Guidance for use of monoclonal antibodies in COVID-19 by NIH panel

The National Institutes of Health COVID-19 Treatment Guidelines Panel recommends using one of the following combination anti-SARS-CoV-2 monoclonal antibodies to treat outpatients with mild to moderate COVID-19 who are at high risk of clinical progression.

The statement by the Panel recently highlighted the emergency use authorization of Anti-SARS-CoV-2 monoclonal antibodies for the treatment of COVID-19.

Emergency Use Authorization (EUA) criteria relays on the anti-SARS-CoV-2 monoclonal antibodies and the said combinations: bamlanivimab alone, bamlanivimab plus etesevimab, and casirivimab plus imdevimab.

The recommendations laid out included-

a. One of the following combination 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) criteria (listed in alphabetical order):

a. Bamlanivimab 700 mg plus etesevimab 1,400 mg (AIIa); or

b. Casirivimab 1,200 mg plus imdevimab 1,200 mg (AIIa).

b. 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 (NAAT) and within 10 days of symptom onset.

c. There are no comparative data to determine whether there are differences in clinical efficacy or safety between bamlanivimab plus etesevimab and casirivimab plus imdevimab.

d. There are SARS-CoV-2 variants, particularly those that contain the mutation E484K (see below), 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.

e. 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.

f. Because clinical outcome data are limited and there are concerns regarding decreased susceptibility of variants, the Panel recommends against the use of bamlanivimab monotherapy (AIII).

g. If combination products are not available, the use of bamlanivimab monotherapy can be considered for people who meet the EUA criteria on a case-by-case basis.

h. 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.

The FDA EUAs for all available anti-SARS-CoV-2 monoclonal antibodies and combinations have the same criteria for use wherein they allow for the use of the monoclonal antibodies for the treatment of COVID-19 in nonhospitalized adults and children aged ≥12 years and weighing ≥40 kg who are at high risk for progressing to severe COVID-19 and/or hospitalization.