tetano
Editor, Senior Moderator
Open Forum Infect Dis
. 2023 Oct 20;10(11)
fad525.
doi: 10.1093/ofid/ofad525. eCollection 2023 Nov. 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
Benjamin Gaborit[SUP] 1 2 [/SUP], Bernard Vanhove[SUP] 3 [/SUP], Karine Lacombe[SUP] 4 [/SUP], Thomas Guimard[SUP] 5 [/SUP], Laurent Hocqueloux[SUP] 6 [/SUP], Ludivine Perrier[SUP] 7 [/SUP], Vincent Dubee[SUP] 8 9 [/SUP], Virginie Ferre[SUP] 10 [/SUP], Celine Bressollette[SUP] 10 [/SUP], Régis Josien[SUP] 2 11 [/SUP], Aurélie Le Thuaut[SUP] 7 12 [/SUP], Marie-Anne Vibet[SUP] 7 12 [/SUP], Alexandra Jobert[SUP] 7 13 [/SUP], Eric Dailly[SUP] 14 [/SUP], Florence Ader[SUP] 15 16 [/SUP], Sophie Brouard[SUP] 2 [/SUP], Odile Duvaux[SUP] 3 [/SUP], François Raffi[SUP] 1 [/SUP]; POLYCOR study group
Collaborators, Affiliations
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.
Keywords: SARS-CoV-2; XAV-19; clinical trial; polyclonal glyco-humanized anti-SARS-CoV-2 antibody.
. 2023 Oct 20;10(11)
fad525.doi: 10.1093/ofid/ofad525. eCollection 2023 Nov. 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
Benjamin Gaborit[SUP] 1 2 [/SUP], Bernard Vanhove[SUP] 3 [/SUP], Karine Lacombe[SUP] 4 [/SUP], Thomas Guimard[SUP] 5 [/SUP], Laurent Hocqueloux[SUP] 6 [/SUP], Ludivine Perrier[SUP] 7 [/SUP], Vincent Dubee[SUP] 8 9 [/SUP], Virginie Ferre[SUP] 10 [/SUP], Celine Bressollette[SUP] 10 [/SUP], Régis Josien[SUP] 2 11 [/SUP], Aurélie Le Thuaut[SUP] 7 12 [/SUP], Marie-Anne Vibet[SUP] 7 12 [/SUP], Alexandra Jobert[SUP] 7 13 [/SUP], Eric Dailly[SUP] 14 [/SUP], Florence Ader[SUP] 15 16 [/SUP], Sophie Brouard[SUP] 2 [/SUP], Odile Duvaux[SUP] 3 [/SUP], François Raffi[SUP] 1 [/SUP]; POLYCOR study group
Collaborators, Affiliations
- PMID: 37942459
- PMCID: PMC10629360
- DOI: 10.1093/ofid/ofad525
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.
Keywords: SARS-CoV-2; XAV-19; clinical trial; polyclonal glyco-humanized anti-SARS-CoV-2 antibody.