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Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.

NCT04625725 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5197

Last updated 2024-12-31

Study results available
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Summary

This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.

Conditions

Interventions

DRUG

AZD7442

* Single dose (× 2IM injections) of 300 mg of AZD7442 on parent study Day 1. * Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 1. * Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 183. * Single dose (x 2IM injections) of 600mg of AZD7442 on sub-study Day 183 and Day 366

DRUG

Placebo

Single dose (× 2IM injections) of saline placebo on parent study Day 1.

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Myron Levin, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-21
Primary Completion
2022-08-16
Completion
2023-12-08
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Spain
  • United Kingdom

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 NCT04625725 on ClinicalTrials.gov