Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
- Having a medical-related technological dependence (for example, tracheostomy, gastrostomy or positive pressure ventilation [not related to COVID-19])
Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19, and authorization of REGEN-COV under the EUA is not limited to the medical conditions or factors listed above. For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the CDC website: People with Certain Medical Conditions. Health care providers should consider the benefit-risk for an individual patient.
What is the definition of fully vaccinated?
The CDC considers that individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series (such as the Pfizer or Moderna vaccines), or 2 weeks after a single-dose vaccine (such as Johnson & Johnson’s Janssen vaccine).
What is the definition of the CDC close contact criteria?
The CDC considers it to be close contact if you were within 6 feet of an unmasked infected person (either 2 days before symptoms begin or 2 days before a positive test if you don’t have symptoms) for a cumulative time of 15 minutes or more within 24 hours.
Are there people who should not receive REGEN-COV?
You are NOT eligible to receive REGEN-COV if you:
- Are hospitalized due to COVID-19, OR
- Require oxygen therapy due to COVID-19, OR
- Require an increase in baseline oxygen flow rate due to COVID-19 (for those on chronic oxygen therapy due to an underlying non-COVID-19 related health issue)
Can I receive this treatment if I'm pregnant or breastfeeding?
- There are insufficient data for the use of REGEN-COV in pregnancy to evaluate drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
- There are no available data on the presence of REGEN-COV in human or animal milk, the effects on the breastfed infant, the effects on milk production, or on possible health effects from breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for REGEN-COV and any potential adverse effects on the breastfed child from REGEN-COV or from the underlying maternal condition.
- REGEN-COV should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.
- Discuss your options with your health care provider or your baby’s provider.
Treatment Questions Related to COVID-19 Vaccine
I recently received a COVID-19 vaccine but still developed COVID-19 infection. Do I still qualify for REGEN-COV treatment?
Yes, you may still receive REGEN-COV treatment if you meet the criteria.
I am planning to get the COVID-19 vaccine soon. Can I still get the vaccine if I receive monoclonal antibody treatment including REGEN-COV?
- Monoclonal antibodies are an example of “passive immunity”, because they are being given as a treatment, whereas vaccines stimulate “natural immunity”, where your body makes these antibodies before you become sick.
- Monoclonal antibodies are NOT a substitute for vaccination against COVID-19. The vaccines provide effective and longer lasting protection against COVID-19.
- Persons who receive monoclonal antibodies for COVID-19 treatment should wait 90 days after the monoclonal antibody infusion before receiving a COVID-19 vaccine. Click on the link below for further details:https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf
Preparing for Treatment
What can I expect after my doctor orders this treatment?
You will receive a call from the Bryan Scheduling Center and Patient Service Center with the following information:
- Appointment date/time and what to bring
- Where to park – Professional Office Building Parking Lot at 2221 S. 17th St. in a reserved space; call from vehicle; staff will meet and escort patient to the treatment area at Bryan West Campus
How can I prepare for REGEN-COV infusion treatment? Where do I go?
- Get plenty of rest the night before and drink plenty of water
- Continue to take your daily medications as you normally would
- Eat a light meal/snack before coming
- Wear warm, comfortable clothes with a shirt that can roll-up over the elbow
- Consider bringing some activity to help pass the time, as there is a 1 hour observation period once the infusion has ended to make sure you tolerate the REGEN-COV; your entire appointment time will be about 2 1/2 hours
- Only those with a treatment appointment may enter the hospital
- If patient is a minor, one parent/guardian may attend
- Unless you have a family member receiving treatment at the same time, you should arrive alone
- If you are being dropped off, your driver should stay with you until our staff meet you; we will have you call your driver 15 minutes before they should return to pick you up
- Please use the restroom before you arrive; restroom space in this treatment area is very limited
- Masks/face coverings are required from the time you leave your vehicle to the time you return to your vehicle
Additional information for your arrival:
- Bring your cell phone so you can call us from your vehicle when you arrive
- Arrive no more than 15 minutes before your scheduled appointment time
- Park in the Bryan West Campus Professional Office Building Lot at 2221 S. 17th St.
- When you enter the parking lot, turn right. Park in stalls identified at RESERVED PARKING. Remain in your vehicle and call the number on the Reserved Parking sign. You will need to provide your name, parking stall number, and the make, model and color of your vehicle (see map below)
- A staff member will meet you at your vehicle to take you to the clinic. Please remain in your vehicle while you wait
How is REGEN-COV infusion given?
An infusion is administered into a vein in your arm. This must be done by skilled professionals; therefore, it can only be administered in health care facilities. Only a single dose of REGEN-COV is required. You will be watched closely while you receive this medication and for some time after your infusion is completed. If infusion through the vein is not possible, you may be able to receive REGEN-COV through multiple injections into fat tissue in your arm or thigh.
Will I have to sign a special consent form to receive REGEN-COV?
No. If your health care provider determines that you meet the EUA criteria for REGEN-COV, you can receive REGEN-COV without signing a consent form. Your health care provider will:
- Discuss the risks/benefits and inform you of alternatives to receiving authorized REGEN-COV, and
- Discuss that REGEN-COV is an unapproved drug that is authorized for use under this Emergency Use Authorization (EUA), and
- Give you the REGEN-COV EUA Fact sheet for Patients and Caregivers to read and make an informed decision
If I receive monoclonal antibodies, do I still need to isolate if I have COVID-19 or quarantine if I've been exposed to COVID-19?
Yes. You must still follow the same isolation and quarantine requirements to protect yourself and others. Receiving REGEN-COV will not reduce the duration of your isolation or quarantine.
When should my COVID-19 symptoms resolve after I receive REGEN-COV?
It depends on how your body responds to the treatment. Most patients see an improvement in symptoms between 24 to 72 hours after a monoclonal antibody treatment.
What if I get worse despite receiving this medication?
Patients do not always respond in the same manner to the same treatment. Worsening of COVID-19 has happened after the use of REGEN-COV and is more likely the later you receive REGEN-COV after symptom onset. Symptoms may include fever, trouble breathing, fast or slow heartbeat, or feeling confused, tired, or weak. If you experience these symptoms, seek medical attention as soon as possible.
What is the cost of REGEN-COV treatment?
The REGEN-COV medication is provided at no charge by the federal government so you are not charged for the medication. There is a charge to administer the medication. The administration fee will be charged to your insurance or to Health Resources & Services Administration (HRSA) if you don’t have insurance.