II. Indications
- FDA Emergency Use Indications (none are FDA approved for routine use in December 2020)
- Confirmed positive COVID-19 testing AND
- High Risk Patients for Serious Complications (see High Risk Factors in Covid-19 Infection) AND
- Patient NOT hospitalized for COVID-19 AND
- Patient not requiring Supplemental Oxygen for COVID-19
- No increase in Supplemental Oxygen if chronic use (e.g. oxygen dependent COPD)
III. Preparations (Outpatient Infusions)
- Indications
- Age>=12 years old AND weight >=40 kg AND
- Mild to moderate COVID-19 (non-hypoxic) and risk for severe disease or in unvaccinated, significant exposure
- Recommended as soon as possible (within 10 days of symptom onset)
-
General
- Rare Hypersensitivity Reactions have occurred
- As of January 2021, many insurers in U.S. are covering doses
- Defer Covid-19 Vaccination for at least 90 days after Monoclonal Antibody dose
- These monoclonal antibodies may interfere with Vaccine immune response
- Combination Casirivimab and Imdevimab (Regen-COV)
- Casirivimab 600 mg and Imdevimab 600 mg infused over 1 hour (or divided over 4 SQ Injections)
- https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/
- Indicated in mild to moderate COVID-19, age >12 years with increased risk for severe disease
- Also indicated for unvaccinated (or partially vaccinated) exposed patients
- Exposure within 6 feet for >15 minutes OR
- High risk of exposure to COVID-19 positive patient in institutional setting (e.g. Nursing Home)
- Other monoclonal Antibodies under investigation
- Bebtelovimab
- Under FDA emergency authorization for omicron variant and BA.2 Variant as of february 2022
- For age >=12 years old (weight >=40 kg) at one dose of 175 mg IV with no renal or hepatic adjustment
- Combination: Bamlanivimab and Etesevimab
- Early data with possible mortality reduction of 2%
- (2021) Presc Lett 28(4):20-1
- Bamlanivimab (Lilly product, LY-COV555)
- Bamlanivimab 700 mg in 20 ml infused over 1 hour
- Replaced by combination product with Etesevimab
- https://www.covid19treatmentguidelines.nih.gov/statement-on-bamlanivimab-eua/
- Bebtelovimab
IV. Efficacy
- As of 2023, does not appear effective against current variants
- Monoclonal Antibody helps prevent SARS-CoV-2 from entering the cell
- Seemed very promising for COVID-19 treatment as of December 2020
- Treatment results have been surprisingly mediocre
- Casirivimab and Imdevimab appear very effective in Post-exposure Prophylaxis
- NNT dose within 96 hours of exposure: 18 to prevent 1 case of COVID-19 within 28 days
- Shortens COVID-19 symptoms by 2 weeks in those who do develop COVID-19
- Reduces COVID-19 hospitalizations and mortality
- (2021) Presc Lett 28(9): 49-50
- O'Brien (2021) N Engl J Med 385:1184-95 [PubMed]