What side effects are associated with this type of intervention?

Monoclonal antibodies, such as those being studied in the trial AZD3152, are designed to neutralize SARS-CoV-2 variants. Common side effects of monoclonal antibody treatments for COVID-19 include infusion-related reactions such as fever, chills, nausea, headache, and rash. Some patients may also experience more severe allergic reactions, though these are less common. It is important to monitor for any adverse effects during and after administration.

What prior FDA approvals exist?

Several monoclonal antibodies have received emergency use authorization (EUA) by the FDA for the early treatment of mild to moderate COVID-19, including sotrovimab, BRII-196 plus BRII-198, and casirivimab and imdevimab. These treatments were designed to neutralize SARS-CoV-2, but many have faced challenges due to the emergence of new variants. The trial AZD3152 aims to develop a monoclonal antibody with broad neutralizing activity against known SARS-CoV-2 variants, continuing the effort to provide effective treatments amidst evolving viral strains.

What other types of research exist?

Promising alternatives to AZD3152 for treating coronavirus patients include sotrovimab (VIR-7831), which has shown efficacy against multiple variants including Omicron, and the combination of nirmatrelvir and ritonavir, which has demonstrated effectiveness in reducing severe outcomes in COVID-19 patients. Additionally, new monoclonal antibodies like AZD5156, a combination of AZD3152 and AZD1061, are being evaluated for their broad neutralizing activity and could be potential alternatives.

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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.

Summary

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.

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.

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.

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.

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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

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

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

Group V: Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - AZD5156Experimental Treatment1 Intervention

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

Group X: Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal - PlaceboPlacebo Group1 Intervention

Group XI: Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - PlaceboPlacebo Group1 Intervention

Group XII: Parent study Main Cohort - PlaceboPlacebo Group1 Intervention

Group XIII: Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - PlaceboPlacebo Group1 Intervention

Group XIV: Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - PlaceboPlacebo Group1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for COVID-19 include antiviral medications, monoclonal antibodies, and supportive care. Antiviral medications, such as remdesivir, inhibit viral replication by targeting viral RNA polymerase. Monoclonal antibodies, like AZD3152, are designed to neutralize the virus by binding to the spike protein of SARS-CoV-2, preventing it from entering human cells. This is particularly important for COVID-19 patients as it can reduce viral load, limit disease progression, and provide protection against multiple variants. Supportive care, including oxygen therapy and antipyretics, helps manage symptoms and improve patient outcomes.

Network pharmacology-based analysis of Zukamu granules for the treatment of COVID-19.Synergistic antiviral effect of hydroxychloroquine and azithromycin in combination against SARS-CoV-2: What molecular dynamics studies of virus-host interactions reveal.