We are experiencing very high demand for monoclonal antibody therapy. We are doing our best to accommodate as many patients as possible, but cannot guarantee treatment for every referred patient. It is important to make patients aware of this when counseling them about the treatment.
BJC is administering a new monoclonal antibody therapy (mAb) for COVID-19 recently granted emergency use authorization (EUA) by the FDA. The monoclonal antibody cocktail is administered through outpatient infusion and is authorized for early treatment of high-risk patients who have mild to moderate COVID-19.
Monoclonal antibodies are investigational and are not FDA-approved for COVID-19.
QUICK LINKS: Inclusion Criteria | Exclusion Criteria | Ordering Treatment | EUA Fact Sheets
Who is eligible?
At BJC, and under the EUA mandatory requirements, monoclonal antibodies are only authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization. These agents are not FDA-approved for these uses.
Patients who with at least one high-risk condition:
- Older age
- Younger than one year old
- Obese or overweight
- Pregnancy (Washington University School of Medicine guidance for treating COVID-positive pregnant patients)
- Chronic kidney disease
- Diabetes
- Immunosuppressive disease or treatment
- Cardiovascular disease or hypertension
- Chronic lung disease
- Sickle cell disease
- Neurodevelopmental disorder or other condition that confers medical complexity
- Medical-related technological dependence
- Part of a group at increased risk of getting sick and dying from COVID-19 due to long-standing systemic health and social inequities, including racial and ethnic minorities and people with disabilities
- Other medical condition and/or factor associated with increased risk for progression to severe COVID
And treatment of COVID-19 infection
- Laboratory-confirmed COVID-19 (rapid antigen or PCR test)
- Able to receive treatment within 10 days of symptom onset
- One or more symptoms consistent with COVID-19 (fever, cough, shortness of breath, fatigue, myalgia, headache, new loss of taste or smell, sore throat, congestion, runny nose, nausea or vomiting, diarrhea)
mAb Exclusion Criteria (if meets any one criterion)
- Hospitalized with COVID-19 (if 2 years of age or older)
- Requiring oxygen therapy due to COVID-19
- Requiring increase in baseline oxygen due to COVID-19 in those on chronic oxygen therapy
Eligible patients should be made aware that the CDC recommends deferring COVID-19 vaccination for at least 90 days after receiving monoclonal antibodies, as a precautionary measure until additional safety and efficacy information becomes available.
COVID-19 testing and treatment
The efficacy of the mAb therapy is dependent on the patient receiving treatment in a timely manner; important factors include duration of symptoms and the inclusion and exclusion criteria. The following algorithms and Tip Sheets will guide you through the process of ordering COVID testing (if needed) and mAb treatment. Providers can order using paper order forms as an alternative to placing orders in Epic.
Talking Points
Please use the document below for talking points to use in counseling and gaining consent from patients for treatment.
Talking points for providers to use with patients who have COVID-19
Order the Treatment
For qualifying patients who receive positive test results, there are two options to order treatment: directly enter into Epic or a fill out and fax a paper order form. Choose one of these below.
Please be aware that with the emergence of variants, ever changing guidelines on monoclonal antibody therapy, and supply constraints, we may need to change the drug administered in our infusion clinics in order to provide the best therapy for our patients. These changes, made based on input from the Washington University Treatment Guidance Group, will need to be dynamic and will be made automatically.
Epic workflow:
Adult Epic HIP TIP for Ordering Treatment Pediatric Epic HIP TIP for Ordering Treatment
Paper form:
Please fill out the forms in their entirety and sign the bottom of the order form. Failure to do so could result in your patient being unable to receive treatment.
Adult Order Form (updated 1/12/2022) Pediatric Order Form (updated 1/12/2022)
ED Providers:
ED providers ordering treatment for patients to receive at outpatient clinics should follow the instructions below.
HIP TIP for ED Providers to Order for mAb Clinics
If we are able to schedule the patient for treatment, an infusion center team member will contact the patient to schedule and provide instructions for the facility where treatment will be administered. If we are unable to schedule the patient due to capacity, the referring physician will receive a message in Epic or via fax and we ask that you communicate with your patient that we are unable to schedule treatment.
For pediatric patients, providers may order monoclonal antibodies directly for any patients who meet EUA criteria. If you have questions or would like to discuss a case, please call St. Louis Children’s Hospital Children’s Direct 800.678.HELP (4357) and ask for the immunocompromised ID provider on call.
Treatment delivery
Monoclonal antibody treatment must be administered by a 30-minute intravenous (IV) infusion, with at least one hour of observation after the infusion is complete. Immediate access to medications to treat severe infusion reactions and the ability to activate the emergency medical system are required.
Locations for treatment
Currently we are offering the treatment at the locations below.
EUA Fact Sheets (sotrovimab)
Download the Fact Sheet for Patients, Parents and Caregivers
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EUA Fact Sheets (casirivimab and imdevimab)
Download the Fact Sheet for Patients, Parents and Caregivers
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EUA Fact Sheets (bamlanivimab and etesevimab)
Download the Fact Sheet for Patients, Parents and Caregivers
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