AZD7442 Pharmacokinetics, Pharmacodynamics, and safety evaluation in pediatrics - TRUST

Inclusion Criteria

• - Participant must be aged ≥ 29 weeks gestational age (GA) to < 18 years of age.
• - Participant must weigh a minimum of 1.5 kg.
• COHORT 1
• - Increased risk of severe COVID-19 because of immunocompromised state or one or more comorbid conditions that increase the risk of severe COVID-19.
• - Increased risk for SARS-CoV-2 infection.
• - Medically stable (disease not requiring significant change in therapy or hospitalization for worsening disease during the one month prior to enrollment).
• - A negative RT-PCR test collected ≤ 3 days prior to Day 1 or a negative rapid SARS-CoV-2 antigen test at screening.
• - No COVID-19 symptoms prior to enrollment within 10 days of dosing.
• - Increased risk for SARS-CoV-2 infection.
• COHORT 2
• - Increased risk of severe COVID-19 because of immunocompromised state or one or more comorbid conditions that increase the risk of severe COVID-19.
• - Medically stable (disease not requiring significant change in therapy or hospitalization for worsening disease during the one month prior to enrollment).
• - A positive RT-PCR test collected ≤ 3 days prior to Day 1 or a positive rapid SARS-CoV-2 antigen test at screening.
• - Symptomatic participants must be dosed with IMP no more than 7 days from the self-reported date of first reported sign/symptom.
• - Oxygenation saturation of ≥ 92% obtained at rest within 24 hours prior to Day 1 unless the potential participant regularly receives chronic supplementary oxygen for an underlying lung condition.
• Note that Cohort 2 will only be included if the indication is progressed in adults.
• COHORT 3
• - Participants hospitalized with COVID-19 with a time between onset of symptoms and dosing AZD7442 of ≤ 7 days.
• - A positive RT-PCR test collected ≤ 3 days before Day 1 or a positive rapid SARS-CoV-2 antigen test at screening.
• - Spontaneous blood Alanine Aminotransferase (ALT)/Aspartate Transaminase (AST) levels ≤ 5 times the ULN.
• - Glomerular Filtration Rate (GFR) ≥ 30 mL/min/1.73 m2.
• Participants will receive IM AZD7442 unless they meet any of the following criteria for IV
• administration:
• • The participant has severe COVID-19.
• • Contraindication of intramuscular (IM) dose due to thrombocytopenia, coagulation defects or any other condition that would compromise the absorption of AZD7442 or safety of the participant.
• • Physician considers IV the appropriate route.