Study identifier:AZ-RU-00002
ClinicalTrials.gov identifier:NCT06057064
EudraCT identifier:N/A
CTIS identifier:N/A
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)
COVID-19, SARS-CoV-2
Phase 2
No
-
All
116
Interventional
18 Years - 99 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
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
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.
Location
Location
Moscow, Russian Federation, 125284
Location
St Petersburg, Russian Federation, 197341
Location
Moscow, Russian Federation, 142770
Location
Moscow, Russian Federation, 123182
Location
Moscow, Russian Federation, 115522
Location
Moscow, Russian Federation, 115478
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo Single dose of Placebo IM (0.9% sodium chloride) | Biological/Vaccine: Biological: Placebo Single dose of Placebo IM (0.9% sodium chloride) |
Experimental: AZD3152 Single dose of 300 mg IM | Biological/Vaccine: Biological: AZD3152 300 mg single dose of AZD3152 IM |
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