NCT05375760

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

A Phase II Randomized, Open-label, Multicenter, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, a Combination Product of Two Monoclonal Antibodies (Tixagevimab and Cilgavimab), for Pre-exposure Prophylaxis of COVID-19

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

A Phase II Randomized, Open-label, Multicenter, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, a Combination Product of Two Monoclonal Antibodies (Tixagevimab and Cilgavimab), for Pre-exposure Prophylaxis of COVID-19

Detailed description

AZD7442, a combination of 2 monoclonal antibodies (tixagevimab \[investigational name, AZD8895\] and cilgavimab \[investigational name, AZD1061\]), is being developed for the prophylaxis and treatment of coronavirus disease 2019 (COVID-19). This Phase II dose-ranging study will investigate the safety, immunogenicity, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of AZD7442 repeat dosing regimens for preexposure prophylaxis of COVID-19 in adults and pediatric individuals (≥ 12 years of age weighing at least 40 kg), who are moderately to severely immunocompromised.

Conditions

• Coronavirus Disease 2019 (COVID-19)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-09
• Primary completion: 2023-10-04
• Completion: 2023-10-04
• First posted: 2022-05-17
• Last updated: 2024-10-23
• Results posted: 2024-10-23

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study