Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.
Condition: COVID-19
MeSH terms: COVID-19
Intervention: AZD7442; Placebo
Intervention description: Single dose (× 2IM injections) of 300 mg of AZD7442 on parent study Day 1.
Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 1.
Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 183.
Single dose (x 2IM injections) of 600mg of AZD7442 on sub-study Day 183 and Day 366; Single dose (× 2IM injections) of saline placebo on parent study 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: 5254.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Pre-exposure Prophylaxis of COVID-19

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.
    

Eligibility 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

        Sub-study Inclusion criteria which are additional to those in parent study are as follows:

          -  The participant has been randomized, dosed, and is ongoing in the PROVENT parent study
             and is 12±2 months post first dose of blinded IMP.

          -  If one or more of the following apply:

               1. Immunocompromised and/or may be at increased risk for an inadequate immune
                  response to a COVID-19 vaccine.

               2. In the opinion of the Investigator, are at increased risk and would benefit from
                  a repeat dose of AZD7442.

          -  Documented negative SARS-CoV-2 RT-PCR test collected ≤ 3 days prior to sub-study Day 1
             or a negative rapid SARS-CoV-2 antigen test at screening.

        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.

        Sub-study Exclusion criteria are as follows:

          1. Patient have received a COVID-19 vaccination ≤ 14 days before sub-study Day1 or plan
             to receive a COVID-19 vaccination ≤ 14 days after sub-study Day1. (Such participants
             can subsequently be included in the study once they have reached >14 days after their
             last dose of vaccine).

          2. Patient have two or more untreated cardiac risk factors or suspected unstable cardiac
             disease.

          3. Judgment by the Investigator that the participant should not participate in the study
             if the participant is unlikely to comply with study procedures, restrictions, and
             requirements.