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

Exclusion Criteria

• • Previous hypersensitivity or severe adverse reaction following administration of a mAb.
• • 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 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.
• For Main Cohort Participants (Phase III)
• Inclusion Criteria
• • Participant must be 12 years of age or older at the time of signing the informed consent.
• • Negative rapid antigen test at Visit 1.
• • Participants must satisfy at least 1 of the following risk factors at enrollment:
• o Have cancer (eg, active solid tumors and hematologic malignancies) except for adequately treated:
• 1. Non-melanoma skin cancer or lentigo maligna
• 2. Uterine cervical carcinoma in situ
• 3. Local prostate carcinoma
• o Have solid organ transplant or a hematopoietic stem cell transplant (within 2 years of transplantation, are taking immunosuppression therapy or who have chronic graft versus-host disease)
• o Are actively taking immunosuppressive medicines (eg, are using corticosteroids [ie, ≥ 20 mg prednisone or equivalent per day when administered for ≥ 2 weeks], high dose alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive [eg, Bruton’s tyrosine kinase inhibitors], tumor-necrosis blockers, or other immunosuppressive or immunomodulatory biologic agents for rheumatic diseases)
• o Received chimeric antigen receptor T cell therapy
• o Within 1 year of receiving B-cell depleting therapies (eg, rituximab, ocrelizumab, ofatumumab, alemtuzumab)
• o Have a moderate or severe primary immunodeficiency (eg, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe combined immunodeficiency, common variable immunodeficiency, agammaglobulinemia)
• • Medically stable defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 1 month prior to enrollment, with no acute change in condition at the time of study enrollment as judged by the Investigator and no expected changes at the time of the enrollment.
• Exclusion Criteria
• • Previous hypersensitivity or severe adverse reaction following administration of a mAb.
• • Has HIV infection.
• • 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 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]).