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 the following:
- Early treatment of high-risk patients who have mild to moderate COVID-19
- Prophylaxis for high-risk patients who have been in close contact with a COVID-positive individual
Monoclonal antibodies are investigational and are not FDA-approved for COVID-19.
QUICK LINKS: Inclusion Criteria | Exclusion Criteria | Ordering Testing | Ordering Treatment
Who is eligible?
At BJC, and under the EUA mandatory requirements, monoclonal antibodies are only authorized for patients who meet the below criteria.
Patients with at least one of the high-risk conditions below AND who meet the criteria for either treatment or prophylaxis as outlined in the table below:
Patients who with at least one high-risk condition:
- Older age
- Obese or overweight
- Pregnancy (for help with counseling pregnant or breastfeeding patients, MFM patient consultation can be arranged by calling 314.362.0004)
- Chronic kidney disease
- 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)
OR Post-exposure prophylaxis against COVID-19 infection
- Not fully vaccinated* or not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (e.g., immunosuppressed/compromised)
- Close contact with a COVID-positive person as defined by the CDC** or at high risk of exposure due to an outbreak in an institutional setting
- Able to receive treatment within 7 days of exposure
* 2 weeks after 2nd dose of Pfizer or Moderna, or 2 weeks after J&J
** CDC defines close contact as someone who has been within 6 feet of an infected person for a cumulative total of 15 minutes or more over a 24-hr period
mAb Exclusion Criteria (if meets any one criterion)
- Less than 12 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
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/time since exposure, 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.
Order the COVID-19 test for symptomatic patients
(if they don’t already have a positive test)
It is important that a rapid COVID-19 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 to order the COVID-19 test.
Non-Epic providers can order the COVID-19 test however desired. In order to have the test collected at a BJC Specimen Collection Site, please use this form and fax to our central team.
For tests collected outside of BJC, please fax the positive Antigen or PCR test with the order form for treatment.
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
Talking points for providers
to use with patients for prophylaxis against 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.
Adult Epic HIP TIP for Ordering Treatment Pediatric Epic HIP TIP for Ordering Treatment
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 Sheet and Attestation Pediatric Order Sheet and Attestation
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.
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.