Monoclonal Antibody Therapy

Novel COVID-19 monoclonal antibody therapy

Due to increased incidence of variant forms of SARS-CoV-2 which have greater resistance to monoclonal antibody monotherapies, as of March 23, 2021, it is now recommended that Utah providers exclusively use combination monoclonal antibody therapies.

In addition to Eligibility Criteria, there are a number of Inclusion Criteria as defined by the EUA that specify who is eligible for this novel treatment.

Age 16 to Adult Patient Selection and Inclusion Criteria

Age 16 to Adult Patient Selection and Inclusion Criteria: 16 years old to Adult; laboratory confirmed COVID-19 (PCR or Antigen); symptomatic, with no more than 7 days from symptom onset; Utah COVID-19 Risk Score of greater than 4.5 (5 or above). (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 for COVID 19 specifically, or COVID related complications.

Note: Monoclonal antibodies should NOT be used in patients hospitalized for COVID or COVID related issues because trials have shown that they are not useful for patients hospitalized for COVID. We realize though that there may be rare circumstances where a patient may be admitted for non-COVID reasons, and incidentally is found to have acute COVID with mild symptoms developing within prior 7 days but no new hypoxia, and is at moderate to high risk of developing severe disease according to the Risk Score, in whom treatment with MAbs may be justifiable.

Pediatric Patients Under Age 16 Inclusion Criteria (must meet ALL)

Pediatric Patients Under Age 16 Inclusion Criteria (must meet ALL): Must be at least 12 and up to and including 15 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 being admitted or already admitted to an acute care hospital for COVID 19 specifically, or COVID related complications; and MUST 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.

For pediatric patients from 12 years of age but less than age 18 years, please talk with your child’s specialist physician (e.g. rheumatologist, immunologist, or oncologist). If your child’s provider determines that your child meets the eligibility criteria, the provider should send an email regarding eligible pediatric patients to: Pediatric.MonoclonalAntibodies@imail.org

Utah COVID-19 Risk Score Calculator

Demographic Risk Factors	Points
Male	1
Age	0.5 for every decade: 16-20=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

Does antibody treatment work?

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.

What are the side effects of the antibody treatment?

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.

What should I tell my healthcare provider before I receive the antibody treatment?

How will I receive the antibody treatment?

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.

Will insurance cover antibody treatment?

The federal government is currently distributing monoclonal antibodies treatments at no cost for patients. However, depending on where you receive treatment, there may be some associated costs for administering the treatment. If you have insurance, these costs may be covered. If you do not have insurance, ask the treatment facility if there will be costs associated with receiving the treatment. More information on insurance coverage of antibody treatments can be found at CMS: Coverage of Monoclonal Antibody Products to Treat COVID-19 (PDF).

Where can I get it?

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

Ashley Regional Medical Center – 435-790-2807
Beaver Valley Hospital – 435-438-7284
Blue Mountain Hospital – 435-678-4640
Castleview Hospital – Price – 435-636-4840 / 435-650-4895
Central Valley Medical Center – 435-623-3108
Gunnison Valley Hospital – Gunnison – 435-528-2118
Intermountain Healthcare – Statewide – monoclonal.antibodies@imail.org
Kane County Hospital – Kanab – 435-644-4178
Moab Regional Hospital – 435-719-3500
Mountain West Medical Center – Tooele – 435-843-3629 / 435-830-6040
Ogden Regional Medical Center – 801-479-2470
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

Utah Crisis Standards of Care Monoclonal Antibody Allocation Guidelines - Updated 06/15/2021

Downloadable documents

COVID-19 Research Studies and Trials

Several Utah-based clinical trials and studies are underway. Some of these are listed below:

Intermountain Healthcare: ACTIV-4. This study is part of a national effort to determine if blood thinners can help prevent blood clots that can cause stroke, heart attacks, blood clots in the lungs (PE), blood clots in the legs (DVT), or even admission to the hospital in people with COVID-19 who are not initially admitted to the hospital.

University of Utah: covidplasmatrial.org, 801-587-7573. This study will test whether a transfusion of plasma that has antibodies from persons who have recovered from COVID-19 is a good treatment for patients with early COVID-19 illness. Getting plasma with COVID-19 antibodies may protect us against a severe COVID-19 infection, but we first need to conduct this study to know for sure. The study involves one plasma infusion within a day of enrollment with follow-up visits to a nearby facility (physical exam, swab test, lab tests) and telephone calls over 90 days and a symptom diary you fill out between visits.

University of Utah: covidplasmatrial.org, 801-587-7573. This study will test whether an infusion of plasma containing antibodies from recovered people can prevent uninfected people in a high-risk situation from developing COVID-19. If the trial proves to be successful, this treatment may help other people, who get exposed to the disease in the future, to not develop symptoms and possibly reduce the need for hospitalization. The study involves one plasma infusion at enrollment with follow-up visits to a nearby facility (physical exam, swab test, lab tests) and telephone calls over 90 days.

STOP COVID 2: https://stopcovidtrial.wustl.edu/, COVIDstudy@hsc.utah.edu, 385-722-4597. STOP COVID Trial is a randomized controlled trial that aims to help slow the progression of COVID-19 symptoms in symptomatic patients in the United States. The study is contactless meaning volunteers may participate without leaving their home. Medication and study supplies are delivered by a courier or shipped overnight. We hope our study will demonstrate whether or not taking a medication, fluvoxamine, will help to prevent worsening of symptoms and prevent hospitalization.

UTAH ONE: https://utahcovidtrialsinfo.utahdcc.org/,COVIDstudy@hsc.utah.edu, 385-722-4597. This research study is designed to test possible treatments for COVID-19 and should help us better understand the virus and if Hydroxychloroquine might be a good treatment.This project will help us gain important information about how to better treat COVID-19. You will be asked to take either a study drug or a placebo, our team will deliver the pills and study supplies to your house. You will be asked to swab your throat for 14 days, answer questionnaires, and provide 3 blood samples.