Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study

Exclusion Criteria

• •Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration.
• •Known hypersensitivity to any component of the study intervention.
• •Previous hypersensitivity or severe adverse reaction following administration of a mAb.
• •Acute (time-limited) or febrile (temperature ≥ 38.0°C \[100.4ºF\]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the screening period or may be rescreened once.
• •Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
• •Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
• •Receipt of immunoglobulin (non-COVID related) or blood products within 6 months prior to Visit 1.
• •Previous receipt of a mAb against SARS-CoV-2.
• •Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
• •Receipt of a COVID-19 antiviral for prophylaxis within 3 months prior to Visit 1
• •COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test \[including at home testing\]).
• •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.
• •Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
• •Active infection with hepatitis B or C.
• •Serum creatinine, AST, or ALT above 1.5 × ULN at screening
• •History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years.
• •Parent study - Main Cohort Participants (Phase III):
• •Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration. Note: female participants aged \> 12 years will be considered to be a woman of childbearing potential.
• •Known hypersensitivity to any component of the study intervention.
• •Previous hypersensitivity or severe adverse reaction following administration of a mAb.
• •Acute (time-limited) or febrile (temperature ≥ 38.0°C \[100.4ºF\]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves and may be rescreened for enrollment once.
• •Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
• •Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
• •Receipt of IV or SC immunoglobulin within 6 months prior to Visit 1 or expected to receive IV or SC immunoglobulin 6 months after dosing.
• •Receipt of convalescent COVID-19 plasma treatment within 6 months prior to Visit 1.
• •Previous receipt of a mAb against SARS-CoV-2 within 6 months prior to Visit 1.
• •Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
• •Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1.
• •COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test \[including at home testing\]).
• •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 except where the participant ceased IMP treatment \>90 days and is in the follow-up period of the study and not expected to receive further IMP).
• •Active infection with hepatitis B or C.
• •Serum creatinine, AST, or ALT above 1.5 × ULN at screening.
• •History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years.
• •Receipt of EVUSHELD (AZD7442) within 12 months prior to Visit 1.
• •Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration. Note: female participants aged \> 12 years will be considered to be a woman of childbearing potential.
• •Known hypersensitivity to any component of the study intervention.
• •Previous hypersensitivity or severe adverse reaction following administration of a mAb.
• •Acute (time-limited) or febrile (temperature ≥ 38.0°C \[100.4ºF\]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves and may be rescreened for enrollment once.
• •Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
• •Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
• •Has human immunodeficiency virus infection.
• •Receipt of IV or SC immunoglobulin or blood products within 6 months prior to Visit 1 and expected to receive IV or SC immunoglobulin or blood products 6 months after dosing.
• •Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
• •Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1.
• •COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory RT-PCR testing or a rapid antigen test \[including at-home testing\]).
• •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 (except where the participant ceased IMP treatment \> 90 days and is in the follow-up period of the study and not expected to receive further IMP).