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

NCT ID: NCT04625725

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 5197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-21
• Study Completion Date: 2023-12-08

Brief 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.

Detailed Description

SARS-CoV-2 is the causative agent of the ongoing COVID-19 pandemic that, as of 29 September 2020, has resulted in a high death toll to date. Unlike the majority of coronaviruses that cause mild disease in humans and animals, SARS-CoV-2 can replicate in the lower respiratory tract to cause acute respiratory distress syndrome and fatal pneumonia. Effective interventions to prevent or treat COVID-19 remain limited in number and clinical experience is limited. Clinical management is limited to supportive care, consequently overwhelming resources of healthcare systems around the world. As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 S protein. The SARS-CoV-2 spike protein contains the virus's RBD, which enables the virus to bind to receptors on human cells. By targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, is expected to block infection. Amino acid substitutions have been introduced into the antibodies to both extend their half-lives, which should prolong their potential prophylactic benefit, and decrease Fc effector function in order to decrease the potential risk of antibody-dependent enhancement of disease. AZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration to prevent and/or treat COVID-19. There is currently one completed and 2 ongoing Phase I studies with AZD7442.

-The Provent repeat dose open-label sub-study is initiated to assess the safety, PK and immunogenicity of repeat doses of AZD7442 in participants currently enrolled in the Provent study who may benefit from repeat dose of AZD7442.

Conditions

COVID-19

Keywords

Pre-exposure Prophylaxis of COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

AZD7442

Approximately 5150 participants will be randomized in a 2:1 ratio

• Arm 1 (n=approximately 3433) will receive a single dose (× 2IM injections) of 300 mg of AZD7442

Group Type: EXPERIMENTAL

AZD7442

Intervention Type: DRUG

• 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

Placebo

Approximately 5150 participants will be randomized in a 2:1 ratio

• Arm 2 (n=approximately 1717) will receive saline placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Sub-study AZD7442 Arm 1

Approximately 500 participants will receive AZD7442 in the repeat dose sub-study.

-Sub-study Arm 1 (~ 12 month repeat dose interval): Participants who received AZD7442 300 mg IM on Day 1 of the parent study will receive a second dose of AZD7442 300mg IM on sub-study Day 1.

Group Type: EXPERIMENTAL

AZD7442

Intervention Type: DRUG

• 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

Sub-study AZD7442 Arm 2

Approximately 500 participants will receive AZD7442 in the repeat dose sub-study.

-Sub-study Arm 2(~ 6 month repeat dose interval): Participants who received placebo on Day 1 of the parent study will receive their first dose of AZD7442 300mg IM on sub-study Day1 followed by a second dose on sub-study Day 183.

Group Type: EXPERIMENTAL

AZD7442

Intervention Type: DRUG

• 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

Sub-study AZD7442 Arm 3

A subset of Arm 1 and Arm 2 participants who will receive additional doses of AZD7442, 600mg, at Day 183 and Day 366 of the sub-study.

Group Type: EXPERIMENTAL

AZD7442

Intervention Type: DRUG

• 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

Interventions

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Combination of 2mAbs(AZD8895 and AZD1061)

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 years of age at the time of signing the informed consent

2. Can benefit from passive immunization with antibodies

3. Medically stable

4. Negative result from point of care SARS-CoV-2 serology testing at screening

5. Contraceptive used by women of child bearing potential, condom used by men

6. Able to understand and comply with study requirements/procedures based on the assessment of the investigator

• The participant has been randomized, dosed, and is ongoing in the PROVENT parent study and is 12±2 months post first dose of blinded IMP.
• If one or more of the following apply:

1. Immunocompromised and/or may be at increased risk for an inadequate immune response to a COVID-19 vaccine.

2. In the opinion of the Investigator, are at increased risk and would benefit from a repeat dose of AZD7442.

• Documented negative SARS-CoV-2 RT-PCR test collected ≤ 3 days prior to sub-study Day 1 or a negative rapid SARS-CoV-2 antigen test at screening.

Exclusion Criteria

1. Significant infection or other acute illness, including fever >100°F (>37.8°C) on the day prior to or day of randomization.

2. History of laboratory-confirmed SARS-CoV-2 infection or any positive SARS-CoV-2 result based on available data at screening.

3. History of infection with severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS).

4. Known history of allergy or reaction to any component of the study drug formulation.

5. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of a mAb.

6. Any prior receipt of investigational or licensed vaccine or other mAb/biologic indicated for the prevention of SARS-CoV-2 or COVID-19 or expected receipt during the period of study follow-up.

7. Bleeding disorder or prior history of significant bleeding or bruising following IM injections or venepuncture.

8. Any other significant disease, disorder, or finding. that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data.

9. Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study

10. Currently pregnant or breastfeeding.

11. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.

12. Employees of the Sponsor involved in planning, executing, supervising, or reviewing the AZD7442 program,, clinical study site staff, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.

13. In nations, states, or other jurisdictions that for legal or ethical reasons bar the enrollment of participants who lack capacity to provide their own informed consent, such subjects are excluded.

1. Patient have received a COVID-19 vaccination ≤ 14 days before sub-study Day1 or plan to receive a COVID-19 vaccination ≤ 14 days after sub-study Day1. (Such participants can subsequently be included in the study once they have reached >14 days after their last dose of vaccine).

2. Patient have two or more untreated cardiac risk factors or suspected unstable cardiac disease.

3. Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iqvia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myron Levin, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca

Locations

Research Site

Birmingham, Alabama, United States

Research Site

Tempe, Arizona, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Cerritos, California, United States

Research Site

Fresno, California, United States

Research Site

Garden Grove, California, United States

Research Site

Huntington Beach, California, United States

Research Site

Lancaster, California, United States

Research Site

Modesto, California, United States

Research Site

Victorville, California, United States

Research Site

Westminster, California, United States

Research Site

Hartford, Connecticut, United States

Research Site

Middlebury, Connecticut, United States

Research Site

Clearwater, Florida, United States

Research Site

Coral Springs, Florida, United States

Research Site

Hollywood, Florida, United States

Research Site

Lauderdale Lakes, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Ormond Beach, Florida, United States

Research Site

Pompano Beach, Florida, United States

Research Site

Wesley Chapel, Florida, United States

Research Site

West Palm Beach, Florida, United States

Research Site

Atlanta, Georgia, United States

Research Site

Columbus, Georgia, United States

Research Site

Conyers, Georgia, United States

Research Site

Marietta, Georgia, United States

Research Site

Honolulu, Hawaii, United States

Research Site

Chicago, Illinois, United States

Research Site

Hazel Crest, Illinois, United States

Research Site

Quincy, Illinois, United States

Research Site

Evansville, Indiana, United States

Research Site

Noblesville, Indiana, United States

Research Site

Wichita, Kansas, United States

Research Site

Wichita, Kansas, United States

Research Site

Minneapolis, Minnesota, United States

Research Site

Minneapolis, Minnesota, United States

Research Site

St Louis, Missouri, United States

Research Site

Omaha, Nebraska, United States

Research Site

Las Vegas, Nevada, United States

Research Site

Albuquerque, New Mexico, United States

Research Site

Jamaica, New York, United States

Research Site

Ridgewood, New York, United States

Research Site

The Bronx, New York, United States

Research Site

Greensboro, North Carolina, United States

Research Site

Columbus, Ohio, United States

Research Site

Oklahoma City, Oklahoma, United States

Research Site

Summerville, South Carolina, United States

Research Site

Rapid City, South Dakota, United States

Research Site

Austin, Texas, United States

Research Site

El Paso, Texas, United States

Research Site

El Paso, Texas, United States

Research Site

Houston, Texas, United States

Research Site

San Antonio, Texas, United States

Research Site

San Antonio, Texas, United States

Research Site

Shenandoah, Texas, United States

Research Site

Sugar Land, Texas, United States

Research Site

Layton, Utah, United States

Research Site

Alexandria, Virginia, United States

Research Site

Chesapeake, Virginia, United States

Research Site

Tacoma, Washington, United States

Research Site

Alken, , Belgium

Research Site

Brussels, , Belgium

Research Site

Gozée, , Belgium

Research Site

Namur, , Belgium

Research Site

Wetteren, , Belgium

Research Site

Clermont-Ferrand, , France

Research Site

Dijon, , France

Research Site

La Roche S/ Yon Cedex 9, , France

Research Site

Lille, , France

Research Site

Limoges, , France

Research Site

Nantes, , France

Research Site

Paris, , France

Research Site

Paris, , France

Research Site

Saint-Etienne, , France

Research Site

Tours, , France

Research Site

Barcelona, , Spain

Research Site

Madrid, , Spain

Research Site

Madrid, , Spain

Research Site

Marbella (Málaga), , Spain

Research Site

Pozuelo de Alarcón, , Spain

Research Site

Bournemouth, , United Kingdom

Research Site

Enfield, , United Kingdom

Research Site

Hayle, , United Kingdom

Research Site

London, , United Kingdom

Research Site

Preston, , United Kingdom

Research Site

Rochdale, , United Kingdom

Research Site

Salford, , United Kingdom

Research Site

Torpoint, , United Kingdom

Research Site

Wakefield, , United Kingdom

Countries

United States; Belgium; France; Spain; United Kingdom

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

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Other Identifiers

2020-004356-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D8850C00002

Identifier Type: -

Identifier Source: org_study_id