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

NCT04516746 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32450

Last updated 2024-02-05

Study results available
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Summary

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

Conditions

Interventions

BIOLOGICAL

AZD1222

AZD1222 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2-5 surface glycoprotein.

BIOLOGICAL

Placebo

Commercially available 0.9% (n/V) saline for injection.

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Ann Falsey, MD · University of Rochester

  • Magda Sobieszczyk, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2021-03-05
Completion
2023-02-10
FDA Drug
Yes

Countries

  • United States
  • Chile
  • Peru

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04516746 on ClinicalTrials.gov