AZD5156 / AstraZeneca - LARVOL DELTA

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study (clinicaltrials.gov) - P2/3 | N=3882 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

AZD3152 neutralizes SARS-CoV-2 historical and contemporary variants and is protective in hamsters and well tolerated in adults. (PubMed, Sci Transl Med) - P2/3 | "In the phase 1 sentinel safety cohort of the ongoing SUPERNOVA study (ClinicalTrials.gov: NCT05648110), a single 600-mg intramuscular injection of AZD5156 (containing 300 mg each of AZD3152 and cilgavimab) was well tolerated in adults through day 91. Observed serum concentrations of AZD3152 through day 91 were similar to those observed with cilgavimab and consistent with predictions for AZD7442, a SARS-CoV-2-neutralizing antibody combination of cilgavimab and tixagevimab, in a population pharmacokinetic model. On the basis of its pharmacokinetic characteristics, AZD3152 is predicted to provide durable protection against symptomatic coronavirus disease 2019 caused by susceptible SARS-CoV-2 variants, such as JN.1, in humans."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study (clinicaltrials.gov) - P2/3 | N=3882 | Active, not recruiting | Sponsor: AstraZeneca | Trial primary completion date: Sep 2023 ➔ Mar 2024

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Sentinel cohort safety of AZD5156/AZD3152 from the phase 1/3 SUPERNOVA trial for COVID-19 prevention in participants with immune impairment (ECCMID 2024) - No abstract available

Clinical • P1 data • Infectious Disease • Novel Coronavirus Disease

Emerging anti-spike monoclonal antibodies against SARS-CoV-2. (PubMed, Expert Opin Biol Ther) - "Strategies to potentially mitigate this are discussed. Based on prior successful experience, immunocompromised patients will certainly benefit from the utilization of mAbs for the prevention and treatment of COVID-19; thus, we need to design potential interventions to ensure the sustained activity of these agents."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study (clinicaltrials.gov) - P2/3 | N=4038 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study (clinicaltrials.gov) - P2/3 | N=3706 | Recruiting | Sponsor: AstraZeneca | Phase classification: P3 ➔ P2/3

Phase classification • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Solid Tumor • CD4

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) (clinicaltrials.gov) - P3 | N=3256 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting | N=1244 ➔ 3256

Enrollment change • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Solid Tumor

A phase I/III study to assess pre-exposure prophylaxis of AZD5156 in immunocompromised individuals (clinicaltrialsregister.eu) - P3 | N=1244 | Ongoing | Sponsor: AstraZeneca AB

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Solid Tumor

SUPERNOVA: A Study for Immunocompromised Patients for Pre Exposure Prophylaxis of COVID-19 With AZD5156. (clinicaltrials.gov) - P3 | N=1244 | Not yet recruiting | Sponsor: AstraZeneca

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Solid Tumor