A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19

PHASE2TerminatedINTERVENTIONAL
Enrollment

251

Participants

Timeline

Start Date

June 9, 2022

Primary Completion Date

October 4, 2023

Study Completion Date

October 4, 2023

Conditions
Coronavirus Disease 2019 (COVID-19)
Interventions
BIOLOGICAL

AZD7442 (tixagevimab [AZD8895] + cilgavimab [AZD1061])

"Arm A - Day 1:~600 mg AZD7442 administered sequentially as a 3 mL IM injection containing 300 mg tixagevimab (AZD8895) and a 3 mL IM injection containing 300 mg cilgavimab (AZD1061), one injection in each gluteal region.~Arm A - Days 92, 183, 274, 365:~300 mg AZD7442 administered sequentially as a 1.5 mL IM injection containing 150 mg tixagevimab (AZD8895) and a 1.5 mL IM injection containing 150 mg cilgavimab (AZD1061), one injection in each gluteal region."

BIOLOGICAL

AZD7442 (tixagevimab [AZD8895] + cilgavimab [AZD1061])

"Arm B - Day 1:~1200 mg AZD7442 (600 mg tixagevimab \[AZD8895\] and 600 mg cilgavimab \[AZD1061\]) administered by IV infusion.~Arm B - Days 183, 365:~600 mg AZD7442 administered sequentially as a 3 mL IM injection containing 300 mg tixagevimab (AZD8895) and a 3 mL IM injection containing 300 mg cilgavimab (AZD1061), one injection in each gluteal region."

Trial Locations (16)

22003

Research Site, Annandale

32055

Research Site, Lake City

32174

Research Site, Ormond Beach

33014

Research Site, Miami Lakes

33024

Research Site, Hollywood

33125

Research Site, Miami

33409

Research Site, West Palm Beach

33545

Research Site, Wesley Chapel

35215

Research Site, Birmingham

37920

Research Site, Knoxville

60640

Research Site, Chicago

63141

Research Site, St Louis

78745

Research Site, Austin

79925

Research Site, El Paso

92683

Research Site, Westminster

95350

Research Site, Modesto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY