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Oral Sabizabulin for High-Risk, Hospitalized Adults with Covid-19: Interim Analysis.
Barnette, K Gary; Gordon, Michael S; Rodriguez, Domingo; Bird, T Gary; Skolnick, Alan; Schnaus, Michael; Skarda, Paula K; Lobo, Suzana; Sprinz, Eduardo; Arabadzhiev, Georgi; Kalaydzhiev, Petar; Steiner, Mitchell.
Afiliación
  • Barnette KG; Veru, Inc., Miami.
  • Gordon MS; HonorHealth Research Institute, Scottsdale, AZ.
  • Rodriguez D; Veru, Inc., Miami.
  • Bird TG; Veru, Inc., Miami.
  • Skolnick A; Memorial Hermann, Memorial City Medical Center, Houston.
  • Schnaus M; Methodist Hospital, St. Louis Park, MN.
  • Skarda PK; Regions Hospital, St. Paul, MN.
  • Lobo S; Fundação Faculdade Regional de Medicina, São José do Rio Preto, Brazil.
  • Sprinz E; Infectologia, Hospital de Clínicas de Porto Alegre, Centro de Pesquisa Clínica, Porto Alegre, Brazil.
  • Arabadzhiev G; University Multiprofile Hospital for Active Treatment, Zagora, Bulgaria.
  • Kalaydzhiev P; University Multiprofile Hospital for Active Treatment, Sofia, Bulgaria.
  • Steiner M; Veru, Inc., Miami.
NEJM Evid ; 1(9): EVIDoa2200145, 2022 Sep.
Article en En | MEDLINE | ID: mdl-38319812
ABSTRACT

BACKGROUND:

Sabizabulin is an oral, novel microtubule disruptor that has dual antiviral and anti-inflammatory activities in preclinical models.

METHODS:

A randomized, multicenter placebo-controlled phase 3 clinical trial was conducted with hospitalized patients with moderate to severe Covid-19 who were at high risk for acute respiratory distress syndrome (ARDS) and death. Patients were randomly assigned (21) to 9 mg of oral sabizabulin or placebo daily (up to 21 days). The primary end point was all-cause mortality up to day 60. Key secondary end points were days in the intensive care unit (ICU), days on mechanical ventilation, and days in the hospital.

RESULTS:

A total of 204 patients were randomly assigned to treatment 134 to sabizabulin and 70 to placebo. Baseline characteristics were similar. Sabizabulin superiority was demonstrated by a planned interim analysis for the first 150 randomized patients. Sabizabulin treatment resulted in a 24.9 percentage point absolute reduction and a 55.2% relative reduction in deaths compared with placebo (odds ratio, 3.23; 95% CI confidence interval, 1.45 to 7.22; P=0.0042). The mortality rate was 20.2% (19 of 94) for sabizabulin versus 45.1% (23 of 51) for placebo. For the key secondary end points, sabizabulin treatment resulted in a 43% relative reduction in ICU days (P=0.0013), a 49% relative reduction in days on mechanical ventilation (P=0.0013), and a 26% relative reduction in days in the hospital (P=0.0277) versus placebo. Adverse and serious adverse events were lower in the sabizabulin group compared with the placebo group.

CONCLUSIONS:

Sabizabulin treatment resulted in a 24.9% absolute reduction in deaths compared with placebo in hospitalized patients with moderate to severe Covid-19 at high risk for ARDS and death, with a lower incidence of adverse and serious adverse events compared with placebo. (Funded by Veru, Inc.; ClinicalTrials.gov number, NCT04842747.)
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: COVID-19 Tipo de estudio: Clinical_trials / Etiology_studies / Risk_factors_studies Límite: Adult / Humans Idioma: En Revista: NEJM Evid Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: COVID-19 Tipo de estudio: Clinical_trials / Etiology_studies / Risk_factors_studies Límite: Adult / Humans Idioma: En Revista: NEJM Evid Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos