Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults
Condition: COVID-19
MeSH terms: COVID-19
Intervention: AZD7442; Placebo
Intervention description: Single dose (× 2 IM injections) of 300 mg of AZD7442 on Day 1.; Single dose (× 2 IM injections) of saline placebo on Day 1.
Intervention MeSH terms: Cilgavimab and tixagevimab drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1131.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Post exposure COVID-19

Summary:

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

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.