Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.

• Status: Active, not recruiting
• Trial end date: 2022-06-29
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborators: Iqvia Pty Ltd; QuintilesIMS

Criteria

Inclusion Criteria:

1. ≥ 18 years of age at the time of signing the informed consent

2. Can benefit from passive immunization with antibodies

3. Medically stable

4. Negative result from point of care SARS-CoV-2 serology testing at screening

5. Contraceptive used by women of child bearing potential, condom used by men

6. Able to understand and comply with study requirements/procedures based on the assessment of the investigator

Exclusion Criteria:

1. Significant infection or other acute illness, including fever >100°F (>37.8°C) on the day prior to or day of randomization.

2. History of laboratory-confirmed SARS-CoV-2 infection or any positive SARS-CoV-2 result based on available data at screening.

3. History of infection with severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS).

4. Known history of allergy or reaction to any component of the study drug formulation.

5. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of a mAb.

6. 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.

7. Bleeding disorder or prior history of significant bleeding or bruising following IM injections or venepuncture.

8. Any other significant disease, disorder, or finding. that 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.

9. 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

10. Currently pregnant or breastfeeding.

11. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.

12. 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.

13. 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.