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

NCT04625725 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: D8850C000022020-004356-16
• Study Type: interventional
• Target: 5,197
• Locations: 5 countries
• Sites: 89

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.

Conditions

COVID-19

Keywords

Pre-exposure Prophylaxis of COVID-19

Outcome Measures

Primary Outcomes (2)

• Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness

  To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 prior to Day 183. Planned to be evaluated through Day 183, however, the number of events required for the primary endpoint was achieved 165 days after the study start date which is displayed in the primary efficacy row below. Final analysis is final data from the study based on the pre-planned 183 days of follow up for this endpoint.

  165 Days for primary analysis, 183 days for final analysis

• AEs, SAEs, MAAEs, and AESIs Post Dose of IMP

  To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo

  457 Days, Final analysis

Secondary Outcomes (5)

• The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARS-CoV-2 Nucleocapsid Antibodies.

  366 days

• The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP

  366 Days

• The Incidence of COVID-19-related Emergency Department Visits Occurring After Dosing With IMP

  366 days

• Serum AZD7442 Concentrations, PK Parameters if Data Permit.

  457 days

• Incidence of ADA to AZD7442 in Serum

  457 days

Other Outcomes (1)

• AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis

  165 Days

Study Arms (5)

AZD7442

EXPERIMENTAL

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

Drug: AZD7442

Placebo

PLACEBO COMPARATOR

Approximately 5150 participants will be randomized in a 2:1 ratio • Arm 2 (n=approximately 1717) will receive saline placebo

Drug: Placebo

Sub-study AZD7442 Arm 1

EXPERIMENTAL

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.

Drug: AZD7442

Sub-study AZD7442 Arm 2

EXPERIMENTAL

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.

Drug: AZD7442

Sub-study AZD7442 Arm 3

EXPERIMENTAL

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.

Drug: AZD7442

Interventions

AZD7442 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

Also known as: Combination of 2mAbs(AZD8895 and AZD1061)

AZD7442; Sub-study AZD7442 Arm 1; Sub-study AZD7442 Arm 2; Sub-study AZD7442 Arm 3

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age at the time of signing the informed consent
• Can benefit from passive immunization with antibodies
• Medically stable
• Negative result from point of care SARS-CoV-2 serology testing at screening
• Contraceptive used by women of child bearing potential, condom used by men
• 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:
• Immunocompromised and/or may be at increased risk for an inadequate immune response to a COVID-19 vaccine.
• 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.

You may not qualify if:

• Significant infection or other acute illness, including fever \>100°F (\>37.8°C) on the day prior to or day of randomization.
• History of laboratory-confirmed SARS-CoV-2 infection or any positive SARS-CoV-2 result based on available data at screening.
• History of infection with severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS).
• Known history of allergy or reaction to any component of the study drug formulation.
• Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of a mAb.
• 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.
• Bleeding disorder or prior history of significant bleeding or bruising following IM injections or venepuncture.
• 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.
• 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
• Currently pregnant or breastfeeding.
• Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.
• 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.
• 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.
• 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).
• Patient have two or more untreated cardiac risk factors or suspected unstable cardiac disease.

Sponsors & Collaborators

• AstraZeneca: lead
• Iqvia Pty Ltd: collaborator

Study Sites (89)

Research Site

Birmingham, Alabama, 35215, United States

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Tempe, Arizona, 85284, United States

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Little Rock, Arkansas, 72205, United States

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Cerritos, California, 90703, United States

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Fresno, California, 93720, United States

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Garden Grove, California, 92844, United States

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Huntington Beach, California, 92647, United States

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Lancaster, California, 93534, United States

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Modesto, California, 95350, United States

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Victorville, California, 92394, United States

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Westminster, California, 92683, United States

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Hartford, Connecticut, 06112, United States

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Middlebury, Connecticut, 06762, United States

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Clearwater, Florida, 33756, United States

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Coral Springs, Florida, 33071, United States

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Hollywood, Florida, 33024, United States

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Lauderdale Lakes, Florida, 33313, United States

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Miami, Florida, 33125, United States

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Ormond Beach, Florida, 32174, United States

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Pompano Beach, Florida, 33064, United States

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Wesley Chapel, Florida, 33545, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30328, United States

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Columbus, Georgia, 31904, United States

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Conyers, Georgia, 30094, United States

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Marietta, Georgia, 30060, United States

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Honolulu, Hawaii, 96859, United States

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Chicago, Illinois, 60607, United States

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Hazel Crest, Illinois, 60429, United States

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Quincy, Illinois, 62301, United States

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Evansville, Indiana, 47714, United States

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Noblesville, Indiana, 46060, United States

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Wichita, Kansas, 67205, United States

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Wichita, Kansas, 67214, United States

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Minneapolis, Minnesota, 55404, United States

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Minneapolis, Minnesota, 55435, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68134, United States

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Las Vegas, Nevada, 89128, United States

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Albuquerque, New Mexico, 87109, United States

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Jamaica, New York, 11432, United States

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Ridgewood, New York, 11385, United States

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The Bronx, New York, 10461, United States

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Greensboro, North Carolina, 27410, United States

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Columbus, Ohio, 43213, United States

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Oklahoma City, Oklahoma, 73104, United States

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Summerville, South Carolina, 29485, United States

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Rapid City, South Dakota, 57701, United States

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Austin, Texas, 78751, United States

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El Paso, Texas, 79925, United States

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El Paso, Texas, 79935, United States

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Houston, Texas, 77054, United States

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San Antonio, Texas, 78215, United States

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San Antonio, Texas, 78251, United States

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Shenandoah, Texas, 77384, United States

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Sugar Land, Texas, 77479, United States

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Layton, Utah, 84041, United States

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Alexandria, Virginia, 22304, United States

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Chesapeake, Virginia, 23320, United States

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Tacoma, Washington, 98402, United States

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Alken, 3570, Belgium

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Brussels, 1000, Belgium

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Gozée, 6534, Belgium

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Namur, 5101, Belgium

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Wetteren, 9230, Belgium

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Clermont-Ferrand, 63003, France

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Dijon, 21079, France

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La Roche S/ Yon Cedex 9, 85925, France

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Lille, 59037, France

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Limoges, 87000, France

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Nantes, 44093, France

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Paris, 75475, France

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Paris, 75679, France

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Saint-Etienne, 42055, France

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Tours, 37044, France

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Barcelona, 08036, Spain

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Madrid, 28034, Spain

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Madrid, 28040, Spain

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Marbella (Málaga), 29603, Spain

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Pozuelo de Alarcón, 28223, Spain

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Bournemouth, BH7 7DW, United Kingdom

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Enfield, EN3 4GS, United Kingdom

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Hayle, TR27 5DT, United Kingdom

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London, WC1N 3BG, United Kingdom

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Preston, PR1 6YA, United Kingdom

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Rochdale, OL11 4AU, United Kingdom

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Salford, M6 8HD, United Kingdom

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Torpoint, PL11 2TB, United Kingdom

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Wakefield, WF1 5RH, United Kingdom

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Related Links

• CSP redacted
• SAP redacted
• CSR synopsis redacted

MeSH Terms

Conditions

COVID-19

Interventions

cilgavimab and tixagevimab drug combination; cilgavimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Myron Levin, MD

  AstraZeneca

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 12, 2020
• Study Start: November 21, 2020
• Primary Completion: August 16, 2022
• Study Completion: December 8, 2023
• Last Updated: December 31, 2024
• Results First Posted: December 20, 2022

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

GB (9); BE (5); FR (10); ES (5); US (60)