Monoclonal Antibodies for Treatment of COVD-19

CMH administers monoclonal antibody infusion treatments for patients with COVID-19.

Regen-Cov box and vial

Monoclonal Antibody Treatment

The FDA has issued an Emergency Use Authorization to permit the emergency use of three unapproved monoclonal antibody products including bamlanivimab plus etesevimab, casirivimab plus imdevimab (REGEN-COV), and sotrovimab 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.

REGEN-COV has also been approved for post-exposure prophylaxis in patients who are not fully vaccinated or who are not expected to mount an adequate immune response to vaccination and are at high risk of exposure in an institutional setting. 

Treatment must be given within 10 days of symptom onset. The greatest benefit is seen when given within 72 hours of a positive test result and before symptoms get worse.

Who Qualifies?

Monoclonal antibody treatment is NOT authorized for use in patients:

  • Who are hospitalized due to COVID-19, or
  • Who require oxygen therapy due to COVID-19, or
  • Who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

Benefit of treatment of monoclonal antibodies has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

The anti-SARS-CoV-2 monoclonal antibodies EUAs define high risk as patients who meet at least one of the following criteria

  • Older age (for example, age ≥65 years of age)
  • Obesity or being overweight (for example, BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm)
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • 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 anomalies)
  • Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID 19)

Monoclonal Antibodies Infusion

Monoclonal antibodies are administered via IV infusion over at least 30-60 minutes. Patients who are approved for therapy will be contacted by a CMH Infusion Center staff member to set up an appointment. Patients will receive instructions for arrival and check-in at that time. Patients will be provided with the EUA Fact Sheet before infusion. Patients are required to stay at the infusion site for one hour of observation following their infusion.

CMH Infusion Center

Monoclonal antibody infusions are scheduled Monday-Friday, 8 a.m. – 4 p.m. Call 417-328-4300 to find out if you are a candidate for a monoclonal antibody infusion for the treatment of mild to moderate COVID-19.