What is monoclonal antibody treatment?

When you get infected with a virus, such as severe acute respiratory syndrome coronavirus 2 (SARS­CoV-2), the virus that causes COVID-19, your immune system creates antibodies to fight it off. It takes time for your body to make these antibodies, which allows the infection to get worse and make you sicker. Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as viruses. 

The St. Charles Pulmonary Clinic uses REGEN-COV as its chosen brand of monoclonal antibody treatment. REGEN-COV contains two monoclonal antibodies that neutralize SARS-CoV-2 to help patients fight and recover from COVID-19. Being treated with REGEN-COV antibodies as soon as you are diagnosed with COVID-19 may limit the amount of virus that develops in your body, which may help you recover from the infection. 

How can a patient schedule an appointment?

Patients cannot self-refer for this treatment. Please consult with your primary care provider regarding possible risk factors and potential treatment.

Physicians: To refer your patient for this treatment, please download, print and complete the mAb Outpatient Treatment Order Form and fax it to our St. Charles Pulmonary Clinic at 541-598-3492. Please also call the Pulmonary Clinic at 541-706-7715 to alert the staff to the incoming fax. Monoclonal Antibody Treatment must be infused within 10 days of symptom onset. Turnaround time for infusion administration is generally three days from the date of the referral being placed, so please submit your order as soon as possible.

mAb Emergency Use Authorization

Monoclonal Antibody Treatment has not been approved, but has been authorized for emergency use by the FDA. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

FDA Letter of Authorization

Who is eligible for monoclonal antibody treatment?

Eligible patients can receive this treatment if they exhibit mild to moderate symptoms of COVID-19, NOT hospitalized and are the following: 

  • at least 12 years old (St. Charles is requiring the patient be at least 14 years old) AND
  • at least 88 pounds (40kg) AND
  • at high risk of developing severe COVID-19 symptoms or the need for hospitalization

Who would be considered "high risk" for developing severe COVID-19 symptoms?

You should speak to your health care provider about your risk factors. Here are a few risk factors that might make you eligible for the mAb treatment:

  • Have a body mass index (BMI) greater than or equal to 35
  • Have chronic kidney disease
  • Have diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Are 65 years of age or older
  • Are 55 years of age or older AND have
    • cardiovascular disease, OR
    • hypertension, OR
    • chronic obstructive pulmonary disease/other chronic respiratory disease
  • Are 14-17 years of age AND have
    • a BMI greater than or equal to the 85th percentile for their age and gender based on CDC growth charts, OR
    • sickle cell disease, OR
    • congenital or acquired heart disease, OR
    • neurodevelopmental disorders, for example cerebral palsy, OR
    • a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
    • asthma, reactive airway or other chronic respiratory disease that requires daily medication for control

Where do patients receive the treatment?

We are currently only offering this treatment in our St. Charles Redmond hospital. 

What should the patient expect?

The infusion treatment visit will last approximately 2-3 hours. Visitors are not allowed in the infusion area. Upon arrival, a caregiver will obtain the patient's vital signs and notify the pharmacy. The actual infusion take approximately 60 minutes. After the infusion, the patient is observed by medical personnel for one hour. 

Does the patient have to wear a mask?

All patients entering a St. Charles facility must wear a mask to their appointment, regardless of vaccination status. The patient will be provided a hospital-issued mask to wear for the duration of their appointment.