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AZD7442 for Pediatric COVID-19 (TRUST Trial)
TRUST Trial Summary
This trial will study how AZD7442 works in children, how safe it is, and how well tolerated it is.
TRUST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTRUST Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 1131 Patients • NCT04625972TRUST Trial Design
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Who is running the clinical trial?
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- I have received COVID-19 plasma or hyperimmune globulin therapy before.I started my treatment within 7 days of noticing my first symptom.I haven't had COVID-19 symptoms in the 10 days before joining the study.I am at high risk for severe COVID-19 due to a weakened immune system or other health conditions.I am at high risk for severe COVID-19 due to a weakened immune system or other health conditions.I do not need immediate medical attention or hospitalization.This is a group of participants in the study that meet certain criteria.I need a ventilator or ECMO due to COVID-19.I haven't taken any experimental drugs or used experimental devices in the last 30 days or 5 half-lives of the drug.I have received or will receive a COVID-19 monoclonal antibody or biologic treatment.I was hospitalized for COVID-19 and treated within 7 days of my first symptoms.My condition has been stable without needing major treatment changes or hospital visits for a month.My condition has been stable without needing major treatment changes or hospital visits for a month.I have had SARS or MERS in the past.I haven't had a significant infection or fever just before receiving AZD7442.I will get AZD7442 as a shot unless I have severe COVID-19, bleeding issues, or my doctor prefers IV.I don't need urgent surgery nor have life-threatening conditions recently.I am at high risk for severe COVID-19 due to a weakened immune system or other health conditions.I am between 29 weeks of pregnancy and under 18 years old.I weigh at least 1.5 kg.I haven't had a COVID-19 vaccine within 14 days of screening or plan to get one within 14 days after the first study visit.I am between 29 weeks of pregnancy and under 18 years old.My condition has been stable without needing major treatment changes or hospital visits for a month.You have a higher chance of getting infected with the virus that causes COVID-19.
- Group 1: AZD7442
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the age cutoff for participation in this clinical trial extend below 35 years?
"This research requires participants of the age range between 0 and 17 years. Currently, 31 trials are seeking younger individuals while 155 studies require patients aged 65 or higher."
How many health care facilities are currently hosting this trial?
"This investigation is taking place in 14 locations across the United States, including Miami, Long Beach and Providence. For those interested in participating, selecting a location near to you can reduce the travel burden associated with the trial's requirements."
What requirements must patients meet to qualify for this exploration?
"This trial seeks to recruit 100 paediatric patients aged between 0-17 years old with COVID-19. The eligibility criteria includes: a minimum gestational age of 29 weeks, body weight of 1.5kg or more, an immunocompromised state or one/multiple comorbidities that increase the risk for severe coronavirus disease 2019 (COVID-19), heightened vulnerability to SARS-CoV‑2 infection, medically stable condition in preceding month prior to enrollment, negative RT‑PCR test collected 3 days preceeding Day 1 OR a negative rapid SARS‑CoV‑2 antigen test at"
Could you discuss the potential hazards associated with AZD7442?
"AZD7442 obtained a score of 1 on the safety scale due to its limited clinical data in Phase 1, indicating that its efficacy and security are yet to be comprehensively evaluated."
What is the current enrollment for this research endeavor?
"Affirmative. According to clinicaltrials.gov, this investigation is open for recruitment and has been since March 21st 2022, with the latest update on November 14th of that year. A total of 100 volunteers are sought after in 14 specific locations."
What are the primary goals of this research endeavor?
"The central aim of this trial, which will span from Day 1 to Day 366, is the assessment of AZD7442's serum concentrations through modelling. Secondary objectives include measuring the proportion of participants that progress with COVID-19 after a single dose in Cohort 2 and 3 (Treatment), assessing SARS-CoV-2 infections incidence among those receiving prophylaxis in Cohort 1 and monitoring post-dosing mortality rates due to COVID-19 across 90 days for both Treatment cohorts."
Is this research endeavor accessible to participants at present?
"According to the information provided on clinicaltrials.gov, this trial is currently in search of participants. It was initially listed on March 21st 2022 and its most recent update was November 14th 2022."
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