Body

What is monoclonal antibody therapy?

Monoclonal antibodies mimic the immune system’s ability to fight back against harmful antigens such as viruses. Whereas the body takes time to produce natural antibodies, monoclonal antibodies allow a sick person to fight the virus earlier, which may prevent them from getting sicker and needing to be hospitalized.

Monoclonal antibodies have Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). REGEN-COV is the name of the therapy used by St. Charles Health System.

Is it safe?

The issuance of an EUA is different than FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of available evidence and carefully balances known or potential risks with known or potential benefits of the product for use during an emergency. Based on that review, the FDA determined it is reasonable to believe the treatment may be effective in treating adults and certain pediatric patients with mild to moderate COVID-19 and issued an EUA.

Who is it for?

Monoclonal antibody therapy is for COVID-positive people at high risk for becoming severely ill because they are not fully vaccinated or not expected to mount an adequate immune response to full vaccination. The following conditions may be an indicator of eligibility:

  • Age 65 and older
  • Obesity or being overweight
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or immunosuppressive treatment
  • Cardiovascular disease or hypertension
  • Chronic lung diseases
  • Sickle cell disease
  • Neurodevelopmental disorders
  • Other medical conditions or factors (for example, race or ethnicity) that may also place individual patients at high risk for progression to severe COVID-19 and authorization. Your provider will work with patients on a case-by-case basis to consider the benefits and risks for an individual.

Who is not eligible for monoclonal antibody therapy?

  • People hospitalized for COVID-19
  • People who require oxygen therapy due to COVID-19, or
  • People on chronic oxygen therapy due to an underlying non-COVID-19-related comorbidity and who require an increase in oxygen flow rate from baseline because of COVID-19

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.

Providers: To refer your patient for this treatment, please complete the mAb Outpatient Treatment Order Form electronically or enter the order using EpicCare Link. You can also call the mAb Clinic at (541) 706-4090 to place the order. 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

Where do patients receive the treatment?

We are currently offering this treatment in our Bend East Family Care Clinic at 2600 NE Neff Road and in our St. Charles Redmond and St. Charles Prineville hospitals. 

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.