CONCLUSION - GAME CHANGER
Conclusion:
The rapid clinical improvement seen in these six patients treated with intravenous RLF-100 (Aviptadil), is consistent
with the finding that VIP not only blocks viral replication in the pulmonary epithelium but creates a “bystander effect”
whereby nearby monocytes secrete soluble antiviral agents to further protect ATII cells, blocks cytokine storm, and
improves oxygenation in a lung that is under attack by the SARS-CoV-2 virus. This highly specific role of VIP in the
lung may be key to combating the lethal effects of SARS-CoV-2 infection. A randomized prospective trial is
underway, which will attempt to demonstrate that intravenous RLF-100 improves survival, oxygenation, and clinical
course of Critical COVID-19 with respiratory failure. The independent Data Monitoring Committee of that trial has
conducted the first unblinded look at the study data and identified no safety signals. Moreover, the DMC has
determined that the study is not futile in its objective to identify a statistically significant difference between aviptadil
and placebo in remission from COVID-19 respiratory failure.
The patients reported here were deemed too ill to be randomized in the ongoing phase 2/3 clinical trial of RLF-100 for
treatment of Critical COVID-19. Yet their clinical course, particularly the rapidity with which resolution in COVID
pneumonitis with improvement in oxygenation and radiographic appearance within days is highly atypical for
COVID-19 and suggests that Aviptadil has substantial potential to demonstrate clinical effectiveness in placebocontrolled trials.
