Table 2.

Eligibility criteria for NAb therapy in the treatment of COVID-19

Use of NAbs: Approved patient populations
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: Older age (e.g. ≥65 years) Obesity or being overweight (e.g. adults with BMI >25 kg/m2, or if aged 12–17 years, BMI ≥85th percentile for their age and sex) Pregnancy Chronic kidney disease Diabetes Immunosuppressive disease or immunosuppressive treatment Cardiovascular disease (including congenital heart disease) or hypertension Chronic lung diseases (e.g. chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension) Sickle cell disease Neurodevelopmental disorders (e.g. cerebral palsy) or other conditions that confer medical complexity (e.g. genetic or metabolic syndromes and severe congenital anomalies) Having a medical-related technological dependence (e.g. tracheostomy, gastrostomy or positive pressure ventilation [not related to COVID-19])
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: Are hospitalized due to COVID-19 Require oxygen therapy due to COVID-19 Require an increase in baseline oxygen flow rate due to COVID-19 (among those on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity). 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]: Older age (e.g. ≥65 years) Obesity or being overweight Pregnancy Chronic kidney disease Diabetes Immunosuppressive disease or immunosuppressive treatment Cardiovascular disease or hypertension Chronic lung diseases Sickle cell disease Neurodevelopmental disorders or other conditions that confer medical complexity Having a medical-related technological dependence (e.g. tracheostomy, gastrostomy or positive pressure ventilation [not related to COVID-19]) 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]: Age >50 years BMI >30 kg/m2 Cardiovascular disease, including hypertension Chronic lung disease, including asthma Type 1 or type 2 diabetes mellitus Chronic kidney disease, including those on dialysis Chronic liver disease Immunosuppressed, based on investigator’s assessment

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.