On November 9 the FDA issued an emergency use authorization to Eli Lilly for an anti-SARS-CoV-2 monoclonal antibody called Bamlanivimab. Preliminary data leading to this authorization suggest this agent can significantly reduce rates of hospitalization amongst patients at high risk for complications of COVID19. It is approved for outpatient use within 10 days of symptom onset and is administered as an IV infusion.
TCHHN has been allocated a small supply and has been working to establish an infusion center which can accommodate COVID19 patients.
Candidates for infusion must meet ALL of the 4 following criteria:
Have a positive result of direct SARS-CoV-2 viral testing
Serologic testing is not adequate to establish diagnosis of active disease
12 years of age or older
Weigh at least 40kg
High risk for for progressing to severe COVID-19 as defined below (must meet ONE of the following criteria):
BMI >=35
Have chronic kidney disease
Have diabetes
Have immunosuppressive disease
Are currently receiving immunosuppressive therapy
Are >=65 years of age
Are >=55 years of age AND have 1 of the following:
Cardiovascular disease
Hypertension
Chronic obstructive pulmonary disease/other chronic respiratory disease
Bamlanivimab is NOT authorized for:
Inpatient use
Patients who require oxygen therapy due to COVID19
Patients on chronic oxygen therapy who require an increase in baseline oxygen flow rate due to COVID19
Referring providers should enter a “Referral to COVID-19 Infusion Center” in EPIC.
The referring provider will be required to counsel the patient according to the FDA’s fact sheet for patients, provide the patient with a copy of this fact sheet and verify that they have done so in the referral.
Attached is the FDA “Fact Sheet for Health Care Providers” & “Fact Sheet for Patients, Parents and Caregivers.”
Please also counsel your patients that they may be contacted by the Lindner Research Center regarding clinical trials of other therapies for COVID-19.
For provider questions, email Infectious Disease physicians John Cafardi, MD (john.cafardi@thechristhospital.com) or Doug Haas, MD (douglas.haas@thechristhospital.com).
Where: The infusion center is located on the ground floor of the Joint & Spine Center
When: Available 7 days a week (including weekends and holidays) while drug is available.
How: We aim to schedule patients for infusion within 24 hours of referral, typically the next day.
**Appointments will begin on Tuesday, November 24, and Infusion Nurses will provide the staffing.
Opening the infusion center required many teams to pull together in a short period of time, among them: Infectious Disease, Pharmacy, Infection Prevention, Finance, Registration, IT, Data Analysts, HTM, Facilities, Grounds, Periop Services, Ambulatory Procedures, Security, OT/PT, EVS, Central Service, Supply Chain, Real Estate, Radiology, and others…a huge thank you to all involved for such great, collaborative efforts!