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

• ClinicalTrials.gov Identifier: NCT05648110
• Recruitment Status: Recruiting
• First Posted: December 13, 2022
• Last Update Posted: March 17, 2023
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Study Description

Brief Summary:

The aim of this phase I/III study will be to evaluate the safety and neutralizing activity of AZD3152 compared with AZD7442 for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061.

Condition or disease	Intervention/treatment	Phase
COVID-19, SARS-CoV-2	Biological: AZD5156 (Sentinel Safety Cohort); Biological: Placebo (Sentinel Safety Cohort); Biological: AZD7442 (EVUSHELD™) (Main Cohort); Biological: AZD3152 (Main Cohort)	Phase 3

Detailed Description:

The Phase I Sentinel Safety Cohort will assess the safety of AZD5156 (a combination of 2 mAbs, AZD1061 [cilgavimab, a component of the established therapy AZD7442] and AZD3152) in healthy adults.The Phase III Main Cohort will assess the safety and neutralizing activity of AZD3152 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 high risk of developing severe COVID 19 in approximately 20 countries.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 3256 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: D7000C00001 is a Phase I/III study that will be conducted in approx. 3256 participants to evaluate the safety and neutralizing activity of AZD3152 compared with AZD7442 for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152& AZD1061. The study will consist of 2 cohorts: a Sentinel and Main Cohort. The Sentinel Cohort will enroll 56 healthy adults, 18-55 years old, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Dosing in the Sentinel Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, 2b). An ESDR will be conducted after Visit 4 (Day 8) and Visit 5 (Day 15) of each subcohort. Participants in the Main Cohort will be randomized 1:1 to receive AZD3152 (+placebo to preserve the blind) or AZD7442 administered IM in the thigh on Day 1. Participants will receive a 2nd dose of their original randomized study intervention 6 months after Visit 1.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase I/III Randomized, Double Blind Study to Evaluate the Safety and Neutralizing Activity of AZD5156/AZD3152 for Pre Exposure Prophylaxis of COVID 19 in Participants With Conditions Causing Immune Impairment
• Actual Study Start Date: December 16, 2022
• Estimated Primary Completion Date: November 30, 2023
• Estimated Study Completion Date: November 22, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sentinel Safety Cohort - Subcohort 1a Gluteal - AZD5156; The Sentinel Safety Cohort 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 (Sentinel Safety Cohort); 600 mg single dose of AZD5156 IM (300 mg of AZD1061 and 300 mg of AZD3152) on Visit 1 Day 1
Placebo Comparator: Sentinel Safety Cohort - Subcohort 1a Gluteal - Placebo; The Sentinel Safety Cohort 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 (Sentinel Safety Cohort); single dose of Placebo IM
Experimental: Sentinel Safety Cohort - Subcohort 1b Thigh - AZD5156; The Sentinel Safety Cohort 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 (Sentinel Safety Cohort); 600 mg single dose of AZD5156 IM (300 mg of AZD1061 and 300 mg of AZD3152) on Visit 1 Day 1
Placebo Comparator: Sentinel Safety Cohort - Subcohort 1b Thigh - Placebo; The Sentinel Safety Cohort 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 (Sentinel Safety Cohort); single dose of Placebo IM
Experimental: Sentinel Safety Cohort - Subcohort 2a Gluteal- AZD5156; The Sentinel Safety Cohort 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 (Sentinel Safety Cohort); 600 mg single dose of AZD5156 IM (300 mg of AZD1061 and 300 mg of AZD3152) on Visit 1 Day 1
Placebo Comparator: Sentinel Safety Cohort - Subcohort 2a Gluteal - Placebo; The Sentinel Safety Cohort 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 (Sentinel Safety Cohort); single dose of Placebo IM
Experimental: Sentinel Safety Cohort - Subcohort 2b Thigh - AZD5156; The Sentinel Safety Cohort 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 (Sentinel Safety Cohort); 600 mg single dose of AZD5156 IM (300 mg of AZD1061 and 300 mg of AZD3152) on Visit 1 Day 1
Placebo Comparator: Sentinel Safety Cohort - Subcohort 2b Thigh - Placebo; The Sentinel Safety Cohort 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 (Sentinel Safety Cohort); single dose of Placebo IM
Experimental: Main Cohort - AZD3152; Main Cohort will enroll approximately 3200 participants, 12 years of age or older with a minimum weight of 40 kg with conditions causing immune impairment, who are less likely to mount an adequate protective immune response after vaccination and thus are at high risk of developing severe COVID-19. Participants in the Main Cohort will be randomized 1:1 to receive AZD3152 (plus an administration of placebo to preserve the blind) or AZD7442 administered IM in the thigh on Day 1 and will receive a second dose of their original randomized study intervention 6 months after Visit 1.	Biological: Placebo (Sentinel Safety Cohort); single dose of Placebo IM; Biological: AZD3152 (Main Cohort); 300 mg single doses of AZD3152 (plus single dose administration of placebo to preserve the blind) on Visit 1 Day 1 and on Visit 5 Day 181
Active Comparator: Main Cohort - AZD7442 (EVUSHELD™); Main Cohort will enroll approximately 3200 participants, 12 years of age or older with a minimum weight of 40 kg with conditions causing immune impairment, who are less likely to mount an adequate protective immune response after vaccination and thus are at high risk of developing severe COVID-19. Participants in the Main Cohort will be randomized 1:1 to receive AZD3152 (plus an administration of placebo to preserve the blind) or AZD7442 administered IM in the thigh on Day 1 and will receive a second dose of their original randomized study intervention 6 months after Visit 1.	Biological: AZD7442 (EVUSHELD™) (Main Cohort); 600 mg single doses of AZD7442 IM on Visit 1 Day 1 and on Visit 5 Day 181; Other Name: EVUSHELD™

Outcome Measures

Primary Outcome Measures :

1. Sentinel Safety Cohort: To evaluate the safety of AZD5156 [ Time Frame: AEs will be collected from IMP administration through 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
2. Main Cohort: To compare the nAb responses in serum following AZD3152 and AZD7442 administration to the SARS-CoV-2 Alpha variant in serum [ Time Frame: GMT ratio of SARS-CoV-2 nAbs between the treatment arms at Visit 3 (Day 29). Descriptive statistics of SARS-CoV-2 nAb titers will be made by visit. ]
   Participants who experience a protocol deviation that can interfere with an antibody response or violate adherence to the assigned dose, become infected, receive COVID 19 treatment or vaccination that can alter nAb levels will have data collected after the intercurrent event set to missing for analysis of the primary endpoint.
3. Main Cohort: To evaluate the safety of AZD3152 and AZD7442 [ Time Frame: AEs will be collected from IMP administration through 90 days following. AESIs will be collected from 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

Secondary Outcome Measures :

1. 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.
2. 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).
3. 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).
4. 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).
5. 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).
6. 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).
7. Sentinel Safety Cohort: To evaluate the ADA responses to AZD5156 in serum [ Time Frame: Samples will be collected from Visit 1 (Day 1) up to Visit 11 (Day 361) ]
   Incidence of ADA
8. Main Cohort:To compare the nAb responses to the SARS CoV 2 Omicron variants BA.2 and/or BA.4/5 and the emerging variants of concern circulating during the course of the study in serum following AZD3152 and AZD7442 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.

9. Main Cohort: To describe the incidence of 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 post treatment:

   • COVID-19 case (negative RT-PCR at baseline to positive at any time up to 6 and 12 months)
   • Severe COVID-19
   • 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)
10. Main Cohort:To compare the efficacy of AZD3152 to AZD7442 in the prevention of symptomatic COVID-19 [ Time Frame: Covid-19 Efficacy variables to be evaluated through Visit 9 (Day 361) ]

    Time from the first dose of IMP to the first occurrence of a symptomatic COVID-19 case. COVID-19 case defined as:

    • Negative RT-PCR at baseline to positive at any time up to Visit 9 (12 months) AND
    • Satisfying modified WHO definition of symptomatic COVID-19 Prophylactic efficacy, calculated as 1-HR (AZD3152 versus AZD7442)
11. Main Cohort: To characterize the Pharmacokinetics 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.
12. 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)

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

For Sentinel Safety Cohort Participants (Phase I)

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.

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.

For Main Cohort Participants (Phase III)

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 at Visit 1 and Visit 5.
• Weight ≥ 40 kg at Visit 1 and Visit 5

• Participants must satisfy at least 1 of the following risk factors at enrollment:

  • Have solid tumor cancer and be on active treatment except for adequately treated:

    1. Non-melanoma skin cancer or lentigo maligna
    2. Uterine cervical carcinoma in situ
    3. Local prostate carcinoma
  • Have hematologic malignancy
  • 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)
  • 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)
  • 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 or secondary immunodeficiency (eg, for primary: DiGeorge syndrome, Wiskott-Aldrich syndrome, severe combined immunodeficiency, common variable immunodeficiency, agammaglobulinemiaeg, for secondary: hemodialysis)
• 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.
• 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.

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.
• 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 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).

Contacts and Locations

Contacts

Contact: AstraZeneca Clinical Study Information Center; 1-877-240-9479; information.center@astrazeneca.com

Locations

United States, Missouri

Research Site; Recruiting

Kansas City, Missouri, United States, 64114

United States, Tennessee

Research Site; Recruiting

Knoxville, Tennessee, United States, 37920

Korea, Republic of

Research Site; Not yet recruiting

Gyeonggi-do, Korea, Republic of, 13620

Research Site; Not yet recruiting

Seoul, Korea, Republic of, 03080

Research Site; Not yet recruiting

Seoul, Korea, Republic of, 5505

Poland

Research Site; Not yet recruiting

Krakow, Poland, 30-510

Research Site; Not yet recruiting

Lublin, Poland, 20-362

South Africa

Research Site; Withdrawn

Newton, South Africa, 2113

Spain

Research Site; Not yet recruiting

Majadahonda, Spain, 28222

Research Site; Not yet recruiting

Marbella (Málaga), Spain, 29603

Research Site; Not yet recruiting

Mérida, Spain, 06800

Research Site; Not yet recruiting

Pozuelo de Alarcón, Spain, 28223

Taiwan

Research Site; Withdrawn

Taipei, Taiwan, TAIWAN

United Kingdom

Research Site; Recruiting

London, United Kingdom, W1T 7HA

Research Site; Recruiting

Manchester, United Kingdom, M8 5RB

Research Site; Recruiting

Oxford, United Kingdom, OX3 7LA

Sponsors and Collaborators

AstraZeneca

More Information

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• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT05648110
• Other Study ID Numbers: D7000C00001
• First Posted: December 13, 2022
• Last Update Posted: March 17, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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.

• Supporting Materials: Study Protocol
• 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.
• 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.
• URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AstraZeneca:

Pre-exposure Prophylaxis of COVID-19

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases