| Eligibility |
Inclusion Criteria:
1. Capable of giving signed informed consent as described in Appendix A which includes
compliance with the requirements and restrictions listed in the ICF and in this protocol.
For pediatric participants: informed assent is to be provided by the participant; informed
consent must be provided by the participant's legal guardian 2. Ensure that participants
who are considered by the Investigator clinically unable to consent at screening and who
are entered into the study by the consent of a legally acceptable representative show
evidence of assent, as applicable in accordance with local regulations.
3. Participant must be an adult (= 18 years of age) or pediatric individual (= 12 to < 18
years of age weighing = 40 kg) at the time of signing the ICF or assent (for pediatric
participants).
4. Individuals with medical conditions or treatments that may result in moderate to severe
immune compromise or an inadequate immune response to COVID-19 vaccination include but are
not limited to:
1. Active treatment for solid tumor and hematologic malignancies.
2. Receipt of solid-organ transplant and taking immunosuppressive therapy.
3. Receipt of chimeric antigen receptor T-cell or hematopoietic stem cell transplant
(within 2 years of transplantation or taking immunosuppression therapy).
4. Moderate or severe primary immunodeficiency (eg, DiGeorge syndrome, Wiskott-Aldrich
syndrome).
5. Advanced or untreated HIV infection (people with HIV and history of CD4 cellcounts <
200/mm3, history of an AIDS-defining illness without immune reconstitution, or
clinical manifestations of symptomatic HIV).
6. Active treatment with systemic high-dose corticosteroids (ie, = 20 mg prednisone or
equivalent per day when administered for = 2 weeks), alkylating agents,
antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic
agents classified as severely immunosuppressive, tumor necrosis factor blockers, and
other biologic agents that are immunosuppressive or immunomodulatory (eg, B-cell
depleting agents).
5 Documented negative SARS-CoV-2 RT-PCR test from an NP specimen collected = 3 days
prior to Day 1 or a negative SARS-CoV-2 rapid antigen test from an NP specimen at
screening.
Exclusion Criteria:
1. Any clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough,
dyspnea, sore throat, fatigue for = 5 days or confirmed COVID-19 infection by
appropriate laboratory test within 28 days prior to screening. Prior COVID-19
infection is not an exclusion.
2. History or current hospitalization for worsening disease during the one month
prior to screening, with no change in condition at the time of study enrollment
as judged by the Investigator.
3. Current need for hospitalization or immediate medical attention in a clinic or
emergency room service in the clinical opinion of the Investigator.
4. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction
following administration of a mAb.
5. Known history of allergy to any component of the IMP formulation.
6. History of clinically significant bleeding disorder (eg, factor deficiency,
coagulopathy, or platelet disorder), or prior history of significant bleeding or
bruising following IV infusions or venepuncture.
7. 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
8. Any co-morbidity requiring surgery within 7 days prior to study entry, or that is
considered life-threatening in the opinion of the Investigator within 30 days
prior to study entry.
9 Any prior receipt of investigational or licensed mAb or other biologic indicated for
the prevention or treatment of SARS-CoV-2 or COVID-19 within 5 half-lives prior to
screening or expected administration immediately after enrollment.
10 Have received a COVID-19 vaccination = 14 days before Day 1 or plan to receive a
COVID-19 vaccination = 14 days after Day 1 (Such participants can subsequently be
included in the study once they have reached > 14 days after their last dose of
vaccine).
11 Receipt of convalescent COVID-19 plasma treatment within 90 days prior to
screening.
12 Receipt of any IMP in the preceding 90 days or 5 half-lives, whichever is longer,
or expected receipt of IMP during the period of study follow-up, or concurrent
participation in another interventional study.
13 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.
14 For women only - currently pregnant (confirmed with positive pregnancy test) or
breastfeeding.
15 Previous randomization in the present study. 16 Blood drawn in excess of a total of
450 mL (1 unit) for any reason within 30 days prior to randomization.
17 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.
18 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.
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