Table 2.
Use of NAbs: Approved patient populations |
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Bamlanivimab/etesevimab [23] and casirivimab/imdevimab [24] have received conditional/emergency use authorization for the treatment of non-hospitalized patients with mild/moderate SARS-CoV-2 infection considered at high risk of progression to severe COVID-19:
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Monoclonal antibodies, such as bamlanivimab plus etesevimab, and casirivimab plus imdevimab, and sotrovimab ‘may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation’. Therefore, these agents are not authorized for use in patients who:
Sotrovimab has received conditional/emergency use authorization for the treatment of non-hospitalized mild/moderate COVID-19 in adults and pediatric patients (≥12 years of age and weighing ≥40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk of progression to severe COVID-19, including hospitalization or death [74,75]:
The EMA has approved casirivimab/imdevimab for the treatment of COVID-19 in adults and adolescents aged ≥12 years and weighing ≥40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 [19]. The EMA has approved regdanvimab for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19, defined as having at least one of the following risk factors [26]:
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AIDS: acquired immunodeficiency syndrome; BMI: body mass index; CHMP: Committee for Medicinal Products for Human Use; COVID-19: coronavirus disease 2019; HIV: human immunodeficiency virus; NAb: neutralizing antibody.