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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,882
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
single dose of Placebo (3 mL + 2 mL) IM
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
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
Single doses of 0.9% sodium chloride 2 mL IM for injection on Visit 1 Day 1 and Visit 5 Day 181
Single dose of 1200 mg IV at Visit 1 Day 1
Single dose 300 mg IM administered on Visit 1 Day 1
Single dose of AZD7442 (EVUSHELD™) 300 mg IM
Research Site
Birmingham, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Glendale, Arizona, United States
Research Site
Mesa, Arizona, United States
Research Site
(Main Cohort) Occurrence of AEs Collected Through Approximately 90 Days After Each IMP Administration; SAEs, MAAEs, and AESIs Collected Through Day 451
Primary: (Main Cohort) Occurrence of AEs collected through approximately 90 days after each IMP administration; SAEs, MAAEs, and AESIs collected through Day 451
Time frame: AEs: through 90 days post each IMP administration; SAEs, MAAEs, and AESIs: through Day 451
(Sub-study) Occurrence of AEs Collected Through 29 Days After IMP Administration. SAEs, MAAEs, and AESIs Collected Through Day 451.
(Sub-study) Occurrence of AEs collected through 29 days after IMP administration. SAEs, MAAEs, and AESIs collected through Day 451 (ie, end of study).
Time frame: through 29 days post IMP administration (AEs); through Day 451 (SAEs, MAAEs, and AESIs)
(Sub-study) Predicted SARS-CoV-2 nAb Titers Derived From Serum PK and in Vitro IC50 for SARS-CoV-2 Variants BA.2.86 Following AZD3152 Administration and Alpha Variant Following EVUSHELD Administration.
AZD3152 Day 29 predicted nAb titer for BA.2.86 variant = AZD3152 serum PK conc. (ng/mL)/(3.8 ng/mL), where 3.8 ng/mL is AZD3152 BA.2.86 IC50. AZD7442 Day 29 predicted nAb titer for Alpha variant = AZD7442 serum PK conc. (ng/mL)/(2.1 ng/mL), where 2.1 ng/mL is AZD7442 Alpha IC50. This table only shows AZD3152 and AZD7442 concentration at Day 29.
Time frame: at Day 29
(Sub-study) Predicted SARS-CoV-2 nAb Titers Derived From Serum PK and in Vitro IC50 for SARS-CoV-2 Variants BA.2.86 Following AZD3152 Administration and Alpha Variant Following EVUSHELD Administration.
AZD3152 Day 29 predicted nAb titer for BA.2.86 variant = AZD3152 serum PK conc. (ng/mL)/(3.8 ng/mL), where 3.8 ng/mL is AZD3152 BA.2.86 IC50. AZD7442 Day 29 predicted nAb titer for Alpha variant = AZD7442 serum PK conc. (ng/mL)/(2.1 ng/mL), where 2.1 ng/mL is AZD7442 Alpha IC50. This table shows the predicted nAb titer at Day 29 (please see the previous table for AZD3152 and AZD7442 concentration at Day 29).
Time frame: at Day 29
(Main Cohort) Confirmed Symptomatic COVID-19 Case
(Main Cohort) Confirmed symptomatic COVID-19 case at Primary Analysis.
Time frame: at Primary Analysis: average follow-up time of 170 days
(Main Cohort) Confirmed Symptomatic COVID-19 Case Attributable to Matched Variants
(Main Cohort) Confirmed symptomatic COVID-19 case attributable to matched variants at Primary Analysis.
Time frame: at Primary Analysis: average follow-up time of 170 days
(Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs Collected Through Day 461
Primary: (Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs collected through Day 461
Time frame: through Day 461
(Sub-study) AZD3152 and EVUSHELD (ie, AZD7442) Concentrations in Serum, Over Time
Secondary: (Sub-study) AZD3152 and EVUSHELD (ie, AZD7442) concentrations in serum, over time.
Time frame: Day 29, Day 91, Day 181
(Sub-study) Incidence of ADA to AZD3152 and EVUSHELD
AZD3152 recipients were tested for ADA to AZD3152; EVUSHELD recipients were tested for ADA to EVUSHELD.
Time frame: through Day 181
(Sub-study) Cilgavimab and Tixagevimab Concentrations in Serum, Over Time
AZD7442 (ie EVUSHELD) is composed of cilgavimab and tixagevimab. This summary is only applicable to AZD7442 group.
Time frame: Day 29, Day 91, Day 181
(Sub-study) ADA Titers
ADA titers were only available for ADA positive samples.
Time frame: Day 1, Day 29, Day 91, Day 181
(Main Cohort) Symptomatic COVID-19 Case (Negative RT-PCR at Baseline to Positive at Any Time up 12 Months With All Observed Events at Final Readout) Caused by Any SARS-CoV-2 Matched Variant
(Main Cohort) Symptomatic COVID-19 case (negative RT-PCR at baseline to positive at any time up 12 months with all observed events at final readout) caused by any SARS-CoV-2 matched variant. First secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
Time frame: through Day 361
(Main Cohort) Symptomatic COVID-19 Case (Negative RT-PCR at Baseline to Positive at Any Time up to 12 Months With All Observed Events at Final Readout) Caused by Any SARS-CoV-2 Variants
Secondary: (Main Cohort) Symptomatic COVID-19 case (negative RT-PCR at baseline to positive at any time up to 12 months with all observed events at final readout) caused by any SARS-CoV-2 variants. Second secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
Time frame: through Day 361
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mesa, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Colton, California, United States
Research Site
La Mesa, California, United States
...and 205 more locations
(Main Cohort) Severe COVID-19 Caused by Any SARS-CoV-2 Variant Any Time up to 12 Months
third secondary endpoint to be tested in hierarchical testing after dual-primary endpoint efficacy was demonstrated in hierarchical testing
Time frame: through Day 361
(Main Cohort) Severe COVID-19 Caused by Any SARS-CoV-2 Matched Variants at Any Time up to 12 Months
Secondary: (Main Cohort) Severe COVID-19 caused by any SARS-CoV-2 matched variants at any time up to 12 months through Day 361.
Time frame: through Day 361
(Main Cohort) Composite of COVID-19-related Hospitalization and/or COVID-19-related Death (WHO COVID-19 Clinical Progression Scale Score ≥ 4) Any Time up to 12 Months
Secondary: (Main Cohort) Composite of COVID-19-related hospitalization and/or COVID-19-related death (WHO COVID-19 Clinical Progression Scale score ≥ 4) any time up to 12 months.
Time frame: through Day 361
(Main Cohort) COVID-19-related Hospitalization Any Time up to 12 Months
Secondary: (Main Cohort) COVID-19-related hospitalization any time up to 12 months.
Time frame: through Day 361
(Main Cohort) COVID-19 Related Death
(Main Cohort) COVID-19 related death - through Day 361
Time frame: through Day 361
(Main Cohort) GMT of SARS-CoV-2 nAbs at Baseline and Day 29
Secondary: (Main Cohort) GMT of SARS-CoV-2 nAbs at baseline and Day 29
Time frame: at Day 29
(Main Cohort) GMFR of SARS-CoV-2 nAbs at Day 29
Secondary: (Main Cohort) GMFR of SARS-CoV-2 nAbs at Day 29
Time frame: at Day 29
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) Concentrations Over Time
(Main Cohort) AZD3152 and AZD7442 (EVUSHELD) concentrations over time - through Day 361
Time frame: through Day 361
(Main Cohort) Incidence of ADA to AZD3152 and AZD7442 (EVUSHELD)
AZD3152 recipients were tested for ADA to AZD3152; AZD7442 recipients were tested for ADA to AZD7442.
Time frame: through Day 361
(Sentinel Cohort) AZD5156, AZD1061, and AZD3152 Concentrations Over Time
AZD5156 is a combination of AZD3152 and AZD1061. This summary is only eligible for AZD5156 group.
Time frame: Day 29, Day 181, Day 361
(Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061
(Sentinel Cohort) Incidence of ADA to AZD5156, AZD3152, and AZD1061 - through Day 361
Time frame: through Day 361
(Main Cohort) ADA Titers
ADA titers were only available for ADA positive samples.
Time frame: through Day 361
(Main Cohort) AZD1061 and AZD8895 Concentrations Over Time
AZD7442 (ie EVUSHELD) is composed of AZD1061 (ie, cilgavimab) and AZD8895 (ie, tixagevimab). This summary is only applicable to AZD7442 group.
Time frame: through Day 361