Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based upon FIO2 Requirements
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Le résumé fourni par la source
Once a patient has been diagnosed with severe COVID-19 pneumonia, treatment options have limited effectiveness. Opaganib is an oral treatment under investigation being evaluated for treatment of hospitalized patients with severe COVID-19 pneumonia. A randomized, placebo-controlled, double-blind phase 2/3 trial was conducted in 57 sites worldwide from August 2020 to July 2021. Patients received either opaganib (n = 230; 500 mg twice daily) or matching placebo (n = 233) for 14 days. The primary outcome was the proportion of patients no longer requiring supplemental oxygen by day 14. Secondary outcomes included changes in the World Health Organization Ordinal Scale for Clinical Improvement, viral clearance, intubation, and mortality at 28 and 42 days. Pre-specified primary and secondary outcome analyses did not demonstrate statistically significant benefit (except nominally for time to viral clearance). Post-hoc analysis revealed the fraction of inspired oxygen (FIO2) at baseline was prognostic for opaganib treatment responsiveness and corresponded to disease severity markers. Patients with FIO2 levels at or below the median value (≤60%) had better outcomes after opaganib treatment (n = 117) compared to placebo (n = 134). The proportion of patients with ≤60% FIO2 at baseline that no longer required supplemental oxygen (≥24 h) by day 14 of opaganib treatment increased (76.9% vs. 63.4%; nominal p-value = 0.033). There was a 62.6% reduction in intubation/mechanical ventilation (6.84% vs. 17.91%; nominal p-value = 0.012) and a clinically meaningful 62% reduction in mortality (5.98% vs. 16.7%; nominal p-value = 0.019) by day 42. No new safety concerns were observed. While the primary analyses were not statistically significant, post-hoc analysis suggests opaganib benefit for patients with severe COVID-19 requiring supplemental oxygen with an FIO2 of ≤60%. Further studies are warranted to prospectively confirm opaganib benefit in this subpopulation.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based upon FIO2 Requirements
- Date Crossref
- 26/08/2024
- Éditeur
- MDPI AG
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Israel Institute for Biological Research pays non établi dans la noticeStructure de recherche
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Alessandro Manzoni Hospital pays non établi dans la noticeÉtablissement de santé
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Tel Aviv University pays non établi dans la noticeUniversité ou école supérieure
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Wolfson Medical Center Infectious Disease Unit pays non établi dans la noticeÉtablissement de santé
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Hospital de Clínicas de Porto Alegre pays non établi dans la noticeÉtablissement de santé
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Western Galilee Hospital pays non établi dans la noticeÉtablissement de santé
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St. Petersburg State Medical Academy "City Hospital No. 26" pays non établi dans la noticeÉtablissement de santé
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Russian Medical Academy of Continuous Professional Education pays non établi dans la noticeUniversité ou école supérieure
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Ministry of Health of the Russian Federation pays non établi dans la noticeOrganisme public
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City Hospital No. 40 pays non établi dans la noticeÉtablissement de santé
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Research Institute of Emergency Care pays non établi dans la noticeStructure de recherche
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Ospedale Amedeo di Savoia pays non établi dans la noticeÉtablissement de santé
Israel Institute for Biological Research, Alessandro Manzoni Hospital et Tel Aviv University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.