AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics
a study on COVID-19
Summary
- Eligibility
- for people ages up to 17 years (full criteria)
- Location
- at UCLA
- Dates
- study startedestimated completion
Description
Summary
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD7442 administered intramuscularly (IM) or intravenously (IV) in pediatric participants aged ≥ 29 weeks GA to < 18 years.
Official Title
Open-Label, Uncontrolled, Single Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of AZD7442 in Pediatric Participants Aged ≥ 29 Weeks Gestational Age to < 18 Years
Details
This is a Phase I, open-label, uncontrolled, multi-country, multi-center, single-dose study. Initially, 2 cohorts of participants will be enrolled: 1) participants who are severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) negative at screening and have not knowingly been exposed to a SARS-CoV-2 positive individual (pre-exposure prophylaxis); and 2) participants who are SARS-CoV-2 RT-PCR positive at screening and have mild to moderate COVID-19 symptoms. A third cohort might be added for the treatment of severe COVID-19. If included, this third cohort will include participants who are SARS-CoV-2 positive at screening and have severe COVID-19.
Keywords
SARS-CoV-2 AZD7442 Monoclonal antibodies (mAb) COVID-19 EVUSHELD
Eligibility
You can join if…
Open to people ages up to 17 years
- 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.
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.
Participants will receive IM AZD7442 unless they meet any of the following criteria for IV administration:
- 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.
- A central IV line. - Physician considers IV the appropriate route.
You CAN'T join if...
All Cohorts
- Cohort 1: Significant infection or other acute illnesses including fever on or the day prior to receiving AZD7442.
- History of SARS-CoV-1 or Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
- Cohorts 1 and 2: Current need for immediate medical attention or current need for hospitalization.
- Mechanical ventilation or extracorporeal membrane oxygenation requirement for COVID-19.
- History of allergic or reaction to any component of the study drug formulation.
- History of hypersensitivity, injection/infusion-relation reactions or severe adverse reactions following administration of a monoclonal antibody (mAb).
- Co-morbidity requiring surgery within 7 days prior to study entry or is deemed life-threatening within 30 days prior to study entry.
- Prior receipt of convalescent COVID-19 plasma/sera or hyperimmune globulin therapy.
- Prior receipt of mAb/biologic indicated for the prevention of SARS-CoV-2, treatment of COVID-19, or expected receipt during the period of study follow-up.
- Prior receipt of a COVID-19 vaccine < 60 days before screening.
- Post-pubertal females who are pregnant or breast-feeding.
- History of alcohol or drug abuse or positive urine drug or alcohol screening within the past 2 years.
Locations
- Research Site
not yet accepting patients
Los Angeles California 90095 United States - Research Site
accepting new patients
Long Beach California 90806 United States
Details
- Status
- accepting new patients at some sites,
but this study is not currently recruiting here - Start Date
- Completion Date
- (estimated)
- Sponsor
- AstraZeneca
- ID
- NCT05281601
- Phase
- Phase 1 COVID-19 Research Study
- Study Type
- Interventional
- Participants
- Expecting 100 study participants
- Last Updated