Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults
Purpose
The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19.
Conditions
- COVID-19
- SARS-CoV-2
Eligibility
- Eligible Ages
- Between 18 Years and 130 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Increased risk of SARS-CoV-2 infection - Medically stable
Exclusion Criteria
- confirmed or suspected immunosuppressive or immunodeficient state - significant disease, disorder, or finding - Prior or concomitant vaccine therapy for COVID-19
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants are assigned to one of two or more groups in parallel for the duration of the study.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Double Blind: two or more parties are unaware of the intervention assignment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AZD1222 |
Approximately 20,000 participants randomized to the AZD1222 arm |
|
|
Placebo Comparator Placebo |
Approximately 10,000 participants randomized to the saline placebo arm |
|
Recruiting Locations
More Details
- NCT ID
- NCT04516746
- Status
- Completed
- Sponsor
- AstraZeneca
Detailed Description
The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no specific treatments available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID-19 prevention would have significant public health impact.