Monoclonal Antibody Therapy

Adult Patient Selection and Inclusion Criteria: Adults 18 years old or older; laboratory confirmed COVID-19 (PCR or Antigen); symptomatic, with no more than 7 days from symptom onset; Utah COVID-19 Risk Score greater than 7 (this cutoff will be adjusted based on additional supply of medication from the Federal Government, check with medical provider if questions); NO NEW hypoxemia (in need of new or increased supplemental oxygen and/or and oxygen level at rest of less than 90% [SpO2<90%]); NOT being admitted or already admitted to an acute care hospital; NOT pregnant (inadequate safety data).

Pediatric Inclusion Criteria (must meet ALL): Between 12 and 18 years of age; at least 88 pounds (40kg); laboratory confirmed COVID-19 (PCR or Antigen); symptomatic, with no more than 7 days from symptom onset; NOT hospitalized; NOT pregnant; and have B-cell immunodeficiency [primary or acquired (e.g. rituximab therapy, certain types of cancer treatment that are B-cell depleting therapies)].

Pediatric Criteria Rationale: Children have a lower risk of hospitalization from COVID-19 infection than adults and therefore are less likely to benefit from monoclonal antibody therapy. Studies using COVID-19 monoclonal antibody therapy have NOT included children so it is unclear if children would benefit from the drug. In addition to the uncertainty of benefit, although rare, there is a risk of anaphylaxis and infusion related reaction with the administration of the COVID-19 antibody therapy. We do not have enough information to know if the potential benefits of this therapy in children outweigh the risks.

A serious effect of COVID-19 in children is multisystem inflammatory syndrome in children (MIS-C). This is a condition where multiple organs such as the heart, lungs, brain, kidneys, skin, eyes, and gastrointestinal system become inflamed. Although we do not fully understand what causes this, antibodies to COVID-19 are found in the blood of most children with MIS-C. We do NOT know the effect of COVID-19 monoclonal antibody therapy on risk of MIS-C.

Given that children are less likely to benefit from COVID-19 monoclonal antibody than adults (even adolescents with high-risk conditions), the unknown benefit and the lack of safety information for this drug in children, monoclonal antibody therapy should be considered experimental and should only be considered for children at highest risk of serious complication.

Below are the children that may be considered on a case-by-case basis for therapy. If your child meets the criteria below and you are interested in COVID-19 monoclonal antibody therapy, please talk with your child’s specialist physician (e.g. rheumatologist, immunologist, or oncologist). If you and your child’s provider determine that your child meets the eligibility criteria, your provider can call a member of the children’s infectious diseases or rheumatology team to further discuss eligibility and next steps.

Providers should send an email regarding eligible pediatric patients to: Pediatric.MonoclonalAntibodies@imail.org

Demographic Risk Factors	Points
Male	1
Age	0.5 for every decade: 18-20=1, 21-30=1.5, 31-40=2, 41- 50=2.5, 51-60=3, 61-70=3.5, 71-80=4, 81-90=4.5, 91-100=5, >100=5.5
Non-White Race or Hispanic/Latinx Ethnicity	2
Highest-Risk Comorbidities
Diabetes melitus	2
Severely Immunocompromised	2
Obesity (BMI>30) calculator	2
Other High-Risk Comorbidities
Hypertension	1
Coronary artery disease	1
Cardiac Arrhythmia	1
Congestive Heart Failure	1
Chronic Kidney Disease	1
Chronic Pulmonary Disease	1
Chronic Liver Disease	1
Cerebrovascular disease	1
Chronic Neurologic disease	1
Symptom Risk Factor
New Shortness of Breath	1
Total

Clinical trials for bamlanivimab and for casirivimab/imdevimab have shown a decrease in hospitalizations and emergency room visits and a decrease in the amount of virus in an infected person’s blood. Studies are still ongoing.

• New England Journal of Medicine: SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19
• Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

The most common reported side effects with bamlanivimab are nausea, diarrhea, dizziness, headache, itchiness, and vomiting. The most common reported side effects with casirivimab/imdevimab are nausea and vomiting, hyperglycemia, and pneumonia. The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

In clinical trials of bamlanivimab and casirivimab/imdevimab involving nearly 3,000 people, two severe allergic reactions and five serious reactions related to the delivery of the treatment into the vein were reported. All reactions were treated and resolved.

Please review the fact sheets here prior to receiving the treatment, if you have questions you should speak with your healthcare provider. 

• Fact Sheet for Patients, Parents and Caregivers Emergency Use Authorization (EUA) of Bamlanivimab for Coronavirus Disease 2019 (COVID-19) (PDF)
•  Fact Sheet for Patients, Parents and Caregivers Emergency Use Authorization (EUA) of Casirivimab and Imdevimab for Coronavirus Disease 2019 (PDF)

• All of your medical conditions
• If you have any allergies
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed
• Have any serious illnesses
• Are taking any medications (prescription, over-the-counter, vitamins, and herbal products)

Casirivimab and Imdevimab

• Casirivimab and imdevimab are two investigational medicines given together as a single intravenous infusion (through a vein) for at least 1 hour.
• You will receive one dose of casirivimab and imdevimab by intravenous infusion.

Bamlanivimab

• Bamlanivimab is given to you through a vein (intravenous or IV) for at least 1 hour.
• You will receive one dose of bamlanivimab by IV infusion.

List of Participating Healthcare Providers – Updated 12/15/2020

• Ashley Regional Medical Center – Vernal – 435-790-280

• Castleview Hospital – Price – 435-636-4840 / 435-650-4895

• Central Valley Medical Center – Nephi –

• Gunnison Valley Hospital – Gunnison – 435-528-2118

• Intermountain Healthcare – Statewide – monoclonal.antibodies@imail.org

• Kane County Hospital – Kanab – 435-644-4178

• Moab Regional Hospital – Moab –

• Mountain West Medical Center – Tooele – 435-843-3629 / 435-830-6040

• Uintah Basin Medical Center – Roosevelt – 435-247-4298

• University of Utah Health – SLC – 801-213-2130

• Davis Hospital and Medical Center – Layton –Please contact your Primary Care Physician to schedule an appointment
• Jordan Valley Medical Center – West Jordan – Please contact your Primary Care Physician to schedule an appointment
• Mountain Point Medical Center – Lehi – Please contact your Primary Care Physician to schedule an appointment 
• Salt Lake Regional Medical Center – Salt Lake City –Please contact your Primary Care Physician to schedule an appointment

For general program information contact UDOH at healthcarepreparedness@utah.gov

Read the Utah Crisis Standards of Care Monoclonal Antibody Allocation Guidelines in full here.

• Monoclonal Antibodies Flyer
• Monoclonal Antibodies FAQ page