Introduction
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Bamlanivimab+Etesevimab (produced by Eli Lilly)
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Casirivimab+Imdevimab (produced by Regeneron).
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) |
Methods
Obesity
Hematological risk factors
Transplant recipients
Hearth conditions
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single ventricle patients or patients who have undergone Fontan intervention (total cavo-pulmonary connection);
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severe valvopathy;
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chronic cyanosis (SpO2 < 85%);
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therapy-dependent cardiomyopathies;
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pulmonary hypertension on treatment;
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heart-transplant recipients;
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congenital heart diseases with significative comorbidities (e.g. chronic kidney disease, chronic pulmonary disease) [30].
Respiratory conditions
Inflammatory bowel diseases (IBDs)
Liver disease
Immunodeficiencies
Risk | Category | PID examples and/or molecular defect |
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Higha | IFN-1 pathway defects PID with production of anti-IFN antibodies Combined PID Isolate/PID related CD4 lymphopenia (< 200/mmc) PID with deregulatory phenotype PID with anti-inflammatory phenotype uncontrolled by therapyb Any PID [dependent on intra-venous immunoglobulin (IVIG) substitution therapy or antibiotic prophylaxis] associated to organ damage and/or chronic infection and/or malignancy Any PID [dependent on intra-venous immunoglobulin substitution therapy or antibiotic prophylaxis] on chronic oral corticosteroid or other immunosuppressant therapy Any PID which has undergone bone marrow transplant in the last 12 months Trisomy 21 | TLR3, UNC93B1 STAT1, STAT2 APS1/APECED FHL, XIAP, RAB27A DIRA |
Intermediate | XLA, CVI excluded from high risk PID Chronic Granulomatous Disease (CGD) Complement deficits | |
Low | Minor antibodies deficiencies Minor complement deficiencies C1-inhibitor deficiency | IgA deficiency (selected cases) MBL deficiency, hereditary angioedema |
Diabetes
Kidney disease
Neurological and metabolic disorders
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respiratory muscles dysfunction with forced vital capacity (FVC) < 60% (especially if associated to kyphoscoliosis);
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non-invasive ventilation or tracheostomy;
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oropharyngeal deficit with impaired cough and/or reduced respiratory clearance;
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hearth muscle involvement;
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metabolic conditions or impairment of the neuromuscular junctions at risk of deterioration in case of fever, fasting or infection;
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diabetes, obesity and or severe arterial hypertension;
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conditions at risk for rhabdomyolysis in case of fever, fasting or infection;
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chronic immunosuppressant or corticosteroid therapy.
Additional recommendations
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: a. BMI ≥ 95° percentile for age and gender (WHO Tables) b. Haemoglobinopathy (sickle cell anemia and thalassemia major or intermedia) c. Hereditary or acquired thrombophilia d. Onco-hematological patients with lymphopenia (< 300/mmc), neutropenia (< 500/mmc), high intensity treatment (AML, induction and reinduction phase for those with ALA, NHL, hematopoietic stem cell transplant recipients (< 30 days if autologous or < 100 days if allogenic) e. Solid organ or hematopoietic stem cells transplant recipients f. Congenital or acquired hearth diseases: single ventricle physiology or status post Fontan intervention (total cavo-pulmonary connection), severe heart valve disease, chronic cyanosis (SpO2 < 85%), severe ventricular dysfunction, therapy-dependent cardiomyopathies, pulmonary hypertension on treatment. g. Chronic obstructive or restrictive lung disease requiring daily therapy or biologics (e.g. severe or uncontrolled asthma dependent on specific monoclonal antibody therapy or oral steroids for symptoms control); cystic fibrosis with moderate to severe respiratory impairment, reduced BMI, transplant recipients or with other significative comorbidities; pulmonary fibrosis; bronchiolitis obliterans; bronchopulmonary dysplasia; chronic pulmonary GVHD h. Dependence on technological device (e.g. subjects with tracheostomy and/or gastrostomy) i. Inflammatory Bowel Diseases (IBDs) on immunosuppressant therapy j. PIDs at high risk for progression to severe disease (Table 2); case by case approach for those with mild-moderate risk PIDs k. Secondary Immunodeficiencies including HIV with low lymphocyte count (CD4+ lymphocytes < 15% or < 200/mmc) or with severe comorbidities, chemotherapy (< 6 months from suspension), hematopoietic stem cells transplant (< 3 months if autologous, < 6 months if allogenic or in presence of chronic active GVHD) or solid organ transplant and protracted immunosuppressant therapies l. Uncontrolled Diabetes mellitus (HbA1c > 9% or 75 mmol/mol) or with chronic complications m. Chronic renal failure requiring hemodialysis or peritoneal dialysis n. Neurological or neuro-muscular diseases with at least one of the following: - Respiratory muscles dysfunction with FVC < 60% (especially if associated with kyphoscoliosis) - Impaired cough and reduced respiratory clearance - Hearth involvement - Metabolic conditions or impairment of the neuromuscular junctions at risk of deterioration in case of fever, fasting or infection - Conditions at risk for rhabdomyolysis in case of fever, fasting or infection - Chronic immunosuppressant or corticosteroid therapies *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) |