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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
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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
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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
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Clinical, P2a data, PK/PD data, Journal: Pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal anti-SARS-CoV-2 antibody, for COVID-19-related moderate pneumonia: a randomized, double-blind, placebo-controlled, phase IIa study. (Pubmed Central) - Aug 25, 2021 P2 Single intravenous dose of 2mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability. Trial registration: ClinicalTrials.gov Identifier: NCT04453384.
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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.
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