XAV-19 / LFB SA, Xenothera 
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  • ||||||||||  XAV-19 / LFB SA, Xenothera
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  EUROXAV: Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19 (clinicaltrials.gov) -  Jan 23, 2023   
    P2/3,  N=290, Terminated, 
    Among patients hospitalized with COVID-19 requiring low-flow oxygen therapy, treatment with a single intravenous dose of XAV-19, compared with placebo, did not show a significant difference in terms of disease progression at day 15. N=722 --> 290 | Trial completion date: Apr 2022 --> Nov 2022 | Recruiting --> Terminated | Trial primary completion date: Apr 2022 --> Nov 2022; Lack of recruitment
  • ||||||||||  XAV-19 / LFB SA, Xenothera
    Trial completion, Trial completion date, Trial primary completion date:  POLYCOR: Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia (clinicaltrials.gov) -  Mar 25, 2022   
    P2,  N=416, Completed, 
    N=722 --> 290 | Trial completion date: Apr 2022 --> Nov 2022 | Recruiting --> Terminated | Trial primary completion date: Apr 2022 --> Nov 2022; Lack of recruitment Active, not recruiting --> Completed | Trial completion date: Dec 2021 --> Aug 2021 | Trial primary completion date: Dec 2021 --> May 2021
  • ||||||||||  XAV-19 / LFB SA, Xenothera
    Journal:  XAV-19, a Swine Glyco-Humanized Polyclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Domain, Targets Multiple Epitopes and Broadly Neutralizes Variants. (Pubmed Central) -  Jan 4, 2022   
    P2, P2/3
    XAV-19 is currently evaluated in patients hospitalized for COVID-19-induced moderate pneumonia in phase 2a-2b (NCT04453384) where safety was already demonstrated and in an ongoing 2/3 trial (NCT04928430) to evaluate the efficacy and safety of XAV-19 in patients with moderate-to-severe COVID-19. Owing to its polyclonal nature and its glyco-humanization, XAV-19 may provide a novel safe and effective therapeutic tool to mitigate the severity of coronavirus disease 2019 (COVID-19) including the different variants of concern identified so far.
  • ||||||||||  XAV-19 / LFB SA, Xenothera
    Trial completion date, Trial primary completion date:  EUROXAV: Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19 (clinicaltrials.gov) -  Nov 29, 2021   
    P2/3,  N=722, Recruiting, 
    Owing to its polyclonal nature and its glyco-humanization, XAV-19 may provide a novel safe and effective therapeutic tool to mitigate the severity of coronavirus disease 2019 (COVID-19) including the different variants of concern identified so far. Trial completion date: Aug 2021 --> Apr 2022 | Trial primary completion date: Aug 2021 --> Apr 2022
  • ||||||||||  XAV-19 / LFB SA, Xenothera
    Journal:  High neutralizing potency of swine glyco-humanized polyclonal antibodies against SARS-CoV-2. (Pubmed Central) -  Jun 16, 2021   
    We also found that pig GH-pAb Fc domains fail to interact with human Fc receptors, thereby avoiding macrophage dependent exacerbated inflammatory responses and a possible antibody-dependent enhancement (ADE). These data and the accumulating safety advantages of using GH-pAbs in humans warrant clinical assessment of XAV-19 against COVID-19.