Monoclonal Antibody Treatment

What are Monoclonal Antibodies?

Monoclonal Antibodies (mAbs) are antibodies made in a lab that target specific viruses and diseases.  The COVID-19 mAbs are designed to target the spike protein of the coronavirus.  When the antibodies bind to the virus, they prevent them from entering the body’s cells.  If the virus can’t enter the cells, it can’t continue to grow and survive.

While there is more than one mAb, Wise Health System is currently administering casirivimab/imdevimab (Regen-CoV).  This product is very effective for the COVID-19 strain in our region, reducing hospitalization and death of high-risk patients infected with SARS-CoV-2 by about 70% and 81% at preventing symptomatic COVID-19 when high-risk patients are exposed to COVID-19.

When COVID-19 mAbs are given to a patient who is already sick, they help prevent the patient from developing severe symptoms that could require hospitalization. 

When COVID-19 mAbs are given to high-risk patients who have been exposed to COVID-19, they fight the virus to prevent the patient from becoming sick. 

When should you get COVID-19 mAb treatment? 

COVID-19 mAbs work best when they are given early, within the first 4-5 days is best.  As you approach the 10 day mark, the COVID-19 mAbs are not effective and may make a patient worse.

Who are the COVID-19 mAb therapies for?

In order to be a candidate for this therapy, all the following criteria must be met:

1. Patient has a positive SARS-CoV-2 test
2. Patient is NOT sick enough to require hospitalization.
3. Patient is NOT sick enough to require an increase in baseline oxygen therapy or additional oxygen supplementation.
4. Patient’s first symptom was less than 10 days ago.
5. Must fall into 1 of the 2 categories below:
   • 65 years and older or
   • 12 -64 years of age weighing at least 88 pounds AND have a high-risk condition
     • Cardiovascular disease
     • High blood pressure
     • COPD or other respiratory disease
     • Chronic kidney disease
     • Diabetes
     • Immunosuppressive disease or Immunosuppressive treatment
     • Overweight (ex:  BMI over 25 or over 85th percentile on growth chart)
     • Pregnant
     • Sickle cell disease or thalassemia
     • Neurodevelopmental or neurologic disorders
     • Medical-related technological dependence (ex:  tracheostomy or gastrostomy)
     • Other medical conditions (ex:  history of cancer, dementia, Down syndrome, liver disease, current smoker, history of smoking, history of stroke, substance abuse, racial or ethnic minority, other disability)

ALTERNATIVELY, the COVID-19 mAb antibody therapy can be given after high-risk patients have been in close contact (15 minutes or longer within 6 feet) of an infected person.  Criteria for this treatment includes number 2, 3, and 5 above.

Who should not receive the COVID-19 mAb therapies?

1. Patients sick enough to be admitted to the hospital
2. Anyone under the age of 12
3. Patients between 12 and 64 who do not have at least one of the listed high-risk conditions
4. Patients having a hypersensitivity to any ingredient of the mAb treatment

What if I was vaccinated for SARS-CoV-2?

Vaccination does not make you ineligible for this therapy.  However, vaccinated patients have a lower risk of getting COVID-19 when exposed and for developing severe disease if they do become infected.  In some cases, a vaccinated person may be a good candidate for this therapy, such as being immunocompromised or becoming infected with COVID-19 and getting significant symptoms.  These cases should be discussed with your healthcare provider to determine your risk. 

What should I expect on infusion day?

Once you arrive for your scheduled appointment you will check in at the ER admissions location.  Documents will be reviewed from the prescribing practitioner and all necessary forms must be completed prior to therapy.  This includes signed criteria for use, consent, medication orders, and acknowledgement of the FDA Emergency Use Authorization.  The entire infusion process will take approximately 3-4 hours from the time of arrival until the time of discharge.

What are possible side effects of this treatment?

During the clinical trials, infusion related reactions have occurred in 0.2% of patients (itching, flushing, fever, shortness of breath, chest pain, nausea, vomiting, or rash).  Allergic reactions may occur.  Worsening of COVID-19 may occur after administration, sometimes requiring hospitalization.  It is not known if this is due to worsening of disease or the use of REGEN-CoV.  Worsening is more likely to occur when given to patients who were hospitalized with COVID-19, required more oxygen than normal, and who had symptoms more than 10 days.  This information was used to develop the criteria for use.

If I’ve had Monoclonal Antibody Treatment, should I get the COVID-19 Vaccine?

Patients who receive Monoclonal Antibody Treatment should wait at least 90 days before receiving the COVID-19 vaccine.

---

Click below to download a PDF containing frequently asked questions about the Monoclonal Antibody Treatment.

Download PDF