During the pandemic, TrialSite has reported multiple times on the potential for NeuroRX’s RLF-100 (aviptadil) currently under investigation and accessible under the U.S. Food and Drug Administration Expanded Access Protocol authorization for respiratory failure related to critical COVID-19. TrialSite reported months ago that at least in a few cases the drug appeared to help patients in a Texas hospital under compassionate use. Now called ZYESAMI™, the company recently announced the initiation of a larger Phase 2/3 clinical trial evaluating if the investigational product can markedly improve conditions for severe COVID-19 patients in partnership with UCI Health of the University of California, Irvine. UCI Health was a key site in the recently completed NeuroRX–sponsored study for intravenous administration in patients with Critical COVID-19 Respiratory Failure. This study’s mission: determine if this drug that has evidenced significant efficacy can reproduce results at the earlier (Severe) stage of COVID-19 and hence reduce the likelihood of progression to Critical COVID-19 with respiratory failure: the predominant cause of death.
Doctors report that the SARS-Cov-2 virus attacks targeted cells in the lungs that serve to actually transmits oxygen. The hope here is that the novel investigational drug aviptadil (ZYESAMI™) can serve to protect these vulnerable cells and hence reduce disease progression that can lead to death.
Showcase by NBC Los Angeles recently, UCI Health takes a leading role in this study led by Dr. Richard Lee and team here in Southern California and other sites.
The drug will be tested on a total of 144 patients at a number of trial sites including UCI Health. With a goal of keeping patients out of emergency rooms, or on a ventilator. On the recent local media newscast, Dr. Richard Lee noted, “Patients with COVID-19 have very low oxygen levels and we’re hoping that this drug can have a beneficial effect on patient’s lungs to improve their oxygenation.”
This study (NCT04360096) includes patients with moderate and severe COVID-19 by FDA definition who haven’t yet developed respiratory failure and who can be treated with nebulized RLF-100 (aviptadil, a synthetic version of Vasoactive Intestinal Polypeptide or VIP) 100 μg 3x daily plus Standard of Care vs. placebo plus Standard of Care using an FDA 501(k) cleared mesh nebulizer.
The study sponsor and team seek to measure if the study drug can reduce progression to severity in COVID-19 patients over a 28 day period. Secondary outcomes include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance and levels of TNFα IL-6 and other cytokines.
The study commences January 2021 and runs through till Sept. 2021.
NeuroRX has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop a drug for suicidal bipolar depression called NRX-101, currently in Phase 3 trials. Its work with RLF-100 (licensed from Relief Therapeutics) was originally considered for treatment of erectile dysfunction. The U.S. and Israeli-based biotech NeuroRX owns the rights to the drug in the United States. The U.S. FDA granted a fest-track designation to RLF-100 for treatment of respiratory distress in COVID-19. By September, 2020 NeuroRX submitted a request for Emergency Use Authorization in the USA for its use in patients in intensive care. TrialSite has reported on positive results at hospitals in Texas.
Call to Action: Those residing in or near Orange County, CA, that have a loved one in moderate to critical care that meet the inclusion criteria should consider this trial.