Rapid Recovery from COVID-19 Respiratory Failure with Comorbidity in 21 Patients Treated with Vasoactive Intestinal Peptide

9 Pages Posted: 4 Aug 2020 Last revised: 20 Aug 2020

See all articles by Jihad G. Youssef

Jihad G. Youssef

Houston Methodist Research Institute

Mukhtar Al-Saadi

Houston Methodist Hospital

Faisal Zahiruddin

Houston Methodist Hospital

Sarah Beshay

Houston Methodist Hospital

Mohammad Bitar

Houston Methodist Hospital

Jonathan Javitt

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

Multiple version iconThere are 2 versions of this paper

Date Written: August 20, 2020

Abstract

Background: Vasoactive Intestinal Peptide (VIP) is known to bind to and protect Alveolar Type II cells by blocking replication of the SARS-CoV-2 virus, inhibiting cytokine synthesis, preventing cytopathy, and upregulating surfactant production. RLF-100™ (aviptadil), a synthetic form of VIP has been granted Fast Track Designation for treating Critical COVID-19 with Respiratory Failure and is currently in phase 2/3 placebo-controlled trials.

Methods: Case series of 21 consecutive patients with Acute Respiratory Failure in Critical COVID-19 and multiple co-morbidities, treated with intravenous VIP. Sixteen patients were treated with mechanical ventilation and five with extracorporeal membrane oxygenation (ECMO).

Results: So far, 19 of 21 patients have survived. Improved radiographic appearance was seen in both lungs of 17 patients and in one lung of 2 patients. A mean 292% increase in PaO2:FiO2 ratio was seen with complete remission from respiratory failure in 9 patients and ongoing improvement in 10. Seven patients were discharged from the hospital, 7 sent to intermediate care, and 5 remain in the ICU. Three of 5 patients on ECMO have been decannulated and two have been discharged. A 75% (95% CI±3%: P<.001) reduction in IL-6 was seen with corresponding decrease in C-reactive protein. A median 4 point reduction in the NIAID Ordinal Scale was observed (P<.01).

Comment: The short term outcomes in these 21 patients represent a dramatic response in patients who are excluded from all other trials of COVID therapeutics. Improvement in radiographic appearance, oxygenation requirement, and inflammatory markers is consistent with in vitro evidence of direct anti-viral effect.

Note: Funding: Funding:Research support was provided by the Cavendish Impact Foundation. Clinical trial funding was provided by Relief Therapeutics Holdings, AG, Geneva, which holds intellectual property related to the pharmacologic use of Aviptadil.

Conflict of Interest: Author JCJ is employed bya pharmaceutical company that is currently conducting clinical trials of RLF-100in patients with COVID-19 and has a financial interest in the outcome of those clinical trials. Author MJJ was paid for medical writing by NeuroRx, Inc. Author JGY has received funding as an investigator for RLF-100 through his institution.

Ethical Approval: Human subjects protection was overseen by the Institutional Review Board (IRB) of the Houston Methodist Hospital.

Keywords: VIP, vasoactive intestinal peptide, aviptadil, SARS-CoV-2, corona virus, COVID-19, respiratory failure, IL6, ARDS

Suggested Citation

Youssef, Jihad G. and Al-Saadi, Mukhtar and Zahiruddin, Faisal and Beshay, Sarah and Bitar, Mohammad and Javitt, Jonathan, Rapid Recovery from COVID-19 Respiratory Failure with Comorbidity in 21 Patients Treated with Vasoactive Intestinal Peptide (August 20, 2020). Available at SSRN: https://ssrn.com/abstract=3665228 or http://dx.doi.org/10.2139/ssrn.3665228

Jihad G. Youssef

Houston Methodist Research Institute ( email )

6670 Bertner Ave
Houston, 77030
United States

Mukhtar Al-Saadi

Houston Methodist Hospital

6621 Fannin St
Houston, TX 77030
United States

Faisal Zahiruddin

Houston Methodist Hospital

6621 Fannin St
Houston, TX 77030
United States

Sarah Beshay

Houston Methodist Hospital

Mohammad Bitar

Houston Methodist Hospital

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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