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Novel Antibody Prophylaxis for COVID-19 (SUPERNOVA Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up saes, maaes, and aesis collected throughout the study for the final analysis.
Awards & highlights
SUPERNOVA Trial Summary
This trial will test two drugs and a drug combo to prevent COVID-19 infection. It'll measure safety, how well they work, and how the body processes them.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the medication components, infusion-related reactions from monoclonal antibodies such as AZD7442 (EVUSHELD), and general side effects that can occur with antibody treatments.
SUPERNOVA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Parent study - Main Cohort: To evaluate the safety of AZD3152 and EVUSHELD and/or placebo
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)
Parent study - Sentinel Safety Cohort: To evaluate the safety of AZD5156
+3 moreSecondary outcome measures
Parent study - Main Cohort: To characterize the Pharmacokinetics (PK)of the AZD3152 and AZD7442 (AZD1061 and AZD8865) in serum concentrations at each visit.
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
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
+10 moreSUPERNOVA Trial Design
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 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 XI: 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).
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 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 XIV: 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).
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,589,904 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken a COVID-19 antiviral for prevention in the last 3 months.I have received EVUSHELD within the last year.I have not had COVID-19 in the last 3 months.I have a history of significant bleeding or bruising from shots or blood draws.I have received COVID-19 plasma treatment in the last 6 months.I have had no cancers in the past 5 years, except for skin cancer or treated cervical cancer.I have a severe immune system disorder like DiGeorge or Wiskott-Aldrich syndrome.I did not have a fever or infection the day before or on the day I was supposed to start treatment.I have received a monoclonal antibody treatment for COVID-19.I do not have an active hepatitis B or C infection.I am HIV positive.I have received a COVID-19 vaccine in the last 3 months.My weight is between 45 and 110 kg.I weigh at least 40 kg.I am 12 years old or older.I am between 18 and 55 years old.I have received or will receive immunoglobulin or blood products within 6 months.I have not received immunoglobulin injections in the last 6 months and do not plan to receive any in the next 6 months.I have cancer and am either on immunosuppressive treatment or have blood cancer.I have taken a COVID-19 antiviral as a preventive measure within the last 2 weeks.I am not pregnant, breastfeeding, and if capable of becoming pregnant, I use effective birth control or practice abstinence.I had an organ or stem cell transplant over 2 years ago.I have not received immunoglobulin or blood products in the last 6 months.I have cancer, but it's not non-melanoma skin cancer, cervical carcinoma in situ, or local prostate cancer that's been treated.I have a blood cancer.I have not had B-cell depleting therapy in the last year.You tested negative for COVID-19 using a rapid test at your first visit.I have a moderate or severe immune system problem.I have received CAR T cell therapy.My HIV infection is advanced or untreated.I received a treatment that targets B-cells within the last year.You have a long-term complication called graft-versus-host disease.I have cancer and am currently on treatment to suppress my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - Placebo
- Group 2: Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - Placebo
- Group 3: Parent study Main Cohort - AZD3152
- Group 4: Parent study Main Cohort - Placebo
- Group 5: Parent study Main Cohort - EVUSHELD™
- Group 6: Sub-study - AZD7442 (EVUSHELD™) Immunocompromised participants offered AZD3152 1200mg IV
- Group 7: Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal - Placebo
- Group 8: Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - AZD5156
- Group 9: Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - AZD5156
- Group 10: Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - Placebo
- Group 11: Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal- AZD5156
- Group 12: Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - AZD5156
- Group 13: Sub-study - AZD3152
- Group 14: Sub-study - AZD7442 (EVUSHELD™)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks have been associated with Main Cohort - AZD5156?
"There is sufficient clinical evidence backing the safety of AZD5156, so it is awarded a score of 3."
Answered by AI
Are there any available slots for individuals to join this research project?
"Indeed. According to the clinicaltrials.gov listing, this research is presently recruiting patients who meet its specific criteria. The trial was initially posted on December 16th 2022 and updated most recently on February 6th 2023; 3256 participants are required across one site."
Answered by AI
How many people have signed up to participate in this clinical research?
"Affirmative. Clinicaltrials.gov affirms that this ongoing medical trial, initially posted on December 16th 2022, is actively seeking participants. 3256 patients need to be recruited from 1 research center."
Answered by AI
Are there specific objectives that this trial seeks to accomplish?
"According to the trial sponsor, AstraZeneca, the primary outcome being measured over a defined time period is serum nAb responses following AZD3152 and AZD7442 administration for SARS-CoV-2 Alpha variant. The secondary outcomes comprise of AE proportions until 29 days post second dose of study intervention given at 6 months; SAEs and AESIs through last visit (Visit 9), concentration levels of serum AZD5156, AZD1061, and ADA response rates to an open label dose ofAZd 5156 IM among participants who received either AZd 5156 or 7442 during Part A Main Coh"
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Massachusetts
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Trying to make changes due. To help people and get paid. Because my age, want to get protection as mucj as possible.
PatientReceived no prior treatments
I love making contribution to society like I did with the vaccine for the coronavirus I was one of the pioneers, a volunteer who helped made it happen for the world.
PatientReceived 1 prior treatment
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