Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA)
- Conditions
- COVID-19MedDRA version: 23.0Level: PTClassification code: 10051905Term: Coronavirus infection Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2024-512554-15-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3349
Sentinel Safety Cohort: Healthy participants according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the investigator, with no concomitant disease or concomitant medication (except for medication specifically permitted by the protocol), Main Cohort: Weight = 40 kg at screening, Main Cohort: Participants must satisfy at least 1 of the following risk factors at enrollment: •Have solid tumor cancer and be on active immunosuppressive treatment •Have hematologic malignancy •Transplant participants must satisfy at least one of the following: - Have had a solid organ transplant within 2 years and / or - Had a hematopoietic stem cell transplant within 2 years and / or - Who have chronic graft-versus-host disease - Participants who previously had a solid organ transplant or hematopoietic stem cell transplant more than 2 years prior to Visit 1 may also be eligible based on the inclusion criterion for immunosuppressive treatment. •Are actively taking immunosuppressive medicines (eg, are using 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 [eg,Bruton's tyrosine kinase inhibitors], tumor-necrosis blockers, or other immunosuppressive biologic agents (eg, for rheumatic diseases) •Received chimeric antigen receptor T cell therapy •Within 1 year of receiving B-cell depleting therapies (eg, rituximab, ocrelizumab, ofatumumab, alemtuzumab) •Have a moderate or severe primary (eg, DiGeorge syndrome) or secondary (eg, hemodialysis) immunodeficiency • Advanced or untreated HIV infection (people with HIV and CD4 cell counts < 200/mm3 within 6 months of Visit 1, history of an AIDSdefining illness without immune reconstitution, or clinical manifestations of symptomatic HIV), Main Cohort: Medically stable defined as disease not requiring significant change in maintenance therapy or hospitalization for worsening disease or any recent CV event (eg, acute myocardial infarction, thromboembolic event) 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., Main Cohort: Able to understand and comply with all study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined), including those at Illness Visits, based on the assessment of the Investigator., Sentinel Safety Cohort: Age 18 to 55 years at the time of signing the informed consent, Sentinel Safety Cohort: Written informed consent and any locally required authorization (eg, HIPAA in the US) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations., Sentinel Safety Cohort: Negative rapid antigen test at Visit 1, Sentinel Safety Cohort: Weight = 45 kg and = 110 kg at screening., Sentinel Safety Cohort: Able to understand and comply with all study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined) based on the assessment of the Investigator., Main Cohort: Participant must be 12 years of age or older at the time of signing the
Sentinel Safety Cohort: 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, (see details in CSP)., Sentinel Safety Cohort: Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1, Sentinel Safety Cohort: COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at home testing]), Sentinel Safety Cohort: 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., Main Cohort: 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 (see details in CSP)., Main Cohort: Known hypersensitivity to any component of the study intervention., Main Cohort: Previous hypersensitivity or severe adverse reaction following administration of a mAb, Main Cohort: Acute (time-limited) or febrile (temperature = 38.0°C 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., Main Cohort: Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1., Main Cohort: Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture., Main Cohort: 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., Sentinel Safety Cohort: Known hypersensitivity to any component of the study intervention., Main Cohort: Receipt of convalescent COVID-19 plasma treatment within 6 months prior to Visit 1., Main Cohort: Previous receipt of a mAb against SARS-CoV-2 within 6 months prior to Visit 1., Main Cohort: Receipt of a COVID-19 vaccine within 3 months prior to Visit 1., Main Cohort: Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1., Main Cohort: COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at-home testing])., Main Cohort: 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)., Main Cohort: Alcohol or substance abuse that, in the opinion of the Investigator, might interfere with the trial conduct or completion., Main Cohort: Deprived of freedom by an administrative or court order, or in emergency setting, or hospitalized involuntarily., Main Cohort: Any condition that, in the opinion of the Investigator, might compromise participant safety or interfere with evaluation of the study intervention or interpretation of participant safety or st
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method