Effect of Swine Glyco-humanized Polyclonal Neutralizing Antibody on Survival and Respiratory Failure in Patients Hospitalized With Severe COVID-19: A Randomized, Placebo-Controlled Trial

被引:0
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作者
Gaborit, Benjamin [1 ,2 ,17 ]
Vanhove, Bernard [3 ]
Lacombe, Karine [4 ]
Guimard, Thomas [5 ]
Hocqueloux, Laurent [6 ]
Perrier, Ludivine [7 ]
Dubee, Vincent [8 ,9 ]
Ferre, Virginie
Bressollette, Celine [10 ]
Josien, Regis [2 ,11 ]
Le Thuaut, Aurelie [7 ,12 ]
Vibet, Marie-Anne [7 ,12 ]
Jobert, Alexandra [7 ,13 ]
Dailly, Eric [14 ]
Ader, Florence [15 ,16 ]
Brouard, Sophie [2 ]
Duvaux, Odile [3 ]
Raffi, Francois [1 ,17 ]
机构
[1] Nantes Univ, Dept Infect Dis, CHU Nantes, INSERM, Nantes, France
[2] Nantes Univ, Ctr Res Transplantat & Translat Immunol, CHU Nantes, INSERM, Nantes, France
[3] Xenothera, Nantes, France
[4] Sorbonne Univ, Hop St Antoine, Inst Pierre Louis Epidemiol & Sante Publ, Serv Malad Infect & Trop, Paris, France
[5] Ctr Hosp Roche Yon, Infect Dis & Emergency Dept, Roche Yon, France
[6] CHU Orleans, Dept Infect Dis, Orleans, France
[7] Nantes Univ, Sponsor Dept, CHU Nantes, Direct Rech & Innovat, Nantes, France
[8] Ctr Hosp Univ Angers, Serv Malad Infect & Trop, Angers, France
[9] Univ Angers, Nantes Univ, INSERM, Immunol & New Concepts ImmunoTherapy,INCIT, Angers, France
[10] 10Nantes Univ, Virol Lab, CHU Nantes, Nantes, France
[11] Nantes Univ, CHU Nantes, Lab Immunol, CIMNA, Nantes, France
[12] Nantes Univ, CHU Nantes, Plateforme Methodol & Biostat, Direct Rech & Innovat, Nantes, France
[13] Nantes Univ, CHU Nantes, UMR MethodS Patients Ctr Outcomes & Hlth Res 1246, SPHERE, Nantes, France
[14] Nantes Univ, Clin Pharmacol Dept, CHU Nantes, Nantes, France
[15] Univ Lyon, Univ Claude Bernard Lyon 1, Ecole Normale Super Lyon, Ctr Int Rech Infectiol CIRI,UMR5308,Inserm 1111, Lyon, France
[16] Hosp Civils Lyon, Dept Malad Infect & Trop, Lyon, France
[17] Hotel Dieu Univ Hosp, Infect Dis Dept, 1 Pl Alexis Ricordeau, F-44000 Nantes, France
来源
OPEN FORUM INFECTIOUS DISEASES | 2023年 / 10卷 / 11期
关键词
SARS-CoV-2; XAV-19; clinical trial; polyclonal glyco-humanized anti-SARS-CoV-2 antibody;
D O I
10.1093/ofid/ofad525
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background. We evaluated the safety and efficacy of XAV-19, an antispike glyco-humanized swine polyclonal neutralizing antibody in patients hospitalized with severe coronavirus disease 2019 (COVID-19).Methods. This phase 2b clinical trial enrolled adult patients from 34 hospitals in France. Eligible patients had a confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 within 14 days of onset of symptoms that required hospitalization for low-flow oxygen therapy (<6 L/min of oxygen). Patients were randomly assigned to receive a single intravenous infusion of 2 mg/kg of XAV-19 or placebo. The primary end point was the occurrence of death or severe respiratory failure between baseline and day 15.Results. Between January 12, 2021, and April 16, 2021, 398 patients were enrolled in the study and randomly assigned to XAV-19 or placebo. The modified intention-to-treat population comprised 388 participants who received full perfusion of XAV-19 (199 patients) or placebo (189 patients). The mean (SD) age was 59.8 (12.4) years, 249 (64.2%) individuals were men, and the median time (interquartile range) from symptom onset to enrollment was 9 (7-10) days. There was no statistically significant decrease in the cumulative incidence of death or severe respiratory failure through day 15 in the XAV-19 group vs the placebo group (53/199 [26.6%] vs 48/189 [25.4%]; adjusted risk difference, 0.6%; 95% CI, -6% to 7%; hazard ratio, 1.03; 95% CI, 0.64-1.66; P = .90). In the safety population, adverse events were reported in 75.4% of 199 patients in the XAV-19 group and in 76.3% of 190 patients in the placebo group through D29.Conclusions. 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.
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页数:11
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