Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting

Use of Monoclonal Antibodies (Bamlanivimab and Casirivimab + Imdevimab) for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting

No therapeutic agent is currently approved for the treatment of SARSCoV-2 infection. More importantly, no intervention is currently available to mitigate the progression of disease from mid/moderate to serve particularly in high risk patients. Recognizing this limitation and urgency of finding a treatment for COVID-19, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergencyuse of the unapproved product bamlanivimab or casirivimab + imdevimab for the treatment of mild to moderate coronavirus disease 2019 (COVID19) in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Inclusion Criteria:

1. adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing
2. 12 years of age and older weighing at least 40 kg
3. are at ":high risk" for progressing to severe COVID-19 and/or hospitalization

High risk is defined as patients who meet at least one of the following criteria:

1. Have a body mass index (BMI) >35
2. Have chronic kidney disease
3. Have diabetes
4. Have immunosuppressive disease
5. Are currently receiving immunosuppressive treatment
6. Are over 65 years of age
7. Are over 55 years of age AND have: cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease
8. Are 12 - 17 years of age AND have
9. BMI >85th percentile for their age and gender based on CDC o growth charts, ii. sickle cell disease OR iii. congenital or acquired heart disease OR iv. neurodevelopmental disorders, for example, cerebral palsy, OR a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR

v. asthma, reactive airway or other chronic respiratory disease o that requires daily medication for control.

Exclusion Criteria

1. Younger than 12 years of age
2. Do not meet criteria to be classified as "high risk'