Parent Study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA) Sub-st… (NCT05648110) | Clinical Trial Compass
CompletedPhase 2/3
Parent Study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA Sub-study)
United States, Australia, Belgium3,882 participantsStarted 2022-12-16
Plain-language summary
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.
Who can participate
Age range
12 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Have had a solid organ transplant within 2 years and / or
. Had a hematopoietic stem cell transplant within 2 years and / or
. Who have chronic graft-versus-host disease
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a monoclonal antibody called AZD3152 for pre-exposure prevention of COVID-19 — since the study is now completed, has any safety or effectiveness data been published that you could walk me through to help us understand how it performed?
2The trial tracked serious adverse events and other safety signals for up to 451 days after dosing — based on what's been reported so far, are there any safety concerns from that long follow-up period that would be relevant to my situation?
3The sub-study specifically looked at how well AZD3152 neutralized newer variants like BA.2.86 — given that COVID variants keep evolving, does the antibody coverage data from this trial still seem relevant to the strains circulating now?
4Since this was a Phase 2/3 trial, the full safety and benefit picture may still be emerging — would you recommend waiting to see the final published results before considering a similar antibody-based prevention approach, or are there already approved options we should discuss first?
5For someone in my situation — particularly if I'm immunocompromised or can't mount a strong vaccine response — is a pre-exposure monoclonal antibody strategy something worth actively exploring with you, based on what this trial and others like it have found?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
(Main Cohort) Occurrence of AEs Collected Through Approximately 90 Days After Each IMP Administration; SAEs, MAAEs, and AESIs Collected Through Day 451
Timeframe: AEs: through 90 days post each IMP administration; SAEs, MAAEs, and AESIs: through Day 451
2
(Sub-study) Occurrence of AEs Collected Through 29 Days After IMP Administration. SAEs, MAAEs, and AESIs Collected Through Day 451.
Timeframe: through 29 days post IMP administration (AEs); through Day 451 (SAEs, MAAEs, and AESIs)
3
(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.
Timeframe: at Day 29
4
(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.
Timeframe: at Day 29
5
(Main Cohort) Confirmed Symptomatic COVID-19 Case
Timeframe: at Primary Analysis: average follow-up time of 170 days
6
(Main Cohort) Confirmed Symptomatic COVID-19 Case Attributable to Matched Variants