Anti-SARS-CoV-2 Antibody Products

Anti-SARS-CoV-2 Monoclonal Antibodies

• The COVID-19 Treatment Guidelines Panel (the Panel) recommends using one of the following anti-SARS-CoV-2 monoclonal antibody combinations (listed in alphabetical order) to treat outpatients with mild to moderate COVID-19 who are at high risk of clinical progression, as defined by the Emergency Use Authorization (EUA) criteria for the products:
  • Bamlanivimab 700 mg plus etesevimab 1,400 mg (AIIa); or
  • Casirivimab 1,200 mg plus imdevimab 1,200 mg (AIIa).
• Treatment should be started as soon as possible after the patient receives a positive result on a SARS-CoV-2 antigen or nucleic acid amplification test and within 10 days of symptom onset.
• There are no comparative data to determine whether there are differences in clinical efficacy or safety between bamlanivimab plus etesevimab and casirivimab plus imdevimab.
  • There are SARS-CoV-2 variants, particularly those that contain the mutation E484K, that reduce the virus’ susceptibility to bamlanivimab and, to a lesser extent, casirivimab and etesevimab in vitro; however, the clinical impact of these mutations is not known.
  • In regions where SARS-CoV-2 variants with reduced in vitro susceptibility to bamlanivimab plus etesevimab are common, some Panel members would preferentially use casirivimab plus imdevimab while acknowledging that it is not known whether in vitro susceptibility data correlate with clinical outcomes.
• The Panel recommends against the use of anti-SARS-CoV-2 monoclonal antibodies for patients who are hospitalized because of COVID-19, except in a clinical trial (AIIa). However, their use should be considered for persons with mild to moderate COVID-19 who are hospitalized for a reason other than COVID-19 but who otherwise meet the EUA criteria.

COVID-19 Convalescent Plasma

• The Panel recommends against the use of low-titer COVID-19 convalescent plasma for the treatment of COVID-19 (AIIb). Low-titer COVID-19 convalescent plasma is no longer authorized through the convalescent plasma EUA.
• For hospitalized patients with COVID-19 who do not have impaired immunity:
  • The Panel recommends against the use of COVID-19 convalescent plasma for the treatment of COVID-19 in mechanically ventilated patients (AI).
  • The Panel recommends against the use of high-titer COVID-19 convalescent plasma for the treatment of COVID-19 in hospitalized patients who do not require mechanical ventilation, except in a clinical trial (AI).
• For hospitalized patients with COVID-19 who have impaired immunity:
  • There are insufficient data for the Panel to recommend either for or against the use of high-titer COVID-19 convalescent plasma for the treatment of COVID-19.
• For nonhospitalized patients with COVID-19:
  • There are insufficient data for the Panel to recommend either for or against the use of high-titer COVID-19 convalescent plasma for the treatment of COVID-19 in patients who are not hospitalized.

Anti-SARS-CoV-2 Specific Immunoglobulin

• There are insufficient data for the Panel to recommend either for or against the use of anti-SARS-CoV-2 specific immunoglobin for the treatment of COVID-19.