Abstract
Purpose: To assess the clinical safety and possible effectiveness of Vasoactive Intestinal Peptide in the treatment of Acute Respiratory Distress Syndrome (ARDS) related to sepsis Methods: Under FDA Investigational New Drug clearance, 8 patients with ARDS related to sepsis were treated with 50 pmole/kg/hr – 100 pmole/kg/hr of Vasoactive Intestinal Peptide by intravenous infusion for 12 hours. All patients were on mechanical ventilation and full telemetery. Results: No drug-related serious adverse events were seen. Hypotension was seen in association with two infusions and diarrhea in association with one, but did not necessitate cessation of therapy. Bigeminy was seen in association with one infusion without sequelae. Seven of eight patients demonstrated a successful course during intensive care and were successfully removed from mechanical ventilation and discharged from intensive care. The eighth patient succumbed to purulent secretions in the lungs. Of those who were discharged from the ICU, six demonstrated successful 30 day survival. The seventh died from a cerebral infract at day 30, deemed unrelated to treatment with VIP. Serum levels of Tumor Necrosis Factor α were obtained in 6 patients at baseline and 24 hours and were seen to decrease with treatment in five patients. Conclusions: Initial clinical results of treatment with VIP in patients with ARDS demonstrated a safety profile consistent with previous studies in normal volunteers. The successful clinical course seen in 7 of 8 patients in the setting of an expected 50% survival may suggest that VIP shows promise in the treatment of other infectious conditions that damage the pulmonary epithelium, particularly COVID-19.
Highlights
The successful clinical course seen in 7 of 8 patients in the setting of an expected 50% survival may suggest that Vasoactive Intestinal Peptide (VIP) shows promise in the treatment of other infectious conditions that damage the pulmonary epithelium, COVID-19
In March 2020, the US Food and Drug Administration cleared the investigational use of RLF-100 (aviptadil: a synthetic form of Vasoactive Intestinal Peptide (VIP)) for the treatment of Critical COVID-19 with Respiratory Failure
Among the evidence of human safety included in the Investigational New Drug (IND) application was a previously unpublished study of patients with Acute respiratory distress syndrome (ARDS) in the setting of sepsis
Summary
In March 2020, the US Food and Drug Administration cleared the investigational use of RLF-100 (aviptadil: a synthetic form of Vasoactive Intestinal Peptide (VIP)) for the treatment of Critical COVID-19 with Respiratory Failure. Among the evidence of human safety included in the Investigational New Drug (IND) application was a previously unpublished study of patients with Acute respiratory distress syndrome (ARDS) in the setting of sepsis. RLF-100 has subsequently been granted a Fast Track Designation by FDA and initial clinical results in the treatment of Critical COVID-19 with Respiratory Failure will shortly be reported. This manuscript reports that prior clinical experience with the use of VIP in ARDS. The clinical course of the treated patients was witnessed by author JGY, who was the primary treating physician for the study
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