Novel Antibody Prophylaxis for COVID-19
(SUPERNOVA Trial)
Recruiting in Palo Alto (17 mi)
+233 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: AstraZeneca
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug, AZD3152, and a combination drug to see if they can prevent COVID-19. It focuses on people with weak immune systems who might not respond well to vaccines, as well as healthy adults. The drug works by blocking the virus from entering cells.
Research Team
Eligibility Criteria
This trial is for people aged 18-55 with certain immune deficiencies or conditions like DiGeorge syndrome, Wiskott-Aldrich syndrome, or those who have had specific treatments like CAR T cell therapy. It's also open to healthy individuals without concomitant diseases and those with stable chronic graft-versus-host disease or active cancer on immunosuppressants. Participants must not be pregnant, using effective contraception if of childbearing potential.Inclusion Criteria
My weight is between 45 and 110 kg.
I weigh at least 40 kg.
I am 12 years old or older.
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Exclusion Criteria
I have taken a COVID-19 antiviral for prevention in the last 3 months.
I have received EVUSHELD within the last year.
Known hypersensitivity to any component of the study intervention
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Treatment Details
Interventions
- AZD3152 (Monoclonal Antibodies)
- AZD5156 (Monoclonal Antibodies)
- AZD7442 (Monoclonal Antibodies)
Trial OverviewThe study tests AZD3152 alone and in combination (AZD5156) against EVUSHELD for COVID-19 pre-exposure prophylaxis. The main study evaluates safety and efficacy while the sub-study focuses on comparing AZD3152 with EVUSHELD specifically in immunocompromised patients.
Participant Groups
14Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Sub-study - AZD7442 (EVUSHELD™) Immunocompromised participants offered AZD3152 1200mg IVExperimental Treatment1 Intervention
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.
Group II: Sub-study - AZD3152Experimental Treatment1 Intervention
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.
Group III: Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - AZD5156Experimental Treatment1 Intervention
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).
Group IV: Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal- AZD5156Experimental Treatment1 Intervention
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).
Group V: Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - AZD5156Experimental Treatment1 Intervention
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).
Group VI: Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - AZD5156Experimental Treatment1 Intervention
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).
Group VII: Parent study Main Cohort - AZD3152Experimental Treatment2 Interventions
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.
Group VIII: Parent study Main Cohort - EVUSHELD™Active Control1 Intervention
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.
Group IX: Sub-study - AZD7442 (EVUSHELD™)Active Control1 Intervention
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.
Group X: Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal - PlaceboPlacebo Group1 Intervention
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).
Group XI: Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - PlaceboPlacebo Group1 Intervention
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).
Group XII: Parent study Main Cohort - PlaceboPlacebo Group1 Intervention
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.
Group XIII: Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - PlaceboPlacebo Group1 Intervention
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).
Group XIV: Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - PlaceboPlacebo Group1 Intervention
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Trials
4,491
Recruited
290,540,000+
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology