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U.S. Department of Health and Human Services

Monoclonal Antibodies for COVID-19: The Clinical Evidence

Patient receiving an IV infusion treatment

Monoclonal antibodies are laboratory-produced proteins that act as substitute antibodies to restore, enhance, or mimic the immune system’s attack on cells. Given the novel nature of SARS-CoV-2, the virus that causes COVID-19, the science is evolving rapidly. This information sheet provides the latest clinical evidence available.


Clinical Trials and FDA Emergency Use Authorizations

The U.S. Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs) for the following anti-SARS-CoV-2 monoclonal antibodies.


Setting

Available Treatment

Administration*

Dose

NIH Treatment Guidelines

Learn More>

Post-Exposure Prophylaxis (outpatient)

REGEN-COV™ (Casirivimab and Imdevimab)

IV or SQ

600 mg of casirivimab and 600 mg of imdevimab

Not Addressed in Guidelines

Treatment of Mild to Moderate COVID-19 (outpatient)

REGEN-COV™ (Casirivimab and Imdevimab)

IV or SQ

600 mg of casirivimab and 600 mg of imdevimab

Recommends Use
Strong recommendation based on other randomized trials or subgroup analyses of randomized trials

Bamlanivimab and Etesevimab Distribution paused nationally on
June 25, 2021

 

IV

bamlanivimab 700 mg and etesevimab 1,400 mg

Recommends Against Use
Strong recommendation based on expert opinion

Sotrovimab

 

IV

500-mg sotrovimab

Recommends Use
Strong recommendation based on other randomized trials or subgroup analyses of randomized trials

Treatment of COVID-19 (inpatient)

Actemra® (tocilizumab)

IV

See Healthcare Provider Fact Sheet

Recommends Use
Moderate recommendation based on other randomized trials or subgroup analyses of randomized trials


NIH Treatment Guidelines

The NIH COVID-19 Treatment Guidelines Panel recommends (AIIa) using either REGEN-COV (casirivimab and imdevimab) or sotrovimab to treat outpatients with mild to moderate COVID-19 who are at high risk of clinical progression, as defined by the Emergency Use Authorization. Furthermore, the Panel recommends against the use of bamlanivimab plus etesevimab (AIII) at this time, due to the increasing prevalence of circulating variants in the U.S. These include the P.1 (Gamma) and B.1.351 (Beta) variants of concern, which have reduced susceptibility to both bamlanivimab and etesevimab.7 The Panel also recommends (BIIa) the use of tocilizumab in the inpatient setting for certain patients, as defined by the EUA.8


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


  • This page last reviewed: October 01, 2021