Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study - SUPERNOVA

Study identifier:D7000C00001

ClinicalTrials.gov identifier:NCT05648110

EudraCT identifier:2022-002378-95

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants with Conditions Causing Immune Impairment. Sub-study: Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19

Medical condition

COVID-19, SARS-CoV-2

Phase

Phase 2/3

Healthy volunteers

Yes

Study drug

-

Sex

All

Actual Enrollment

3882

Study type

Interventional

Age

12 Years - n/a

Date

Study Start Date: 16 Dec 2022
Primary Completion Date: 07 Sept 2023
Estimated Study Completion Date: 31 Jan 2025

Study design

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

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria