*TRUST
Research type
Research Study
Full 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
IRAS ID
1004564
Contact name
Solange Rohou
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-006056-13
Clinicaltrials.gov Identifier
Research summary
As a response to the ongoing COVID-19 pandemic, AstraZeneca has developed monoclonal antibodies (mAbs) targeting the SARS-CoV-2 spike protein and thus providing passive immunization to neutralize the virus. AZD7442 consists of 2 separate mAbs which bind to distinct, non-overlapping sites on the SARS-CoV-2 spike protein. Binding to either of these sites blocks virus entry, effectively neutralizing the SARS-CoV-2 virus. By blocking virus entry into human cells, AZD7442 stops virus replication, which stops infection, and is, therefore, being developed for the prevention and treatment of COVID-19.
Up to 3 cohorts of participants will be enrolled based on the adult indication and dose: 1) participants who are SARS-CoV-2 negative at screening and have not knowingly been exposed to a SARS-CoV-2 positive individual (pre-exposure prophylaxis); 2) participants who are SARS-CoV-2 positive at screening and have mild to moderate coronavirus disease 2019 (COVID 19) symptoms; and 3) participants who are SARS-CoV-2 positive at screening and have severe COVID-19. Both Cohorts 1 and Cohort 2 are required to be at increased risk of developing severe COVID-19.
Eligible participants will receive one single dose of IM or IV AZD7442 based on the participant’s body weight. Investigational medicinal product will be administered on Day 1, and participants will be monitored for up to 15 months after AZD7442 administration.
Approximately 120 participants will be enrolled worldwide such that a minimum of 100 evaluable participants are assigned to study intervention and complete the study. Recruitment will be stratified to ensure that all pediatric age groups are represented.
This study is being sponsored by AstraZeneca AB.REC name
London - Hampstead Research Ethics Committee
REC reference
22/FT/0075
Date of REC Opinion
24 May 2022
REC opinion
Further Information Favourable Opinion