Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: COVID-19; SARS-CoV-2

Treatments: Biological: AZD1222; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04516746

2020-005226-28 (EudraCT Number)

D8110C00001

Details and patient eligibility

About

The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19.

Full 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.

Enrollment: 32,450 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

32,450 participants in 2 patient groups, including a placebo group

AZD1222

Experimental group

Description:

Approximately 20,000 participants randomized to the AZD1222 arm

Treatment:

Biological: AZD1222

Placebo

Placebo Comparator group

Description:

Approximately 10,000 participants randomized to the saline placebo arm

Treatment:

Biological: Placebo