Evidence map›Paper›PMID 37942459›Full record

ArticleOpen forum infectious diseases2023

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, Bernard Vanhove, Karine Lacombe, Thomas Guimard, Laurent Hocqueloux, Ludivine Perrier, Vincent Dubee, Virginie Ferre, Celine Bressollette, Régis Josien and 9 more

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 46% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 7 institutions in 1 country.

Benjamin GaboritNantes Université, CHU Nantes, INSERM, Department of Infectious Diseases, Nantes, France.ORCID https://orcid.org/0000-0002-6076-9722
Bernard VanhoveXenothera, Nantes, France.
Karine LacombeINSERM, AP-HP, Hôpital Saint-Antoine, Service des Maladies Infectieuses et Tropicales, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Paris, France.
Thomas GuimardInfectious Diseases and Emergency Department, Centre Hospitalier de La Roche sur Yon, La Roche sur Yon, France.
Laurent HocquelouxCHU d'Orléans, Department of Infectious Diseases, Orleans, France.
Ludivine PerrierNantes Université, CHU Nantes, Sponsor Department, Direction de la Recherche et de l'Innovation, Nantes, France.
Vincent DubeeService de Maladies Infectieuses et Tropicales, Centre Hospitalier Universitaire d'Angers, Angers, France.
Virginie FerreNantes Université, CHU Nantes, Virology Laboratory, Nantes, France.
Celine BressolletteNantes Université, CHU Nantes, Virology Laboratory, Nantes, France.
Régis JosienNantes Université, CHU Nantes, INSERM, Center for Research in Transplantation and Translational Immunology, Nantes, France.
Aurélie Le ThuautNantes Université, CHU Nantes, Sponsor Department, Direction de la Recherche et de l'Innovation, Nantes, France.
Marie-Anne VibetNantes Université, CHU Nantes, Sponsor Department, Direction de la Recherche et de l'Innovation, Nantes, France.
Alexandra JobertNantes Université, CHU Nantes, Sponsor Department, Direction de la Recherche et de l'Innovation, Nantes, France.
Eric DaillyNantes Université, CHU Nantes, Clinical Pharmacology Department, Nantes, France.
Florence AderCNRS, UMR5308, Ecole Normale Supérieure de Lyon, Centre International de Recherche en Infectiologie (CIRI), Inserm 1111, Université Claude Bernard Lyon 1, Université Lyon, Lyon, France.
Sophie BrouardNantes Université, CHU Nantes, INSERM, Center for Research in Transplantation and Translational Immunology, Nantes, France.
Odile DuvauxXenothera, Nantes, France.
François RaffiNantes Université, CHU Nantes, INSERM, Department of Infectious Diseases, Nantes, France.
POLYCOR study group
Inserm · FRNantes Université · FRCentre hospitalier universitaire d'Orléans · FRUniversité Claude Bernard Lyon 1 · FRRoche (France) · FRmethodS in Patient-centered outcomes and HEalth ResEarchSciences, Philosophie, Histoire · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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; 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.

Indexed as

clinical trialpolyclonal glyco-humanized anti-SARS-CoV-2 antibodySARS-CoV-2XAV-19

Identifiers

PMID37942459
PMCPMC10629360
OpenAlexW4387803115

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.