NCT06057064

Study Will Assess the Safety, Neutralizing Activity and Efficacy of AZD3152 in Adults With Conditions Increasing Risk of Inadequate Protective Immune Response After Vaccination and Thus Are at High Risk of Developing Severe COVID-19

A Phase II Randomized, Double-blind Study to Evaluate the Safety, Neutralizing Activity and Efficacy of AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants Having an Increased Risk for Inadequate Response to Active Immunization (NOVELLA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19. The aim of the Phase II study is to evaluate the safety, neutralizing activity and efficacy of AZD3152 for pre exposure prophylaxis of COVID-19

Detailed description

Phase II study to assess the safety, neutralizing activity and efficacy of one dose of AZD3152 compared with one dose of placebo in adults with immunocompromised conditions, including comorbidities contributing to weakened immunity, thereby increasing the risk of COVID-19 progression up to severe grade.

Conditions

• COVID-19, SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	Biological: AZD3152	300 mg single dose of AZD3152 IM
BIOLOGICAL	Biological: Placebo	Single dose of Placebo IM (0.9% sodium chloride)

Timeline

• Start date: 2023-09-29
• Primary completion: 2024-05-17
• Completion: 2024-05-17
• First posted: 2023-09-28
• Last updated: 2025-08-15
• Results posted: 2025-08-15

Locations

6 sites across 1 country: Russia