Home / Health Care Professionals / COVID-19 Outpatient Therapeutics - Health Care Professionals
COVID-19 Outpatient Therapeutics
General Information for Health Care Professionals
Stanford Health Care is offering COVID-19 therapeutics for treatment or prevention in eligible patients, whether within or outside of the Stanford Health Care system, in accordance with national guidelines.
Due to the evolving variants and supply of medications, Stanford Health Care will select the specific therapeutic based individual patient factors.
Stanford Health Care reserves the right to select the monoclonal antibody for infusion based on medication supply and clinical data available at the time of referral.
Are you a patient?
For questions, please contact us at 650-391-8503.
Treatment of Patients – March 4, 2022
To learn more about currently recommended therapeutics, please visit https://www.covid19treatmentguidelines.nih.gov/.
Post-exposure prophylaxis – Jan. 19, 2022
No monoclonals active against the omicron variant are available for post-exposure prophylaxis.
Pre-exposure prophylaxis – March 4, 2022
Evusheld, a combination of tixagevimab and cilgavimab, has emergency use authorization for pre-exposure prophylaxis in patients with immune compromise Providers can now refer eligible patients for appointments (see below).
Confirming Patient Eligibility
- Positive direct SARS-CoV-2 viral testing
- Be symptomatic with onset within the previous 7 days
a. Symptoms include at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion - Meet one or more high-risk criteria (see below)
High-risk criteria
- BMI >25 kg/m2
- Chronic kidney disease
- Diabetes mellitus
- Immunosuppressive disease/therapy — this does not include:
- HIV alone with CD4 >200 CD4+ T cells/mm3
- Prednisone or prednisone equivalent <20 mg daily for <3 weeks
- Pregnancy
- Age >= 65 years
- Cardiovascular disease including congenital heart disease, hypertension
- Chronic respiratory disease including chronic obstructive pulmonary disease
- Sickle cell disease
- Neurodevelopmental disorders
To be eligible, patients must meet ALL of the following criteria:
- Fully vaccinated patients with moderate to severe immune compromise or are ineligible for COVID-19 vaccination regardless of immune status AND
- Has not received COVID-directed mAb therapy within prior 90 days that has predicted activity against current circulating strains AND
- Benefits outweigh risks of cardiovascular events AND
- Benefits outweigh risk of bleeding from intramuscular injection AND
- No COVID-19 related symptoms
** Stanford Health Care does not provide therapy to pediatric patients. Please contact the on-call Pediatric Infectious Disease team at 650-497-8000 for therapy inquiries in patients less than 18 years of age.
Referral Process Overview
Step 1: Familiarize Yourself
- Stanford Health Care reserves the right to select the monoclonal antibody for infusion based on medication supply and clinical data available at the time of referral.
- Review the Stanford Health Care Modified Emergency Use Authorization Criteria for mAbs.
Step 2: Educate the Patient
- Inform the patient that COVID-19 mAbs are unapproved therapies but are authorized for use under Emergency Use Authorization. Click here for information that may assist in explaining EUA to patients.
- Discuss the risks, benefits, and alternatives to monoclonal antibody therapies with patients by reviewing the EUA mAbs Fact Sheet for Patients, Parents, and Caregivers and providing a copy of this document, when possible.
Step 3: Refer the Patient
- If the patient is interested in pursuing therapy:
- The referral will be screened to ensure that the patient is eligible for therapy.
- If approved, the patient will be contacted via phone to schedule an appointment and will receive detailed information about what to expect.
- If denied, the patient will be informed of the reason for denial.
Step 4: Follow-up & Reporting
- If the patient experienced an adverse reaction, the provider must report it to all of the following:
- FDA MedWatch
- Manufacturer
- Enter a SAFE Event (Stanford Health Care-privileged providers only) or email DL-SHC-Pharmacy-COVID@stanfordhealthcare.org.
Step 1: Familiarize Yourself
Step 2: Educate the Patient
- Inform the patient that COVID-19 mAbs are unapproved therapies but are authorized for use under Emergency Use Authorization. Click here for information that may assist in explaining EUA to patients.
- Discuss the risks, benefits, and alternatives to monoclonal antibody therapies with patients by reviewing the EUA Fact Sheet for Patients, Parents, and Caregivers and providing a copy of this document, when possible.
Step 3: Refer the Patient
- If the patient is interested in pursuing therapy:
- The referral will be screened to ensure that the patient is eligible for therapy.
- If approved, the patient will be contacted via phone to schedule an appointment and will receive detailed information about what to expect.
- If denied, the patient will be informed of the reason for denial.
Step 4: Reporting
Providers are required to report any serious adverse event or medication errors within 7 days of the event by completing all 3 steps below:
A. Report to FDA through one of the below options
- Submit FDA Form 3500 online,
- Download this form and then submitting by mail or fax, or
- Contact the FDA at 1-800-FDA-1088 to request this form.
B. Please also provide a copy of this form to AstraZeneca by Fax at 1-866-742-7984 or call 1-800-236-9933.
C. Report SHC SAFE. If not a Stanford provider, send secure email to DL-SHC-Pharmacy-COVID@stanfordhealthcare.org.