CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 46 enrolled
Drug / intervention
AZD7442drug
Likely dose
Not stated in record
Key inclusion· 11
  • ✓Age ≥29 weeks gestational age to <18 years
  • ✓Minimum weight 1.5 kg
  • ✓Cohort 1: High risk of severe COVID-19 (immunocompromised or comorbidities)
  • ✓Cohort 1: Negative RT-PCR or antigen test within 3 days of dosing
Key exclusion· 11
  • ✕Active infection or acute illness with fever on or day prior to dosing (Cohort 1)
  • ✕History of SARS-CoV-1 or MERS-CoV infection
  • ✕Current need for hospitalization (Cohorts 1-2)
  • ✕Requiring mechanical ventilation or ECMO for COVID-19

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05281601
NCT05281601Phase 1Completed
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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

AstraZeneca·interventional·Posted Mar 16, 2022·Updated Apr 18, 2025

In Brief

A Phase 1 clinical trial evaluating AZD7442 for SARS-CoV-2. Completed, enrolled 46 participants across 11 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2
CountriesBelgium, Brazil, Germany, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedMar 16, 2022
Enrollment StartMar 21, 2022
Primary CompletionApr 16, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.3 years ago

Interventions

AZD7442drug

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.