At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 116 enrolled
Drug / intervention
Biological: AZD3152 +1 morebiological
Likely dose
Biological: AZD3152 300 mgfrom record
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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)
In Brief
A Phase 2 clinical trial evaluating Biological: AZD3152 and Biological: Placebo for COVID-19, SARS-CoV-2. Completed, enrolled 116 participants across 6 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19, SARS-CoV-2
CountriesRussia
Collaborators--
Timeline
Phase 2CompletedFinished
202420252026
First PostedSep 2023
Enrollment StartSep 2023
Primary CompletionMay 2024
TodayJul 2026
First PostedSep 28, 2023
Enrollment StartSep 29, 2023
Primary CompletionMay 17, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.8 years ago
Interventions
Biological: AZD3152biological
300 mg single dose of AZD3152 IM
Biological: Placebobiological
Single dose of Placebo IM (0.9% sodium chloride)