LTC Monoclonal Antibody Protocols
Monoclonal antibody (mAb) therapy are treatments that may reduce the risk of severe COVID19 disease and hospitalization. Monoclonal antibody treatment is indicated for persons with a positive COVID-19 test result, and for persons with a known exposure to COVID-19. The goal of this therapy is to reduce viral loads through neutralization of the COVID-19 virus, lessen symptom severity, and help prevent hospitalizations. Persons who may benefit from mAb treatments include those with risk factors for development of severe COVID-19 disease. Monoclonal antibody (mAb) treatments can currently be administered either by intravenous or subcutaneous routes.
Who is Eligible?
Adult or pediatric (>12 years of age and weighing at least 40 kg) patients at high-risk for progressing to severe disease or death.
Patients who are COVID-19 positive, with mild-to-moderate symptoms, not hospitalized due to COVID-19 symptoms, and not requiring oxygen or an increase in home oxygen therapy are eligible, regardless of vaccination status.
Post-Exposure Prophylaxis (PEP)
Individuals who are not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS- CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) and
- have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per CDC or
- who are at high risk of exposure to an individual infected with SARS-CoV-2
Risk Factors for Development of Severe COVID-19 Include, but are not Limited to
(for both treatment and PEP indications)
- Older age (for example > 65 years of age)
- Obesity or being overweight (for example, adults with BMI ≥ 25, or if age 12-17, have BMI > 85th percentile for their age and gender based on CDC growth charts)
- Chronic kidney disease
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease (including congenital heart disease) or hypertension
- Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis, and pulmonary hypertension)
- Sickle cell disease
- Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital abnormalities)
- Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of mAb therapy is not limited to the medical conditions or factors listed above. (For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, visit the CDC website).
Identification of patients who may need mAb Therapy:
- In outbreak settings: Once the index (i.e., initial) case is identified, and SARSCoV-2 testing is completed for all potentially exposed residents and staff, ideally within 48 hours, ALL positive residents could be offered mAb therapy within 10 days of their positive test result. All those who test negative and are either: (a) unvaccinated or (b) have any risk factor for progression to disease (see list of risk factors above) could be offered mAb therapy as post-exposure prophylaxis within 7 days of the exposure. If exposure dynamics are unknown, mAb therapy could be offered within 7 days from the test date of the index case.
- Note: Residents and staff can receive mAb any time after receipt of COVID-19 vaccination. However, if they receive mAb first, it is feasible to defer vaccination by 90 days since the risk of re-infection is low in the 90 days after COVID-19 infection or receipt of passive antibody therapy. Per HHS, Receipt of passive antibody therapy in the past 90 days is not a contraindication to receipt of COVID-19 vaccine. COVID-19 vaccine doses received within 90 days after receipt of passive antibody therapy do not need to be repeated.
- In non-outbreak settings: Cases may be detected during SARS-CoV-2 testing of new admitted or symptomatic residents, and on unvaccinated staff at least weekly or more frequently based on community transmission levels, per current IDPH guidance for testing in long term care facilities.
People who test positive could be notified of their results in person at the congregate care facility or via phone (or telehealth clinic) by the ordering provider or primary care provider using current/existing notification practices. Monoclonal antibody (mAb) therapy could be offered to patients at that time.