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

NCT06057064 | Completed Phase 2 Results

• 1 other identifier: AZ-RU-00002
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

COVID-19, SARS-CoV-2

Keywords

Pre-exposure Prophylaxis of COVID-19

Outcome Measures

Primary Outcomes (1)

• The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs.

  The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data

  up to Day 181

Secondary Outcomes (3)

• Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)

  up to Day 181

• Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s)

  up to Day 181

• Incidence of a Post-treatment Symptomatic COVID-19 Case

  up to Day 181

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Single dose of Placebo IM (0.9% sodium chloride)

Biological: Biological: Placebo

AZD3152

EXPERIMENTAL

Single dose of 300 mg IM

Biological: Biological: AZD3152

Interventions

Biological: AZD3152 BIOLOGICAL

300 mg single dose of AZD3152 IM

AZD3152

Biological: Placebo BIOLOGICAL

Single dose of Placebo IM (0.9% sodium chloride)

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Obese, ie, BMI ≥ 30
• Congestive heart failure
• Chronic obstructive pulmonary disease
• Chronic kidney disease
• Intolerant of vaccine
• Immunocompromised state (one of the following risk factors ):
• Have cancer
• Have solid organ transplant or a hematopoietic stem cell transplant
• Are actively taking immunosuppressive medicines
• Received chimeric antigen receptor T-cell therapy
• Within 1 year of receiving B-cell depleting therapies
• Have a moderate or severe primary immunodeficiency

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Moscow, 115478, Russia

Location

Research Site

Moscow, 115522, Russia

Location

Research Site

Moscow, 123182, Russia

Location

Research Site

Moscow, 125284, Russia

Location

Research Site

Moscow, 142770, Russia

Location

Research Site

Saint Petersburg, 197341, Russia

Location

Related Links

• Redacted CSP
• Redacted CSR Synopsis
• Redacted SAP

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

\[Not Specified\]

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is 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 adult participants. Approximately 116 participants in Russia will be randomized at up to 10 study sites in a ratio of 3:1 to either AZD3152 or placebo administered IM.

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: September 28, 2023
• Study Start: September 29, 2023
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: August 15, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. All the data will be provided in blinded manner until final unblinded data analysis will be completed. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

RU (6)