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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-29

Study Completion Date

2024-05-17

Brief Summary

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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

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Detailed Description

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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.

Conditions

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COVID-19, SARS-CoV-2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Single dose of Placebo IM (0.9% sodium chloride)

Group Type PLACEBO_COMPARATOR

Biological: Placebo

Intervention Type BIOLOGICAL

Single dose of Placebo IM (0.9% sodium chloride)

AZD3152

Single dose of 300 mg IM

Group Type EXPERIMENTAL

Biological: AZD3152

Intervention Type BIOLOGICAL

300 mg single dose of AZD3152 IM

Interventions

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Biological: AZD3152

300 mg single dose of AZD3152 IM

Intervention Type BIOLOGICAL

Biological: Placebo

Single dose of Placebo IM (0.9% sodium chloride)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No