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 - NOVELLA

Study identifier:AZ-RU-00002

ClinicalTrials.gov identifier:NCT06057064

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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)

Medical condition

COVID-19, SARS-CoV-2

Phase

Phase 2

Healthy volunteers

No

Study drug

-

Sex

All

Actual Enrollment

116

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 29 Sept 2023
Primary Completion Date: 17 May 2024
Study Completion Date: 17 May 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria