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Anti-SARS-CoV-2 Antibody Products

Last Updated: July 8, 2021

Summary Recommendations
Summary Recommendations

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 antibodies 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) criteriaa:
    • Casirivimab plus imdevimabb; or
    • Sotrovimab.
  • At this time, the Panel recommends against using bamlanivimab plus etesevimab (AIII) because the P.1 (Gamma) and B.1.351 (Beta) variants of concern, which have reduced susceptibility to both bamlanivimab and etesevimab, represent an increasing proportion of the circulating variants in the United States. See the Centers for Disease Control and Prevention’s (CDC) COVID Data Tracker for the latest information on variant proportion by region of the United States.
  • The quality of the evidence that supports the Panel’s recommendations for the use of anti-SARS-CoV-2 monoclonal antibodies differs based on the criteria used to define high risk of progression to severe COVID-19. Consequently, the Panel weighed the strength of the recommendations based on the evidence for the risk of progression (see the Panel’s Statement on the Emergency Use Authorizations of Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment of COVID-19). Treatment is recommended based on the FDA EUA criteria for:
    • Patients with high-risk conditions that were represented in clinical trials (AIIa), and
    • Patients with other medical conditions and factors that had limited representation in clinical trials (BIII); however, in cases where the patient has an immunocompromising condition or is receiving immunosuppressive therapy, the rating for the recommendation is AIII.
  • 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.
  • 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 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 in patients who are not hospitalized.

Anti-SARS-CoV-2 Specific Immunoglobulin

  • There is insufficient evidence for the Panel to recommend either for or against the use of anti-SARS-CoV-2 specific immunoglobin 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