Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults (STORM CHASER)

November 17, 2023 updated by: AstraZeneca

A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Post-exposure Prophylaxis of COVID-19

This study will assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19 in Adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 ongoing Phase I study with AZD7442.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Research Site
      • Hayle, United Kingdom, TR27 5DT
        • Research Site
      • London, United Kingdom, EC1A 7BE
        • Research Site
      • London, United Kingdom, SE5 8AZ
        • Research Site
      • London, United Kingdom, WC1E 6ER
        • Research Site
      • Manchester, United Kingdom, M8 5RB
        • Research Site
      • Southampton, United Kingdom, SO16 6YD
        • Research Site
  • United States
    • Alabama
      • Guntersville, Alabama, United States, 35976
        • Research Site
    • Arizona
      • Tempe, Arizona, United States, 85284
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Bakersfield, California, United States, 93309
        • Research Site
      • Corona, California, United States, 92882
        • Research Site
      • Garden Grove, California, United States, 92844
        • Research Site
      • Huntington Beach, California, United States, 92647
        • Research Site
      • Huntington Park, California, United States, 90255
        • Research Site
      • Modesto, California, United States, 95350
        • Research Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Research Site
      • Coral Springs, Florida, United States, 33071
        • Research Site
      • Miami, Florida, United States, 33175
        • Research Site
      • Miami, Florida, United States, 33125
        • Research Site
      • Miami, Florida, United States, 33155
        • Research Site
      • Miami, Florida, United States, 33256
        • Research Site
      • Miami Lakes, Florida, United States, 33014
        • Research Site
      • Miami Lakes, Florida, United States, 33016
        • Research Site
      • Miami Springs, Florida, United States, 33166
        • Research Site
      • Mount Dora, Florida, United States, 32757
        • Research Site
      • North Miami, Florida, United States, 33161
        • Research Site
      • Pembroke Pines, Florida, United States, 33024
        • Research Site
      • Pompano Beach, Florida, United States, 33064
        • Research Site
      • Tampa, Florida, United States, 33603
        • Research Site
      • West Palm Beach, Florida, United States, 33409
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Research Site
      • Buford, Georgia, United States, 30519
        • Research Site
      • Conyers, Georgia, United States, 30094
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Research Site
      • Chicago, Illinois, United States, 60640
        • Research Site
      • Hazel Crest, Illinois, United States, 60429-2196
        • Research Site
    • Indiana
      • Noblesville, Indiana, United States, 46060
        • Research Site
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Research Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Research Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Research Site
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Research Site
      • El Paso, Texas, United States, 79930
        • Research Site
      • Friendswood, Texas, United States, 77546
        • Research Site
      • Gonzales, Texas, United States, 78629
        • Research Site
      • Harlingen, Texas, United States, 78550
        • Research Site
      • Houston, Texas, United States, 77099
        • Research Site
      • San Antonio, Texas, United States, 78215
        • Research Site
    • Utah
      • Riverton, Utah, United States, 84096
        • Research Site
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • Research Site
      • Portsmouth, Virginia, United States, 23708
        • Research Site
      • Richmond, Virginia, United States, 23226
        • Research Site
    • Washington
      • Tacoma, Washington, United States, 98402
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥ 18 years of age at the time of signing the informed consent
  2. Adults with potential exposure, within 8 days, to a specific identified individual with laboratory-confirmed SARS-COV-2 infection, symptomatic or asymptomatic
  3. Participants must not have had COVID-19 symptoms within 10 days of dosing
  4. Negative result from point of care SARS-CoV-2 serology test at screening
  5. Contraception used by women of childbearing potential, condom by men
  6. Able to understand and comply with study requirements/procedures based on the assessment of the investigator

Exclusion Criteria:

  1. History of laboratory-confirmed SARS-CoV-2 infection or SARS-CoV-2 seropositivity at screening.
  2. History of infection with severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS).
  3. Known history of allergy or reaction to any component of the study drug formulation.
  4. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of a mAb.
  5. 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.
  6. Clinically significant bleeding disorder or prior history of significant bleeding or bruising following IM injections or venipuncture.
  7. Any other significant disease, disorder, or finding that, in the judgement of the investigator, 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.
  8. 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.
  9. Currently pregnant or breast feeding.
  10. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.
  11. 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.
  12. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AZD7442
Participants will be randomized in a 2:1 ratio to receive a single dose (× 2 IM injections) of either 300 mg of AZD7442 (n = approximately 750) or saline placebo (n = approximately 375) on Day 1.
Drug: AZD7442
Single dose (× 2 IM injections) of 300 mg of AZD7442 on Day 1.
Other Names:
  • A combination of 2 mAbs (AZD8895 and AZD1061)
Placebo Comparator: Placebo
Participants will be randomized in a 2:1 ratio to receive a single dose (× 2 IM injections) of either 300 mg of AZD7442 (n = approximately 750) or saline placebo (n = approximately 375) on Day 1.
Drug: Placebo
Single dose (× 2 IM injections) of saline placebo on Day 1.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness
Time Frame: Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start date
To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19
Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start date
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
Time Frame: 457 Days
457 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP
Time Frame: 183 Days
183 Days
The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARSCoV- 2 Nucleocapsid Antibodies
Time Frame: 366 Days
366 Days
The Incidence of COVID-19-related Death Occurring After Dosing With IMP
Time Frame: 366 Days
366 Days
The Incidence of All-cause Mortality Occurring After Dosing With IMP
Time Frame: 366 Days
366 Days
Serum AZD7442 Concentrations, PK Parameters
Time Frame: 457 Days
457 Days
Incidence of ADA to AZD7442 in Serum
Time Frame: 457 Days
457 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IQVIA Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Myron Levin, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 7, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D8850C00003
  • 2020-004719-28 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing 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

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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