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
Date Written: August 20, 2020
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
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