Monoclonal Antibody Therapy to Treat COVID-19

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 indicated for high-risk outpatients who are early in their symptom presentation and not receiving oxygen related to their COVID-19 diagnosis. Monoclonal antibodies are investigational and are not FDA-approved for COVID-19.

Who is eligible

At BJC, and under the EUA mandatory requirements, monoclonal antibodies are only authorized for patients who meet the below criteria.

Fact Sheet for Healthcare Providers and full EUA requirements

mAb Inclusion Criteria (must meet all criteria)

Laboratory-confirmed COVID-19 (rapid antigen or PCR)
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)
Has at least one of the following high-risk conditions
- Body mass index (BMI) of ≥ 35
- Chronic kidney disease
- Diabetes
- Immunosuppressive disease
- Currently receiving immunosuppressive treatment
- ≥ 65 years of age
- Age 55 to 64 years PLUS one of the following
  - Cardiovascular disease
  - Hypertension
  - COPD/other chronic respiratory disease

mAb Exclusion Criteria (if meets any 1 criterion)

Asymptomatic
Less than 18 yrs of age
Less than 40 kg
Hospitalized due to COVID-19
Requiring oxygen therapy due to COVID-19
Requiring increase in baseline oxygen due to COVID-19 in those on chronic oxygen therapy

Benefit of treatment with monoclonal antibodies has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

There is insufficient data to guide therapy in pregnant and breastfeeding patients, but treatment in these patients may be considered if potential benefit outweighs risk. If you would like help counseling your pregnant patients, MFM patient consultation can be arranged by calling (314) 362-0004.

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.

Algorithm for ordering COVID testing and/or treatment

The efficacy of the mAb therapy is dependent on the patient receiving treatment in a timely manner; important factors include length of symptoms, if patient already has a positive COVID result or needs testing first, and the inclusion and exclusion criteria. The following algorithm will guide you through the process of ordering COVID testing and/or mAb treatment. Please review the algorithm carefully for each patient.

View the criteria algorithm.

How to order the test and treatment

Providers can use either EPIC or the paper forms to order testing and treatment. Follow the instructions below. Please note that we are expanding the treatment to include pregnant and breastfeeding patients who otherwise meet the criteria and have received counseling. Details of arranging this counseling are in the Tipsheets.

Order the Test:

It is important that a COVID-19 antigen or PCR test is ordered for results to be received in time for the patient to be eligible to receive this treatment.

In Epic, please follow the instructions in the hip tip below to order the antigen test.

Epic HIP TIP for ordering the antigen test

Non-Epic providers can order the COVID-19 Antigen however desired. In order to have the test collected at a BJC Specimen Collection Site, please use the form below and fax to our central team.

BJC Specimen Collection Site Antigen Test Form

For tests collected outside of BJC, please fax the positive Antigen or PCR test with the order form for treatment (below).

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

For qualifying patients who receive a positive test results, follow the instructions below for ordering mAb therapy.

Order the treatment:

For qualifying patients who receive positive test results, there are two options to order treatment: paper option to be faxed or electronic option through Epic. There are different forms and tip sheets because the Missouri infusion clinics are on Epic and the Illinois infusion clinics are on Meditech. Please follow the instructions based on the location where the patient wants to receive treatment.

Epic workflow:

Epic HIP TIP for Ordering Treatment in Missouri (BJH/CH) Epic HIP TIP for Ordering Treatment in Illinois (MHB)

Paper forms:

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.

Order Sheet and Attestation for Missouri (BJH/CH) Order Sheet and Attestation for Illinois (MHB)

Once the order is placed, an infusion center team member will contact the patient to schedule treatment and will provide details on monoclonal antibody treatment and instructions for the facility where treatment will be administered.

Reporting Adverse Reactions After Treatment

The prescribing health care provider and/or the provider’s designee are/is responsible for mandatory reporting of all medication errors and serious adverse events potentially related to mAb treatment within 7 calendar days from the onset of the event.

Serious Adverse Events are defined as:

death;
a life-threatening adverse event;
inpatient hospitalization or prolongation of existing hospitalization;
a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
a congenital anomaly/birth defect;
a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly.

Submit adverse event reports to BJC and FDA MedWatch:

Contact the BJC Infusion Center where the patient received treatment:
Submit to FDA MedWatch through one of the options below:
- Complete and submit the report online: www.fda.gov/medwatch/report.htm,
- MedWatch: FDA Safety Information & Adverse Event Reporting Program - reporting on prescription/OTC medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human drug.

Treatment delivery

Monoclonal antibody treatment must be administered by a one-hour 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. All sites are open 9 a.m. to 5 p.m. Monday through Friday and the Barnes-Jewish Hospital site is also open from 2-6 p.m. on Saturdays.

Memorial Hospital Belleville
Medical Office Center – One/Entrance A
4550 Memorial Drive
Belleville, Illinois 62226
618-257-4797

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