Monoclonal Antibody Therapy

Novel COVID-19 monoclonal antibody therapy

Due to increased incidence of variant forms of SARS-CoV-2 which have differing resistance to monoclonal antibody therapies, as of August 27, 2021, it is now recommended that Utah providers utilize any of the following formulations, if access to these products are available:

casirivimab-imdevimab (Regeneron)
sotrovimab
bamlanivimab and etesevimab

Products approved by FDA for use in Utah will be updated based on changes to CDC, FDA, and HHS guidance.

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.

For more information about monoclonal antibody therapy, click here.

Age 16 to Adult Patient Selection and Inclusion Criteria:

16 years old to Adult; test confirmed COVID-19 (PCR or Antigen(home or laboratory test)); symptomatic, with no more than 7 days from symptom onset; 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.¹

IF meeting above inclusion criteria AND pregnant, then the patient is eligible.²

IF meeting above inclusion criteria AND NOT pregnant, determine eligibility based on vaccination status:

IF NOT fully vaccinated(3) against COVID-19, the patient must have a Utah COVID-19 Risk Score greater than 4.5 (5 or more).

IF fully vaccinated(3), the patient must have a Utah COVID-19 Risk Score greater than 8 (8.5 or more) OR be severely immunocompromised. This includes solid organ or hematopoietic stem cell recipients, patients with cancer on active chemotherapy, patients on biologics and other immunosuppressive medications that impair humoral or cell mediated immunity (including chronic steroids >20mg/day prednisone equivalent), hypogammaglobulinemia, and patients with HIV with CD4 <2005(4).

Notes: 1. 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. There may be 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. 2. We strongly recommend that monoclonal antibody therapy be considered for pregnant patients, given their greater risk for progression to severe COVID-19 disease and the continued lack of evidence of harm to the mother or fetus. 3. Fully vaccinated is defined as having one dose of the Johnson and Johnson vaccine, or 2 doses of an mRNA vaccine (Pfizer or Moderna). 4. Please refer to the “Why” section under Scope of This Document on page 2 for background.

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); test confirmed COVID-19 (PCR or Antigen(home or laboratory test)); 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 either:

B-cell immunodeficiency [primary or acquired (e.g. rituximab therapy, certain types of cancer treatment that are B-cell depleting therapies)]
BMI greater than or equal to 35

Pediatric Criteria Rationale: Children have a lower risk of hospitalization from COVID19 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. Although rare, there is a risk of anaphylaxis and infusion related reaction with the administration of the COVID-19 antibody therapy. 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. Our hospitalization data supports the use of Mab only in the two groups of patients listed above.

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. We do NOT know the effect of COVID-19 monoclonal antibody therapy on risk of MIS-C.

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?

What are the side effects of the antibody treatment?

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

How will I receive the antibody treatment?

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
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 09/01/2021

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.