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

NCT04625972

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: COVID-19

Interventions: AZD7442, Placebo

Countries: United States, United Kingdom

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

Eligibility overview

Sex: ALL

Age: 18 Years to 120 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (57)

Guntersville, Alabama, United States
Tempe, Arizona, United States
Little Rock, Arkansas, United States
Bakersfield, California, United States
Corona, California, United States
Garden Grove, California, United States
Huntington Beach, California, United States
Huntington Park, California, United States
Modesto, California, United States
Coral Gables, Florida, United States
Coral Springs, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
Miami Springs, Florida, United States
Mt. Dora, Florida, United States
North Miami, Florida, United States
Pembroke Pines, Florida, United States
Pompano Beach, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Buford, Georgia, United States
Conyers, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Hazel Crest, Illinois, United States
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