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

ArmDescriptionAssigned Intervention
Experimental
AZD1222 		Approximately 20,000 participants randomized to the AZD1222 arm
  • Biological: AZD1222
    AZD1222 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2-5 surface glycoprotein.
Placebo Comparator
Placebo 		Approximately 10,000 participants randomized to the saline placebo arm
  • Biological: Placebo
    Commercially available 0.9% (n/V) saline for injection.

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.