Ended Therapeutic confirmatory (Phase III) COVID-19

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

EU CTIS ID: 2024-512554-15-00

What this study is testing

Main Cohort 1.To evaluate the safety of AZD3152 and EVUSHELD and/or placebo 2. To compare the efficacy of AZD3152 to EVUSHELD and/or placebo in the prevention of symptomatic COVID-19 caused by any SARS CoV 2 variant 3. To compare the efficacy of AZD3152 to EVUSHELD and/or placebo in the prevention of symptomatic COVID-19 attributable to matched variants (variants that do not contain the F456L mutation) Sentinel Safety Cohort 1.To evaluate the safety of AZD5156

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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

You likely can't join if

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.

See the full eligibility criteria

Who can join

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 informed consent.
Main 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. For participants from 12 to < 18 years of age, their parents or legal guardians must give their signed written informed consent, as appropriate, and participants will sign an assent form.
Main Cohort: Negative rapid antigen test prior to dosing at Visit 1.

What rules you out

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 study results.
Main Cohort: Employees of AstraZeneca involved in planning, executing, supervising, or reviewing the AZD5156/AZD3152 program, clinical study site staff, or any other individuals involved with the conduct of the study, or family members of such individuals.
Sentinel Safety Cohort: Previous hypersensitivity or severe adverse reaction following administration of a mAb.
Sentinel Safety 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.
Sentinel Safety Cohort: Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
Sentinel Safety 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.
Sentinel Safety Cohort: Receipt of immunoglobulin (non-COVID related) or blood products within 6 months prior to Visit 1
Sentinel Safety Cohort: Previous receipt of a mAb against SARS-CoV-2
Sentinel Safety Cohort: Receipt of a COVID-19 vaccine within 3 months prior to Visit 1

The study team makes the final eligibility decision.

Where it's taking place

United Arab Emirates
Canada
Korea, Republic of
Australia
Singapore
United Kingdom
Malaysia
Taiwan
Israel
United States
Vietnam
Thailand

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Arab Emirates; Canada; Korea, Republic of; Australia; Singapore; United Kingdom and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.