Official Title
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
Brief Summary

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

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.

Completed
COVID-19

Drug: AZD7442

Single dose (× 2 IM injections) of 300 mg of AZD7442 on Day 1.
Other Name: A combination of 2 mAbs (AZD8895 and AZD1061)

Drug: Placebo

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

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 120 Years
Countries
United Kingdom
United States
Locations

Research Site
Guntersville, Alabama, United States

Research Site
Tempe, Arizona, United States

Research Site
Little Rock, Arkansas, United States

Research Site
Bakersfield, California, United States

Research Site
Corona, California, United States

Research Site
Garden Grove, California, United States

Research Site
Huntington Beach, California, United States

Research Site
Huntington Park, California, United States

Research Site
Modesto, California, United States

Research Site
Coral Gables, Florida, United States

Research Site
Coral Springs, Florida, United States

Research Site
Miami Lakes, Florida, United States

Research Site
Miami Lakes, Florida, United States

Research Site
Miami Springs, Florida, United States

Research Site
Miami, Florida, United States

Research Site
Miami, Florida, United States

Research Site
Miami, Florida, United States

Research Site
Miami, Florida, United States

Research Site
Mount Dora, Florida, United States

Research Site
North Miami, Florida, United States

Research Site
Pembroke Pines, Florida, United States

Research Site
Pompano Beach, Florida, United States

Research Site
Tampa, Florida, United States

Research Site
West Palm Beach, Florida, United States

Research Site
Atlanta, Georgia, United States

Research Site
Buford, Georgia, United States

Research Site
Conyers, Georgia, United States

Research Site
Chicago, Illinois, United States

Research Site
Chicago, Illinois, United States

Research Site
Hazel Crest, Illinois, United States

Research Site
Noblesville, Indiana, United States

Research Site
West Des Moines, Iowa, United States

Research Site
Wichita, Kansas, United States

Research Site
Owensboro, Kentucky, United States

Research Site
Bethesda, Maryland, United States

Research Site
High Point, North Carolina, United States

Research Site
Wilmington, North Carolina, United States

Research Site
Orangeburg, South Carolina, United States

Research Site
Dallas, Texas, United States

Research Site
El Paso, Texas, United States

Research Site
Friendswood, Texas, United States

Research Site
Gonzales, Texas, United States

Research Site
Harlingen, Texas, United States

Research Site
Houston, Texas, United States

Research Site
San Antonio, Texas, United States

Research Site
Riverton, Utah, United States

Research Site
Alexandria, Virginia, United States

Research Site
Portsmouth, Virginia, United States

Research Site
Richmond, Virginia, United States

Research Site
Tacoma, Washington, United States

Research Site
Bournemouth, United Kingdom

Research Site
Hayle, United Kingdom

Research Site
London, United Kingdom

Research Site
London, United Kingdom

Research Site
London, United Kingdom

Research Site
Manchester, United Kingdom

Research Site
Southampton, United Kingdom

Myron Levin, MD, Principal Investigator
AstraZeneca

Iqvia Pty Ltd
NCT Number
Keywords
Post exposure COVID-19
MeSH Terms
COVID-19
Cilgavimab and tixagevimab drug combination