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

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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

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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