This study will assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19 in Adults.
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.
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.
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.
Research Site
Guntersville, Alabama, United States
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Tempe, Arizona, United States
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Little Rock, Arkansas, United States
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Bakersfield, California, United States
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Corona, California, United States
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Garden Grove, California, United States
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Huntington Beach, California, United States
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Huntington Park, California, United States
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Modesto, California, United States
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Coral Gables, Florida, United States
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Coral Springs, Florida, United States
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Miami Lakes, Florida, United States
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Miami Lakes, Florida, United States
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Miami Springs, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Mount Dora, Florida, United States
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North Miami, Florida, United States
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Pembroke Pines, Florida, United States
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Pompano Beach, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Buford, Georgia, United States
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Conyers, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Hazel Crest, Illinois, United States
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Noblesville, Indiana, United States
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West Des Moines, Iowa, United States
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Wichita, Kansas, United States
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Owensboro, Kentucky, United States
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Bethesda, Maryland, United States
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High Point, North Carolina, United States
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Wilmington, North Carolina, United States
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Orangeburg, South Carolina, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Friendswood, Texas, United States
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Gonzales, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Riverton, Utah, United States
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Alexandria, Virginia, United States
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Portsmouth, Virginia, United States
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Richmond, Virginia, United States
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Tacoma, Washington, United States
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Bournemouth, United Kingdom
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Hayle, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Southampton, United Kingdom
Myron Levin, MD, Principal Investigator
AstraZeneca