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Anti-SARS-CoV-2 Antibody Products

Last Updated: October 19, 2021

Summary Recommendations
Summary Recommendations

Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment of COVID-19

  • The COVID-19 Treatment Guidelines Panel (the Panel) recommends using one of the following anti-SARS-CoV-2 monoclonal antibody (mAb) products (listed alphabetically and not in order of preference) to treat nonhospitalized patients with mild to moderate COVID-19 who are at high risk of clinical progression, as defined by criteria in the Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs) for the products:
    • Bamlanivimab 700 mg plus etesevimab 1,400 mg administered as an intravenous (IV) infusion in regions where the combined frequency of potentially resistant SARS-CoV-2 variants is low (see the FDA webpage Bamlanivimab and Etesevimab Authorized States, Territories, and U.S. Jurisdictions); or
    • Casirivimab 600 mg plus imdevimab 600 mg administered as an IV infusion or as subcutaneous (SQ) injections; or
    • Sotrovimab 500 mg administered as an IV infusion
  • When using casirivimab plus imdevimab, the Panel recommends:
    • Casirivimab 600 mg plus imdevimab 600 mg administered as an IV infusion (AIIa)
    • If an IV infusion is not feasible or would cause a delay in treatment, casirivimab 600 mg plus imdevimab 600 mg can be administered as four SQ injections (2.5 mL per injection) (BIII).
  • The strength of the evidence for using anti-SARS-CoV-2 mAbs varies depending on the medical conditions and other factors that place patients at risk for progression to severe COVID-19 and/or hospitalization (see Anti-SARS-CoV-2 Monoclonal Antibodies). The ratings for the recommendations for using anti-SARS-CoV-2 mAbs as treatment are based on the FDA EUA criteria for:
    • High-risk conditions that were represented in patients in clinical trials (AIIa), and
    • Other medical conditions and factors that had limited representation in patients in clinical trials (BIII); however, for immunocompromising conditions or receipt of immunosuppressive therapy, the rating is AIII.
  • When using anti-SARS-CoV-2 mAbs, treatment should be started as soon as possible after the patient receives a positive result on a SARS-CoV-2 antigen test or nucleic acid amplification test (NAAT) and within 10 days of symptom onset.
  • The availability of bamlanivimab plus etesevimab was previously restricted in areas with an elevated combined frequency of variants that have markedly reduced in vitro susceptibility to these agents (e.g., the Gamma and Beta variants). See the FDA webpage Bamlanivimab and Etesevimab Authorized States, Territories, and U.S. Jurisdictions for updates on the distribution of bamlanivimab plus etesevimab.
  • The use of anti-SARS-CoV-2 mAbs should be considered for patients with mild to moderate COVID-19 who are hospitalized for a reason other than COVID-19 if they otherwise meet EUA criteria for outpatient treatment.
  • Anti-SARS-CoV-2 mAbs are not currently authorized for use in patients who are hospitalized with severe COVID-19; however, they may be available through expanded access programs for patients who either have not developed an antibody response or are not expected to mount an effective immune response to SARS-CoV-2 infection.

Anti-SARS-CoV-2 Monoclonal Antibodies as Post-Exposure Prophylaxis for SARS-CoV-2 Infection

  • The Panel recommends using one of the following anti-SARS-CoV-2 mAb combinations as post-exposure prophylaxis (PEP) for people who are at high risk for progression to severe COVID-19 if infected with SARS-CoV-2 AND who have the vaccination status AND exposure history as outlined in the Prevention of SARS-CoV-2 Infection section:
    • Bamlanivimab 700 mg plus etesevimab 1,400 mg administered as an IV infusion; or
    • Casirivimab 600 mg plus imdevimab 600 mg administered as SQ injections (AI) or as an IV infusion (BIII).

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 is insufficient evidence 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 is insufficient evidence for the Panel to recommend either for or against the use of high-titer COVID-19 convalescent plasma for the treatment of COVID-19.

Anti-SARS-CoV-2 Specific Immunoglobulins

  • There is insufficient evidence for the Panel to recommend either for or against the use of anti-SARS-CoV-2 specific immunoglobulins for the treatment of COVID-19.
Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = One or more randomized trials without major limitations; IIa = Other randomized trials or subgroup analyses of randomized trials; IIb = Nonrandomized trials or observational cohort studies; III = Expert opinion