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

Phase 2

Completed

• Conditions: COVID-19, SARS-CoV-2

• Registration Number: NCT06057064
• Lead Sponsor: AstraZeneca

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

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.

Study Timeline

• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-09-28
• Study Start: 2023-09-29
• Status Verified: 2024-05
• Primary Completion: 2024-05-17
• Study Completion: 2024-05-17
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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
     2. Have solid organ transplant or a hematopoietic stem cell transplant
     3. Are actively taking immunosuppressive medicines
     4. Received chimeric antigen receptor T-cell therapy
     5. Within 1 year of receiving B-cell depleting therapies
     6. Have a moderate or severe primary immunodeficiency

• Medically stable

• WOCBP must not be pregnant or lactating and must use a highly effective method of contraception

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The number and proportion of subjects with AEs, SAEs, MAAEs, AESIs.	up to Day 181	The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data

Secondary Outcome Measures

Name	Time	Method
Geometric mean titer (GMT) and geometric mean fold rise (GMFRs)	up to Day 181	NAbs response will be evaluated based on nAbs titer to the SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study
incidence of a post-treatment symptomatic COVID-19 case	up to Day 181	Incidence of a post-treatment symptomatic COVID-19 case (negative RT-PCR at baseline to positive RT-PCR or positive antigen test at any time up to 6 months AND symptoms specified in the modified WHO definition of symptomatic COVID-19).

Trial Locations

Locations (1)

Research Site; 🇷🇺 St Petersburg, Russian Federation