Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sars Cov 2
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 80 years
- Gender
- Both males and females
Description
This is a phase 2a, open-label study enrolling up to 106 healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will enter this study approximately 3 months after their final study visit in the Parent Study. Participants that received placebo in the Parent Study or wh...
This is a phase 2a, open-label study enrolling up to 106 healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will enter this study approximately 3 months after their final study visit in the Parent Study. Participants that received placebo in the Parent Study or who are seronegative for SARS-CoV-2 neutralizing antibodies at screening will receive a single dose of ARCT-021 and will be followed for 365 days. Participants that received two injections of ARCT-021 in the Parent Study will not receive any further injections of ARCT-021 and will be followed for 281 days.
Tracking Information
- NCT #
- NCT04728347
- Collaborators
- Not Provided
- Investigators
- Not Provided
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