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

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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

Key facts

Study ID

NCT04625972

Run by

AstraZeneca

People needed

1131

Starts

2020-12-02

Expected to finish

2022-07-25

Last updated by the study team

2023-11-21

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• History of laboratory-confirmed SARS-CoV-2 infection or SARS-CoV-2 seropositivity 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.
• Clinically significant bleeding disorder or prior history of significant bleeding or bruising following IM injections or venipuncture.
• 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.
• 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 breast feeding.
• 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.

Where it is running

• 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, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, 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 — Mt. 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 — Guntersville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.