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

April 16, 2024 updated by: AstraZeneca

A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants With Conditions Causing Immune Impairment. Sub-study: Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19

AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.

The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061.

Sub-study:

This Phase II sub-study of SUPERNOVA will assess the safety, PK, and predicted neutralizing activity of AZD3152 compared with EVUSHELD for pre-exposure prophylaxis of COVID-19.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

In the Parent study, the Phase I Sentinel Safety Cohort will assess the safety of AZD5156 (a combination of 2 mAbs, AZD1061 [cilgavimab, a component of AZD7442 (EVUSHELD)] and AZD3152) in healthy adults and the Phase III Main Cohort will assess the safety, efficacy, PK, and neutralizing activity of two doses of AZD3152 compared with two doses of comparator given at a 6-month interval in adults and adolescents 12 years of age or older (weighing at least 40 kg) with conditions causing immune impairment, who are less likely to mount an adequate protective immune response after vaccination and thus are at higher risk of developing severe COVID-19 in 18 countries.

Sub-study:

This Phase II sub-study of SUPERNOVA is operating in USA only, and it will assess the safety, PK, and predicted neutralizing activity of AZD3152 in adults 18 years of age or older (weighing at least 40 kg) with conditions causing immune impairment who are less likely to mount an adequate protective immune response after vaccination as well as individuals who are immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.

Study Type

Interventional

Enrollment (Actual)

3882

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3004
        • Research Site
      • Melbourne, Australia, 3000
        • Research Site
      • Murdoch, Australia, 6150
        • Research Site
      • Parkville, Australia, 3050
        • Research Site
      • Raymond Terrace, Australia, 4101
        • Research Site
      • Sippy Downs, Australia, 4556
        • Research Site
      • West Perth, Australia, 6005
        • Research Site
  • Belgium
      • Alken, Belgium, 3570
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
      • Montreal, Quebec, Canada, H2X 0A9
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9100
        • Research Site
      • Aarhus, Denmark, 8200
        • Research Site
      • Hvidovre, Denmark, 2650
        • Research Site
      • Roskilde, Denmark, 4000
        • Research Site
      • Svendborg, Denmark, DK-5700
        • Research Site
  • France
      • Dijon Cedex, France, 21079
        • Research Site
      • La Roche sur Yon, France, 85925
        • Research Site
      • Lille, France, 59037
        • Research Site
      • Nantes, France, 44093
        • Research Site
      • Nîmes Cedex 9, France, 30029
        • Research Site
      • Paris, France, 75014
        • Research Site
      • Paris cedex 10, France, 75475
        • Research Site
      • Poitiers, France, 86000
        • Research Site
      • Saint-Etienne Cedex 2, France, 42055
        • Research Site
      • Strasbourg, France, 67091
        • Research Site
      • Toulouse Cedex 9, France, 31059
        • Research Site
      • Tours, France, 37000
        • Research Site
  • Germany
      • Essen, Germany, 45147
        • Research Site
      • Hamburg, Germany, 20095
        • Research Site
      • Hannover, Germany, 30625
        • Research Site
      • Köln, Germany, 50924
        • Research Site
      • Mainz, Germany, 55131
        • Research Site
  • Israel
      • Petah Tikva, Israel, 49100
        • Research Site
      • Ramat Gan, Israel, 52621
        • Research Site
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 13620
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Research Site
      • Seoul, Korea, Republic of, 08308
        • Research Site
      • Seoul, Korea, Republic of, 5505
        • Research Site
  • Malaysia
      • Bandar Sunway, Malaysia, 47500
        • Research Site
      • Kuala Lumpur, Malaysia, 59100
        • Research Site
      • Kuala Lumpur, Malaysia, 56000
        • Research Site
      • Kuching, Malaysia, 93586
        • Research Site
      • Seberang Jaya, Malaysia, 13700
        • Research Site
  • Poland
      • Krakow, Poland, 30-727
        • Research Site
      • Skórzewo, Poland, 60-185
        • Research Site
  • Singapore
      • Singapore, Singapore, 169608
        • Research Site
      • Singapore, Singapore, 117599
        • Research Site
      • Singapore, Singapore, 308442
        • Research Site
  • Spain
      • Badalona, Spain, 08916
        • Research Site
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 08036
        • Research Site
      • Barcelona, Spain, 08041
        • Research Site
      • Cordoba, Spain, 14004
        • Research Site
      • Madrid, Spain, 28031
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Marbella (Málaga), Spain, 29603
        • Research Site
      • Mérida, Spain, 06800
        • Research Site
      • Pozuelo de Alarcón, Spain, 28223
        • Research Site
      • Valladolid, Spain, 47003
        • Research Site
      • Vigo, Spain, 36312
        • Research Site
  • Taiwan
      • Taichung, Taiwan, 40447
        • Research Site
      • Taipei, Taiwan, 11490
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Research Site
      • Bangkok, Thailand, 10700
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
      • Muang, Thailand, 50200
        • Research Site
      • Muang, Thailand, 11000
        • Research Site
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 2951
        • Research Site
      • Abu Dhabi, United Arab Emirates, 34555
        • Research Site
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Research Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Research Site
      • Harrow, United Kingdom, HA1 3UJ
        • Research Site
      • Leeds, United Kingdom, LS9 7TF
        • Research Site
      • Liverpool, United Kingdom, L7 8XP
        • Research Site
      • London, United Kingdom, SE1 7EH
        • Research Site
      • London, United Kingdom, W1T 7HA
        • Research Site
      • Manchester, United Kingdom, M8 5RB
        • Research Site
      • Oxford, United Kingdom, OX3 7LA
        • Research Site
      • Sheffield, United Kingdom, S10 2JF
        • Research Site
      • Torpoint, United Kingdom, PL11 2TB
        • Research Site
      • Truro, United Kingdom, TR1 3LJ
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Research Site
      • Birmingham, Alabama, United States, 35215
        • Research Site
      • Mobile, Alabama, United States, 36608
        • Research Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Research Site
      • Mesa, Arizona, United States, 85206
        • Research Site
      • Mesa, Arizona, United States, 85210
        • Research Site
      • Tucson, Arizona, United States, 85712
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Colton, California, United States, 92324
        • Research Site
      • La Mesa, California, United States, 91942
        • Research Site
      • Long Beach, California, United States, 90815
        • Research Site
      • Los Angeles, California, United States, 90027
        • Research Site
      • Modesto, California, United States, 95350
        • Research Site
      • Sacramento, California, United States, 95817
        • Research Site
      • Tustin, California, United States, 92780
        • Research Site
      • Westminster, California, United States, 92683
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Research Site
      • Denver, Colorado, United States, 80246
        • Research Site
      • Denver, Colorado, United States, 80209
        • Research Site
      • Fort Collins, Colorado, United States, 80525
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Research Site
      • Fleming Island, Florida, United States, 32003
        • Research Site
      • Fort Myers, Florida, United States, 33912
        • Research Site
      • Hollywood, Florida, United States, 33024
        • Research Site
      • Jacksonville, Florida, United States, 32256
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Lake Worth, Florida, United States, 33462
        • Research Site
      • Lauderdale Lakes, Florida, United States, 33313
        • Research Site
      • Leesburg, Florida, United States, 34748
        • Research Site
      • Medley, Florida, United States, 33166
        • Research Site
      • Miami, Florida, United States, 33126
        • Research Site
      • Miami, Florida, United States, 33186
        • Research Site
      • Miami, Florida, United States, 33125
        • Research Site
      • Miami, Florida, United States, 33135
        • Research Site
      • Miami Lakes, Florida, United States, 33014
        • Research Site
      • Miami Springs, Florida, United States, 33166
        • Research Site
      • North Miami Beach, Florida, United States, 33162
        • Research Site
      • Orlando, Florida, United States, 32806
        • Research Site
      • Ormond Beach, Florida, United States, 32174
        • Research Site
      • Port Orange, Florida, United States, 32127
        • Research Site
      • Saint Petersburg, Florida, United States, 33713
        • Research Site
      • Seminole, Florida, United States, 33777
        • Research Site
      • Winter Park, Florida, United States, 32789
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Research Site
      • Columbus, Georgia, United States, 31904
        • Research Site
    • Idaho
      • Boise, Idaho, United States, 83712
        • Research Site
    • Illinois
      • Burr Ridge, Illinois, United States, 60527
        • Research Site
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Chicago, Illinois, United States, 60640
        • Research Site
      • Gurnee, Illinois, United States, 60031
        • Research Site
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Research Site
      • Evansville, Indiana, United States, 47712
        • Research Site
      • South Bend, Indiana, United States, 46617
        • Research Site
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66204
        • Research Site
      • Wichita, Kansas, United States, 67214
        • Research Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Research Site
      • Lexington, Kentucky, United States, 40503
        • Research Site
      • Lexington, Kentucky, United States, 40509
        • Research Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Research Site
      • Metairie, Louisiana, United States, 70006
        • Research Site
      • New Orleans, Louisiana, United States, 70119
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
      • Boston, Massachusetts, United States, 02215
        • Research Site
      • Methuen, Massachusetts, United States, 01844
        • Research Site
      • Springfield, Massachusetts, United States, 01107
        • Research Site
      • Worcester, Massachusetts, United States, 01655
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Site
      • Farmington Hills, Michigan, United States, 48334
        • Research Site
      • Grand Rapids, Michigan, United States, 49525
        • Research Site
      • Novi, Michigan, United States, 48377
        • Research Site
      • Saint Clair Shores, Michigan, United States, 48081
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55446
        • Research Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Research Site
      • Kansas City, Missouri, United States, 64114
        • Research Site
      • Saint Louis, Missouri, United States, 63110
        • Research Site
      • Saint Louis, Missouri, United States, 63131
        • Research Site
    • Montana
      • Missoula, Montana, United States, 59808
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Research Site
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Research Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Research Site
    • New York
      • Buffalo, New York, United States, 14202
        • Research Site
      • Ridgewood, New York, United States, 11385
        • Research Site
      • Rochester, New York, United States, 14642
        • Research Site
      • Rochester, New York, United States, 14607
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28208
        • Research Site
      • Durham, North Carolina, United States, 27710
        • Research Site
      • Monroe, North Carolina, United States, 28112
        • Research Site
      • Morehead City, North Carolina, United States, 28557
        • Research Site
      • Wilmington, North Carolina, United States, 28403
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Research Site
      • Westlake, Ohio, United States, 44145
        • Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Research Site
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
      • Harrisburg, Pennsylvania, United States, 17110
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Research Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Research Site
      • North Charleston, South Carolina, United States, 29405
        • Research Site
      • Rock Hill, South Carolina, United States, 29732
        • Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Research Site
    • Texas
      • Austin, Texas, United States, 78745
        • Research Site
      • Dallas, Texas, United States, 75246
        • Research Site
      • El Paso, Texas, United States, 79925
        • Research Site
      • Houston, Texas, United States, 77070
        • Research Site
      • Houston, Texas, United States, 77054
        • Research Site
      • Houston, Texas, United States, 77089
        • Research Site
      • Houston, Texas, United States, 77081
        • Research Site
      • Houston, Texas, United States, 77065
        • Research Site
      • Kingwood, Texas, United States, 77339
        • Research Site
      • Mesquite, Texas, United States, 75150
        • Research Site
      • San Angelo, Texas, United States, 76904
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
      • Shenandoah, Texas, United States, 77384
        • Research Site
    • Utah
      • Layton, Utah, United States, 84041
        • Research Site
      • Salt Lake City, Utah, United States, 84115
        • Research Site
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Research Site
      • Norfolk, Virginia, United States, 23502
        • Research Site
      • Norfolk, Virginia, United States, 23507
        • Research Site
    • Washington
      • Olympia, Washington, United States, 98506
        • Research Site
      • Seattle, Washington, United States, 98109
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site
      • Hochiminh city, Vietnam, 700000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Parent study - Sentinel Safety Cohort Participants (Phase I):

Parent study - Sentinel Cohort Inclusion Criteria:

  • 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).
  • Age 18 to 55 years at the time of signing the informed consent.
  • Negative rapid antigen test at Visit 1.
  • Weight ≥ 45 kg and ≤ 110 kg at screening.

Parent study - Sentinel Cohort 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):

Parent study - Main Cohort Inclusion Criteria:

  • Participant must be 12 years of age or older at the time of signing the informed consent.
  • Negative rapid antigen test prior to dosing at Visit 1.
  • Weight ≥ 40 kg at screening.

  • 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:

      1. Have had a solid organ transplant within 2 years and / or
      2. Had a hematopoietic stem cell transplant within 2 years and / or
      3. Who have chronic graft-versus-host disease
      4. 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], 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 (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 AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
  • 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.
  • 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.

Parent study - Main Cohort 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. 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).

Sub-study - Inclusion Criteria (Phase II):

Sub-study - Sentinel Safety Cohort Inclusion Criteria:

  • Healthy, defined according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the Investigator.
  • Participants must be 18 to 55 years at the time of signing the informed consent.
  • Weight ≥ 45 kg and ≤ 110 kg at screening.

Sub-study - Full Sub-study Cohort Inclusion Criteria:

  • Immunocompromised or immunocompetent, including healthy participants, with all degrees of SARS-CoV-2 infection risk, will be enrolled following completion of Sentinel Safety Cohort enrolment.
  • Participants must be 18 years of age or older at the time of signing the informed consent.
  • Weight ≥ 40 kg at screening.

Sub-study - Sub-study Sentinel Safety Cohort and Full Sub-study Cohort Inclusion Criteria:

  • 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.
  • Negative rapid antigen test for SARS-CoV-2 prior to dosing at Visit 1.
  • Medically stable defined as disease not requiring significant change in maintenance therapy or hospitalization for worsening disease or any recent cardiovascular 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.
  • 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.

Sub-study - Exclusion Criteria (Phase II):

Sub-study - Sentinel Safety Cohort Exclusion Criteria:

  • 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.

Sub-study - Sentinel Safety Cohort and Full Sub-study Cohort Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - AZD5156
The Sentinel Safety Cohort of the Parent Study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: AZD5156 (Parent study Sentinel Safety Cohort)

600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL

3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1
Placebo Comparator: Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - Placebo
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: Placebo (Parent study Sentinel Safety Cohort)
single dose of Placebo (3 mL + 2 mL) IM
Experimental: Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - AZD5156
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: AZD5156 (Parent study Sentinel Safety Cohort)

600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL

3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1
Placebo Comparator: Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - Placebo
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: Placebo (Parent study Sentinel Safety Cohort)
single dose of Placebo (3 mL + 2 mL) IM
Experimental: Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal- AZD5156
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: AZD5156 (Parent study Sentinel Safety Cohort)

600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL

3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1
Placebo Comparator: Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal - Placebo
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: Placebo (Parent study Sentinel Safety Cohort)
single dose of Placebo (3 mL + 2 mL) IM
Experimental: Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - AZD5156
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: AZD5156 (Parent study Sentinel Safety Cohort)

600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL

3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1
Placebo Comparator: Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - Placebo
The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).
Biological: Placebo (Parent study Sentinel Safety Cohort)
single dose of Placebo (3 mL + 2 mL) IM
Experimental: Parent study Main Cohort - AZD3152
The Main Cohort of the Parent study will enroll approximately 3200 participants. Dosing in the Main Cohort will be staggered, so that it starts with adult participants aged 18 years and older, with no adolescent participants dosed in the Main Cohort until safety data from Visit 2a (Day 8) and Visit 2b (Day 15) have been reviewed by the DSMB for at least 80 adult Main Cohort participants (which will include at least 40 participants who have received AZD3152). Participants in the Main Cohort will be randomized 1:1 to receive AZD3152 300 mg or comparator administered IM in the anterolateral thigh on Day 1. Participants will receive a second dose of their original randomized study intervention (ie, active treatment or comparator) 6 months after Visit 1.
Biological: Placebo (Parent study Sentinel Safety Cohort)
single dose of Placebo (3 mL + 2 mL) IM
Biological: AZD3152 (Parent study Main Cohort)

300 mg AZD3152 at 150 mg/mL

1 IM injection (thigh) of 2 mL of AZD3152 on Visit 1 Day 1 and on Visit 5 Day 181
Active Comparator: Parent study Main Cohort - EVUSHELD™

Participants in the Main Cohort of the Parent study will be randomized 1:1 to receive AZD3152 300 mg or comparator administered IM in the anterolateral thigh on Day 1. Participants will receive a second dose of their original randomized study intervention (ie, active treatment or comparator) 6 months after Visit 1.

At the request of regulatory authorities the active comparator will be changed to placebo. As the comparator is given on two occasions, this means that a participant randomized to the comparator arm may receive (a) two doses of EVUSHELD, (b) a dose of EVUSHELD and a dose of placebo, or (c) two doses of placebo.
Biological: EVUSHELD™ (Parent study Main Cohort)

600 mg EVUSHELD™/AZD7442 consisting of 300 mg AZD1061 and 300 mg AZD8895, both at 100 mg/mL

2 IM injections (thigh) of 3 mL each IM on Visit 1 Day 1 and on Visit 5 Day 181

Other Names:
  • EVUSHELD™
Placebo Comparator: Parent study Main Cohort - Placebo

Participants in the Main Cohort of the Parent study will be randomized 1:1 to receive AZD3152 300 mg or comparator administered IM in the anterolateral thigh on Day 1. Participants will receive a second dose of their original randomized study intervention (ie, active treatment or comparator) 6 months after Visit 1.

At the request of regulatory authorities the active comparator will be changed to placebo. As the comparator is given on two occasions, this means that a participant randomized to the comparator arm may receive (a) two doses of EVUSHELD, (b) a dose of EVUSHELD and a dose of placebo, or (c) two doses of placebo.
Biological: Placebo (Parent study Main Cohort)
Single doses of 0.9% sodium chloride 2 mL IM for injection on Visit 1 Day 1 and Visit 5 Day 181
Experimental: Sub-study - AZD3152
This sub-study will enroll approximately 450 participants, ≥ 18 years of age with a minimum weight of 40 kg. An initial Sentinel Safety Cohort will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.
Biological: AZD3152 (Sub-study)
Single dose of 1200 mg IV at Visit 1 Day 1
Active Comparator: Sub-study - AZD7442 (EVUSHELD™)
This sub-study will enroll approximately 450 participants, ≥ 18 years of age with a minimum weight of 40 kg. An initial Sentinel Safety Cohort will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.
Biological: AZD7442 - EVUSHELD™ (Sub-study)
Single dose 300 mg IM administered on Visit 1 Day 1
Experimental: Sub-study - AZD7442 (EVUSHELD™) Immunocompromised participants offered AZD3152 1200mg IV
This sub-study will enroll approximately 450 participants, ≥ 18 years of age with a minimum weight of 40 kg. An initial Sentinel Safety Cohort will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.
Biological: AZD7442 (EVUSHELD™) (Sub-study) Immunocompromised participants offered AZD3152
Single dose of AZD7442 (EVUSHELD™) 300 mg IM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent study - Sentinel Safety Cohort: To evaluate the safety of AZD5156
Time Frame: AEs will be collected from IMP administration approximately 90 days following. AESIs will be collected from IMP administration through to Visit 11 (Day 361). SAEs and MAAEs will be collected up to Visit 11 (Day 361).
Occurence of AEs, SAEs, MAAEs, and AESIs will be collected throughout the study
AEs will be collected from IMP administration approximately 90 days following. AESIs will be collected from IMP administration through to Visit 11 (Day 361). SAEs and MAAEs will be collected up to Visit 11 (Day 361).
Parent study - Main Cohort: To evaluate the safety of AZD3152 and EVUSHELD and/or placebo
Time Frame: Occurrence of AEs collected through approximately 90 days after each IMP administration through to Visit 10 (Day 451). SAEs and MAAEs will be collected up to Visit 10 (Day 451).
Occurrence of AEs, SAEs, MAAEs, and AESIs will be collected throughout the study
Occurrence of AEs collected through approximately 90 days after each IMP administration through to Visit 10 (Day 451). SAEs and MAAEs will be collected up to Visit 10 (Day 451).
Sub-study: To evaluate the safety of AZD3152 and EVUSHELD
Time Frame: SAEs, MAAEs, and AESIs collected throughout the study for the final analysis.
Occurrence of AEs collected through 29 days after IMP administration for the primary analysis.
SAEs, MAAEs, and AESIs collected throughout the study for the final analysis.
Sub-study: To compare the SARS-CoV-2 nAb responses to a current VOC following AZD3152 administration vs SARS-CoV-2 nAb responses to prior variants following EVUSHELD administration
Time Frame: Predicted GMT ratio of SARS-CoV-2 nAbs between the treatment arms at Visit 3 (Day 29) for the variant that each IMP is intended to neutralize.
SARS-CoV-2 nAb responses to a current VOC following AZD3152 administration vs SARS-CoV-2 nAb responses to prior variants following EVUSHELD administration.
Predicted GMT ratio of SARS-CoV-2 nAbs between the treatment arms at Visit 3 (Day 29) for the variant that each IMP is intended to neutralize.
Parent study-Main cohort: 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
Time Frame: Confirmed symptomatic COVID-19 case is evaluated from first dose up to 181 days after last dose. For participants that receive two doses, the evaluation period would be approximately 361 days.
Endpoint: Confirmed symptomatic COVID-19 case, classified as a binary outcome incorporating the time from the first dose of IMP until a participant develops their first symptoms for COVID-19 or are censored. Summary measure: Prophylactic efficacy, calculated as 1 - Hazard Ratio (HR) (AZD3152 versus EVUSHELD and/or placebo) using a hazard regression model.
Confirmed symptomatic COVID-19 case is evaluated from first dose up to 181 days after last dose. For participants that receive two doses, the evaluation period would be approximately 361 days.
Parent study - Main cohort: 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)
Time Frame: Confirmed symptomatic COVID-19 case is evaluated from first dose up to 181 days after last dose. For participants that receive two doses, the evaluation period would be approximately 361 days.
Endpoint: Confirmed symptomatic COVID-19 case attributable to matched variants, classified as a binary outcome incorporating the time from the first dose of IMP until a participant develops their first symptoms for COVID-19 or are censored. Summary measure: Prophylactic efficacy, calculated as 1 - Hazard Ratio (HR) (AZD3152 versus EVUSHELD and/or placebo) using a hazard regression model.
Confirmed symptomatic COVID-19 case is evaluated from first dose up to 181 days after last dose. For participants that receive two doses, the evaluation period would be approximately 361 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent study - Sentinel Safety Cohort: To characterize the Pharmacokinetics of AZD5156 (AZD1061 and AZD3152) in serum.
Time Frame: Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361).
AZD5156 (AZD1061 and AZD3152) serum concentrations at each visit.
Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361).
Parent study - Sentinel Safety Cohort: To characterize the Pharmacokinetics parameter of maximum concentration (Cmax) of AZD5156 (AZD1061 and AZD3152) in serum
Time Frame: Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361)
To describe maximum concentration (Cmax) for AZD5156 (AZD1061 and AZD3152).
Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361)
Parent study - Sentinel Safety Cohort: To characterize the Pharmacokinetics parameter of time to maximum serum concentration (tmax) of AZD5156 (AZD1061 and AZD3152) in serum
Time Frame: Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361).
To describe time to maximum serum concentration (tmax) for AZD5156 (AZD1061 and AZD3152).
Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361).
Parent study - Sentinel Safety Cohort: To characterize the Pharmacokinetics parameter of terminal half-life (t½) of AZD5156 (AZD1061 and AZD3152) in serum
Time Frame: Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361).
To describe terminal half-life (t½) for AZD5156 (AZD1061 and AZD3152).
Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361).
Parent study - Sentinel Safety Cohort: To characterize the Pharmacokinetics parameter of area under the concentration-time curve at the last measured time point (AUClast) of AZD5156 (AZD1061 and AZD3152) in serum
Time Frame: Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361).
To describe area under the concentration-time curve at the last measured time point (AUClast) for AZD5156 (AZD1061 and AZD3152).
Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361).
Parent study - Sentinel Safety Cohort: To characterize the Pharmacokinetics parameter of area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of AZD5156 (AZD1061 and AZD3152) in serum
Time Frame: Samples will be collected from visit 1 (Day 1) up to visit 11 (Day 361).
To describe area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) for AZD5156 (AZD1061 and AZD3152).
Samples will be collected from visit 1 (Day 1) up to visit 11 (Day 361).
Parent study - Sentinel Safety Cohort: To evaluate the ADA responses to AZD5156, AZD3152, and AZD1061 in serum
Time Frame: Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361)
Incidence of ADA to AZD5156, AZD3152, and AZD1061, ADA titers
Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361)
Parent study - Main Cohort: To compare the nAb responses to the SARS-CoV-2 variants Alpha, Omicron BA.2, Omicron BA.4/5 and/or Omicron XBB.1.5 in serum following AZD3152 and EVUSHELD and/or placebo administration
Time Frame: Visit 3 (Day 29)

GMT and GMFR ratio of SARS-CoV-2 nAbs between the treatment arms at Visit 3 (Day 29).

Descriptive statistics for GMTs and GMFRs will be provided.
Visit 3 (Day 29)
Parent study - Main Cohort: To characterize the Pharmacokinetics (PK)of the AZD3152 and AZD7442 (AZD1061 and AZD8865) in serum concentrations at each visit.
Time Frame: Samples will be collected from Visit 1 (Day 1) up to Visit 9 (Day 361)
AZD3152 and AZD7442 (AZD1061 and AZD8895) serum concentrations at each visit.
Samples will be collected from Visit 1 (Day 1) up to Visit 9 (Day 361)
Parent study - Main Cohort: To evaluate the Anti-drug Antibodies (ADA) responses to AZD3152 and AZD7442 in serum
Time Frame: Samples will be collected from Visit 1 (Day 1) up to Visit 9 (Day 361)
Incidence of Anti-drug Antibodies (ADA) to AZD3152, AZD7442, AZD1061, and AZD8895, ADA titers
Samples will be collected from Visit 1 (Day 1) up to Visit 9 (Day 361)
Sub-study: To characterize the Pharmacokinetics of AZD3152 and AZD7442 (EVUSHELD) in serum
Time Frame: Samples will be collected from Visit 1 (Day 1) up to Visit 5 (Day 181).
AZD3152, AZD7442 (EVUSHELD), cilgavimab, and tixagevimab concentrations in serum, over time
Samples will be collected from Visit 1 (Day 1) up to Visit 5 (Day 181).
Sub-study:To evaluate the ADA response to AZD3152 and AZD7442 (EVUSHELD) in serum
Time Frame: Samples will be collected from Visit 1 (Day 1) up to Visit 5 (Day 181).
Incidence of ADA to AZD3152, AZD7442 (EVUSHELD), cilgavimab, and tixagevimab; ADA titers
Samples will be collected from Visit 1 (Day 1) up to Visit 5 (Day 181).
Parent study - Main Cohort: To describe the incidence of symptomatic COVID-19, severe COVID-19, COVID-19 related hospitalization, and COVID-19 related death in participants receiving study intervention
Time Frame: COVID-19 incidence variables to be evaluated through Visit 9 (Day 361)

Incidence of a post-treatment:

  • Symptomatic COVID-19 case (negative RT-PCR at baseline to positive at any time up to 6 and 12 months) caused by any SARS-CoV-2 variant
  • Symptomatic COVID-19 case (negative RT-PCR at baseline to positive at any time up to 6 and 12 months) caused by any SARS-CoV-2 matched variants
  • Severe COVID-19 caused by any SARS-CoV-2 variant
  • Severe COVID-19 caused by any SARS-CoV-2 matched variants
  • Composite of COVID-19 related hospitalization and/or COVID-19 related death (WHO COVID-19 Clinical Progression Scale score ≥ 4)
  • COVID-19 related hospitalization (separately)
  • COVID-19 related death (separately)
COVID-19 incidence variables to be evaluated through Visit 9 (Day 361)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2022

Primary Completion (Actual)

September 7, 2023

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

December 12, 2022

First Posted (Actual)

December 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D7000C00001
  • 2022-002378-95 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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