Jihad Georges Youssef1*, Sami Said2 , George Youssef3 , Matthew J. Javitt4 and Jonathan C. Javitt5,6
Purpose: To assess the clinical safety and possible effectiveness of Vasoactive Intestinal Peptide (VIP) in the treatment of Acute Respiratory Distress Syndrome (ARDS) related to sepsis Methods: Under FDA Investigational New Drug clearance, eight patients with ARDS related to sepsis were treated with 50 pmol/kg/hr-100 pmol/kg/hr of VIP by intravenous infusion for 12 hours. All patients were on mechanical ventilation and full telemetry. Results: No drug related serious adverse events were seen. Hypotension was seen in association with two infusions and diarrhoea in association with one but did not necessitate cessation of therapy. Bigeminy was seen in association with one infusion without sequel. 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, 6 demonstrated successful 30 day survival. The seventh died from a cerebral infarct at day 30, deemed unrelated to treatment with VIP. Serum levels of Tumour 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 treatment results 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 expected 50% survival setting may suggest that VIP shows promise in the treatment of other infectious conditions that damage the pulmonary epithelium, particularly COVID-19
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