Treatment of Sepsis-related Acute Respiratory Distress Syndrome with Vasoactive Intestinal Peptide

11 Pages Posted: 7 Aug 2020 Last revised: 19 Aug 2020

See all articles by Jihad G. Youssef

Jihad G. Youssef

Houston Methodist Research Institute

Sami Said

State University of New York (SUNY), Stony Brook (desceased)

George Youssef

University of Houston

Matthew J. Javitt

New York University (NYU) - Langone Medical Center

Jonathan Javitt

Johns Hopkins School of Medicine; Potomac Institute for Policy Studies; NeuroRx

Date Written: July 29, 2020

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.

Note: Funding: Funding for the research was provided to Prof. Sami Said by the National Institutes of Healthgrant HL-55849 and postdoctoral scholarship funding from the Egyptian Ministry of Higher Education. Support for this publication was provided by the Cavendish Impact Foundation and Relief Therapeutics Holdings, AG.

Conflict of Interest: Author JCJ is employed by NeuroRx, Inc., a pharmaceutical company that is developing VIP for human use together with Relief Therapeutics Holdings, AG. Author MCJ received compensation for medical writing.

Conflict of Interest: Human subjects were treated pursuant to IND 52,088 under a protocol approved by the Institutional Review Board of State University of New York Health Sciences Center, Stony Brook, NY.

Registration: This clinical trial was registered with www.clinicaltrials.gov under NCT00004494. Trial was registered before the first patient was enrolled.

Keywords: ARDS, VIP, Aviptadil, RLF-100, Acute Respiratory Distress Syndrome, Sepsis

Suggested Citation

Youssef, Jihad G. and Said, Sami and Youssef, George and Javitt, Matthew J. and Javitt, Jonathan, Treatment of Sepsis-related Acute Respiratory Distress Syndrome with Vasoactive Intestinal Peptide (July 29, 2020). Available at SSRN: https://ssrn.com/abstract=3662952 or http://dx.doi.org/10.2139/ssrn.3662952

Jihad G. Youssef

Houston Methodist Research Institute ( email )

6670 Bertner Ave
Houston, 77030
United States

Sami Said

State University of New York (SUNY), Stony Brook (desceased)

NY
United States

George Youssef

University of Houston ( email )

4800 Calhoun Road
Houston, TX 77204
United States

Matthew J. Javitt

New York University (NYU) - Langone Medical Center

20 Cooper Square 3rd Floor
New York, NY 10003-711
United States

Jonathan Javitt (Contact Author)

Johns Hopkins School of Medicine ( email )

Baltimore, MD

Potomac Institute for Policy Studies ( email )

901 N. Stuart Street
Suite 200
Arlington, VA 22203
United States

NeuroRx ( email )

NeuroRx, Inc.
913 N. Market Street
Wilmington, DE 19801
United States

HOME PAGE: http://www.neurorxpharma.com

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