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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

NCT06057064•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must be 18 years of age or older at the time of signing the informed consent.
•Weight ≥ 45 kg at Visit 1.
•Participants must satisfy at least 1 of the following risk factors at enrollment:
•1. Obese, ie, BMI ≥ 30
•2. Congestive heart failure
•3. Chronic obstructive pulmonary disease
•4. Chronic kidney disease
•5. Intolerant of vaccine
•6. Immunocompromised state (one of the following risk factors ):
•1. Have cancer
+7 more criteria

Exclusion Criteria

•Known hypersensitivity to any component of the study intervention
•Previous hypersensitivity or severe adverse reaction following administration of a mAb
•Acute or febrile infection prior to dosing
•Has HIV infection
•Receipt of any convalescent COVID-19 plasma treatment, mAb against SARS-CoV-2 , COVID-19 vaccine within 6 months
•COVID-19 antiviral prophylaxis within at least 2 weeks
•COVID-19 case within 6 months

Locations (6)

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Saint Petersburg, Russia

Key Dates

Start Date

September 29, 2023

Primary Completion Date

May 17, 2024

Completion Date

May 17, 2024

Last Updated

August 15, 2025

Enrollment

116

ACTUAL participants

Conditions

COVID-19, SARS-CoV-2

Interventions

Biological: AZD3152

BIOLOGICAL

Biological: Placebo

BIOLOGICAL

Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

NCT06160128

COVID-19, SARS-CoV-2 InfectionRSV+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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