Table 1.

AIFA’s indications for the use of anti-SARS-CoV-2 mAbs in subjects between 12 and 17 years old

Patients aged ≥12 years old, who tested positive for SARS-CoV-2, with mild-moderate disease, a recent onset (less than 10 days, except for patients with immunodeficiency and persistently positive molecular test but negative serologic test)* and the presence of risk factors for severe disease: - Body Mass Index (BMI) ≥95°percentile for age and gender - Chronic renal failure, including hemodialysis or peritoneal dialysis - Uncontrolled Diabetes mellitus (HbA1c > 9% or 75 mmol/mol) or with chronic complications - Primary and secondary Immunodeficiencies - Haemoglobinopathies - Cerebral vascular diseases (including high blood pressure with organ damage) - Neurodevelopment and degenerative diseases - Chronic obstructive pulmonary disease e/o other respiratory chronic conditions (for examples asthma, pulmonary fibrosis or condition requiring oxygen therapy not for SARS-CoV-2) - Chronic hepatopathy (with following box warning: “mAbs have not been studied in patients with moderate or severe hepatic impairment”) *Bamlanivimab+Etesevimab is approved for outpatients (not-hospitalized patients) without supplemental oxygen therapy for COVID 19; Casirivimab+Imdevimab is approved also for hospitalized patients and for patients with conventional oxygen therapy (excluding high flow and mechanical ventilation)