Summary of COVID-19 XAV-19 studies

1. Poulakou et al., XAV-19 a Glyco-Humanized polyclonal antibody targeting SARS-CoV-2 accelerates the recovery of mild to moderate COVID-19 patients and keeps its neutralizing activity against Omicron and its subvariants

279 patient XAV-19 early treatment RCT: 1% higher mortality (p=1) and 34% higher progression (p=0.48).
RCT 293 COVID-19 patients showing no significant difference in the primary endpoint (disease aggravation within 8 days) with XAV-19, a glyco-humanized swine polyclonal antibody. While XAV-19 showed no benefit for patients requiring oxygen therapy, it significantly reduced time to improvement for patients not requiring oxygen (7 days vs 14 days, p=0.0159).
Oct 2023, medRxiv, https://www.medrxiv.org/content/10.1101/2023.10.09.23296726, https://c19p.org/poulakou

2. Gaborit et al., 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

398 patient XAV-19 late treatment RCT: 90% higher mortality (p=0.29), 106% higher ventilation (p=0.03), 5% higher ICU admission (p=0.9), and 5% higher progression (p=0.82).
RCT 398 hospitalized patients with severe COVID-19 requiring low-flow oxygen therapy showing no significant difference in death or respiratory failure through day 15 with XAV-19 (a swine glyco-humanized polyclonal neutralizing antibody) compared to placebo.
Oct 2023, Open Forum Infectious Diseases, https://academic.oup.com/ofid/article/doi/10.1093/ofid/ofad525/7325964, https://c19p.org/gaborit