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All Studies   Meta Analysis    Recent:   

Oral Sabizabulin for High-Risk, Hospitalized Adults with Covid-19: Interim Analysis

Barnette et al., NEJM Evidence, doi:10.1056/EVIDoa2200145
Jul 2022  
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0 0.5 1 1.5 2+ Mortality 55% Improvement Relative Risk Ventilation time 49% ICU time 44% Hospitalization time 26% Sabizabulin  Barnette et al.  LATE TREATMENT  DB RCT Is late treatment with antiandrogens beneficial for COVID-19? Double-blind RCT 150 patients in multiple countries (May 2021 - Jan 2022) Lower mortality (p=0.0022) and shorter ventilation (p=0.0013) c19early.org Barnette et al., NEJM Evidence, July 2022 Favors sabizabulin Favors control
7th treatment shown to reduce risk in September 2020
 
*, now known with p = 0.000000056 from 49 studies.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
RCT with 98 hospitalized moderate/severe patients treated with sabizabulin and 52 control patients, showing lower mortality with treatment. Sabizabulin 9mg for up to 21 days. For more discussion see1-3.
risk of death, 55.2% lower, RR 0.45, p = 0.002, treatment 19 of 94 (20.2%), control 23 of 51 (45.1%), NNT 4.0.
ventilation time, 49.5% lower, relative time 0.51, p = 0.001, treatment 98, control 52.
ICU time, 43.5% lower, relative time 0.56, p = 0.001, treatment 98, control 52.
hospitalization time, 26.0% lower, relative time 0.74, p = 0.03, treatment 98, control 52.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Barnette et al., 6 Jul 2022, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 12 authors, study period 18 May, 2021 - 31 January, 2022. Contact: gbarnette@verupharma.com.
This PaperAntiandrogensAll
Oral Sabizabulin for High-Risk, Hospitalized Adults with Covid-19: Interim Analysis
Ph.D K Gary Barnette, M.D Michael S Gordon, M.D Domingo Rodriguez, T Gary Bird, M.D Alan Skolnick, M.D Michael Schnaus, M.D Paula K Skarda, M.D Suzana Lobo, M.D Eduardo Sprinz, M.D Georgi Arabadzhiev, M.D Petar Kalaydzhiev, M.D Mitchell Steiner
NEJM Evidence, doi:10.1056/evidoa2200145
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 (2:1) 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; P50.0042). 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 (P50.0013), a 49% relative reduction in days on mechanical ventilation (P50.0013), and a 26% relative reduction in days in the hospital (P50.0277) 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.)
Author Affiliations 1 Veru, Inc., Miami 2 HonorHealth Research Institute, Scottsdale, AZ 3 Memorial Hermann, Memorial City Medical Center, Houston
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Late treatment
is less effective
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