Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
COVID-19, SARS-CoV-2
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
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...
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 co...
Eligibility Criteria
Inclusion
- 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
- Medically stable
- WOCBP must not be pregnant or lactating and must use a highly effective method of contraception
Exclusion
- 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
Key Trial Info
Start Date :
September 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2024
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06057064
Start Date
September 29 2023
End Date
May 17 2024
Last Update
August 15 2025
Active Locations (6)
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1
Research Site
Moscow, Russia, 115478
2
Research Site
Moscow, Russia, 115522
3
Research Site
Moscow, Russia, 123182
4
Research Site
Moscow, Russia, 125284