Conclusion:
The significant clinical improvement seen in these 21 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. Most notably, four of the patients included in this series were treated with ECMO,
an end-stage treatment known for mortality of at least 31%, with 53% of patients still on ECMO after 3 weeks.
23 Need
for ECMO represents a treatment-failure event in the phase 2/3 randomized controlled trial of aviptadil.