Leticia Pacheco’s fiancé is battling for his life against COVID-19. The family has heard that Aviptadil (RLF-100), not yet approved by the U.S. Food and Drug Administration (FDA), but purported to work, is currently an investigational drug used in clinical trials at the University of California, Irvine, the Miller School of Medicine, University of Miami, University of Louisville and Houston Methodist Hospital. Although still under investigation, the drug is available to those critically ill, and it also received Fast Track Designation from the FDA in July.
TrialSite reported that it was contacted by family members of patients with dire situations in both San Antonio and Odessa, Texas. Similar to this situation, family members sought access to RLF-100. Those families in San Antonio and elsewhere in Texas are hearing about success stories at Houston Methodist.
Ms. Leticia Pacheco is trying to save her future husband but hasn’t been able to secure the medication at the hospital where her fiancé is currently located, Baptist Medical Center. She is trying to get this hospital to use RLF-100. Baptist Health System responded via email by declaring they could not comment on this particular case and noted, “its doctors rely on federal agencies for guidance on new treatments.” This same patient was in touch with TrialSite weeks ago, and the situation can only become more dire as the fiancé commented, “We’re just trying to give Joe a fighting chance.”
The Drug Maker
The drug sponsor is NeuroRx, who develops and distributes the drug for Relief Therapeutics in Switzerland. NeuroRx reported to Fox San Antonio that the drug can be used at other medical centers, such as the current hospital, as long as a certified critical care doctor enrolls as an investigator in their expanded access program: they must complete some documentation. According to the NeuroRx website, “This will take about an hour of your doctor’s time to complete.” NeuroRx notes the drug is only available for doctors in the “Intensive Care setting,” and they only work at this point with physicians who are experts at critical care as investigations based on their “expanded use protocol.”
Baptist Medical Center in San Antonio started back in 1903 when 30 physician members of the Bexar County Medical Society joined with more than two dozen business people and professionals to organize San Antonio Associated Charities. Over 100 years later, the hospital includes acute care hospitals, urgent care clinics, imaging centers, and freestanding emergency departments.
Part of the Baptist Health System in San Antonio, Texas, the provider has a level IV trauma center and 623 beds.
Call to Action: TrialSite hopes the hospital moves to secure the study drug as part of the expanded access in the hopes of improving the odds of saving a life. See the link.