Sabizabulin benefit in hospitalized COVID patients observed early in the disease course

Sabizabulin benefit in hospitalized COVID patients observed early in the disease course

WASHINGTON. The investigational agent sabizabulin reduced the risk of mortality in hospitalized COVID-19 patients receiving only supplemental oxygen at the time of admission, based on a subgroup analysis of a phase III trial.

Of 88 patients with a documented comorbidity who also required oxygen by mask or nasal cannulas (a World Health Organization (WHO) ordinal scale score of 4), deaths were significantly fewer among those receiving oral sabizabulin compared with those who received placebo (5.2% vs. 27.6%; P=0.0090), reported Paula Skarda, MD, of Regions Hospital in St. Paul, Minn.

Patients assigned to sabizabulin also experienced significant reductions in length of hospital stay (13 vs. 24 days with placebo) as well as days spent in the intensive care unit (4 vs. 17 days) or on a ventilator (3 vs. 17 days).

“Overall, this analysis suggests that the antiviral and anti-inflammatory actions of sabizabulin contribute early to the prevention of progression of COVID-19 to acute respiratory distress syndrome. [ARDS] and death,” Skarda said during his presentation at WeekID.

The findings come on the heels of a intermediate analysis of the entire trial population, which included patients with a WHO score of 4 to 6, showed a 51.6% relative reduction in 60-day mortality with oral microtubule disruptor. an fda prevention committee is scheduled to meet next month to discuss whether the data is sufficient to support the emergency use of sabizabulin in moderate to severe COVID-19 patients at high risk for ARDS.

However, not everyone at IDWeek was convinced by the results, with some attendees suggesting that patient selection may have played a role in the large mortality benefit seen in the trial.

“If you look at mortality with COVID right now, it’s extremely low, so to me, if you have high mortality, you’re not choosing patients well,” said session co-moderator Adarsh ​​Bhimraj, MD. , of Houston Methodist Hospital, said medpage today.

“This is just one trial, so we need to see these results replicated in other populations,” Bhimraj cautioned. “The skepticism expressed by the audience here is well founded.”

Skarda reported outcomes in 88 patients in the international, double-blind, randomized trial who had a WHO ordinal scale score of 4, who had documented comorbidity, and for whom all vital statistics were known. This included 59 patients assigned to daily sabizabulin and 29 to placebo, with treatment administered alongside standard of care for 21 days or until discharge.

Comorbidities (a requirement for enrollment in those with a WHO score of 4) included asthma, chronic lung disease, diabetes, hypertension, severe obesity, advanced age, or an immunocompromised condition, among others.

The patients had an average age of 66 to 69 years, their body mass index was approximately 31, and their blood oxygen level was 91% at the time of hospital admission. Regarding COVID-19 vaccination status, less than a third of the sabizabulin group had received at least one dose versus just over a third of the placebo group; more patients assigned to sabizabulin had received three doses or more.

More than 75% of patients received dexamethasone during the course of their treatment, 95% received corticosteroids overall, and approximately 10% received remdesivir (Veklury).

  • Author['full_name']

    ed susman is a freelance medical writer based in Fort Pierce, Florida, USA.

Disclosures

The study was funded by Veru. The co-authors are company employees.

Skarda and Bhimrag declared that they have no relations with the industry.

Leave a Comment