The TRUST Study

Trust Study

Summary

The purpose of the study is to learn more about an experimental drug called AZD7442 (the ‘study drug’) and to find out if it may help prevent and treat COVID-19 at its associated health problems in children and adolescents. ‘Experimental’ means that the drug is being used in research studies like this and we continue learning about the drug efficacy, effects and safety of it

Duration of study

Maximum of 479 days.

Sponsor and Funder

AstraZeneca AB

Population (age group)

≥ 29 weeks Gestational age to < 18 years of age at the time of signing the informed consent.

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

Open to recruitment: Open to recruitment

Aim of the study: The purpose of this study is to learn more about an experimental drug called AZD7442 (the ‘study drug’) and to find out if it may help prevent and treat COVID-19 and its associated health problems in children and adolescents.

Inclusion criteria:

  • Participants have an underlying condition that increases their risk of developing severe COVID-19 if they become infected; or,
  • Participants have an underlying condition and have already been infected with the virus that causes COVID-19 (severe acute respiratory syndrome coronavirus 2, or (SARS-CoV-2).

What participating in the study involves:

Your child is expected to be in the study for a maximum of 479 days.

Your child will need to undergo a series of tests within 7 days before being given AZD7442. This is called screening. Participants must meet all inclusion criteria (study entry requirements). Children and adolescents participating in the trial for prevention of COVID-19, or for treatment of mild-moderate COVID-19, must have a medical condition that puts them at increased risk of severe COVID-19. Infants must weigh at least 1.5 kg (3 lbs 5 oz) at screening to qualify for this study.

If your child meets the screening criteria for study participation, they will be given a single dose of AZD7442 and monitored for up to 15 months. If your child doesn’t meet the screening criteria, the reasons will be explained. Your study doctor will talk to you and your child about other possible treatments.

Want to know more about the study?

Find more information about the study on the Participant Information Sheet