AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics

NCT ID: NCT05281601

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-21
• Study Completion Date: 2024-04-16

Brief 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.

Detailed Description

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.

Conditions

SARS-CoV-2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AZD7442

All participants will receive a single dose of AZD7442 on Day 1, either IM (AZD8895 followed by AZD1061) or IV (AZD8895 + AZD1061 concurrently).

Group Type: EXPERIMENTAL

AZD7442

Intervention Type: DRUG

IM Administration: AZD8895 and AZD1061 (comprising AZD7442), must both be administered separately to the participant in a sequential order.

IV Administration: AZD7442 is dosed by co-administration of AZD8895 and AZD1061 in a single IV infusion.

Interventions

AZD7442

IM Administration: AZD8895 and AZD1061 (comprising AZD7442), must both be administered separately to the participant in a sequential order.

IV Administration: AZD7442 is dosed by co-administration of AZD8895 and AZD1061 in a single IV infusion.

Intervention Type: DRUG

Other Intervention Names

Evusheld

Eligibility Criteria

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.

Exclusion Criteria

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 ≤ 14 days before screening or plan to receive a COVID-19 vaccination ≤ 14 days after IMP administration at study Visit 1.
• History of alcohol or drug abuse within the past 2 years.
• Investigational Drugs or Devices: Treatment with investigational drug or device in another clinical trial within the last 30 days or 5 half-lives of the drug (whichever is longer) prior to screening. Note: Participation in observational studies (ie, studies that do not require medication, blood draws, or an additional intervention) is not exclusionary. Interventional trials which do not include investigational drugs (only include approved therapies), or investigational treatment regimens may be considered if the blood draw requirements and study interventions are minimal and not deemed by the Investigator to interfere with completion of the planned study sampling and follow-up.
• Vulnerable persons (eg, ward of the state, kept in detention).

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Long Beach, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Washington D.C., District of Columbia, United States

Research Site

Idaho Falls, Idaho, United States

Research Site

Stony Brook, New York, United States

Research Site

Providence, Rhode Island, United States

Research Site

Mt. Pleasant, South Carolina, United States

Research Site

Leuven, , Belgium

Research Site

Belo Horizonte, , Brazil

Research Site

Frankfurt am Main, , Germany

Research Site

Southampton, , United Kingdom

Countries

United States; Belgium; Brazil; Germany; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

2021-006056-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D8850C00006

Identifier Type: -

Identifier Source: org_study_id