Browse ATS 2021 Abstracts

HomeProgram ▶ Browse ATS 2021 Abstracts

ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.

Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.

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VIP in the Treatment of Critical COVID-19 Respiratory Failure in Patients with Severe Comorbidities

Session Title
A2478 - VIP in the Treatment of Critical COVID-19 Respiratory Failure in Patients with Severe Comorbidities
Author Block: J. Youssef1, J. Javitt2, P. Lavin3, M. Al-Saadi4, F. Zahiruddin4, S. Beshay4, M. Bitar4, J. A. Kelly4, M. Syed4, G. Youssef5, M. Javitt6; 1Pulmonary/Critical Care, Sleep & Pulmonary Transplant Medicine, Houston Methodist Hospital, Houston, TX, United States, 2Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, Baltimore, MD, United States, 3Boston Biostatistics Research Foundation, Framingham, MA, United States, 4Medicine, Houston Methodist Hospital, Houston, TX, United States, 5Department of Pharmacology & Physiology, GeorgeTown University, Houston, DC, United States, 6Medicine, NYU Langone, Brooklyn, NY, United States.
Importance: There is currently no effective drug for Critical COVID-19 with Respiratory Failure, particularly in highly comorbid patients and mortality is in excess of 30%. Vasoactive Intestinal Peptide (VIP) blocks replication of the SARS-CoV-2 virus, inhibits cytokine synthesis, prevents cytopathy, and upregulates surfactant production in human pulmonary cells.
Objective: To determine the safety and efficacy of intravenous aviptadil (synthetic VIP) for improving survival and recovery from respiratory failure in patients with Critical COVID-19 and severe comorbidity who are ineligible for phase 3 trials of aviptadil.Design: Prospective, open-label, administratively-controlled trial, measuring objective endpoints only. Patients were treated in June/July 2020 and followed for 60 days or more post ICU admission.Setting: Intensive care unit and step down units of a quaternary care hospital.Participants: 21 consecutively admitted patients with Critical COVID-19, treated with intravenous aviptadil, compared to all patients with comparable comorbidity (n=24),ICU admission sequential organ failure assessment (SOFA) score, Rothman index and WHO ordinal scale from the same ICU, treated by the same clinical team, in the same time-frame who received maximal standard of care (SOC).Intervention: 3 successive 12-hour intravenous infusions of aviptadil at 50/100/150 pmol/kg/hr.Main Outcome Measures: Survival, Recovery from Respiratory Failure, WHO 10 point ordinal scale.Results: Nineteen of 21 patients survived to day 28 in the aviptadil-treated group compared to 4 of 24 control patients (90% vs 17%; P<.0001). Kaplan-Meier analysis demonstrates a 9-fold advantage in probability of survival (Hazard Ratio 0.113; 95% CL 0.037, 0.343). A similar 9-fold advantage was seen in cumulative probability of Recovery from Respiratory Failure (Hazard ratio: 0.115; 95% CL: 0.0254, 0.5219). A mean 6.1 point difference in the 10 point WHO Ordinal Scale for COVID-19 was seen between aviptadil-treated patients, who exhibited a 2.6 point mean improvement from time of ICU admission vs. those treated with SOC who exhibited a mean 3.5 point mean decrement (Wilcoxon rank sum: P<.001). Improved radiographic appearance was seen in both lungs of 17 patients and in one lung of 2 treated patients. Four of 5 aviptadil-treated patients initially on Extracorporeal Membrane Oxygenation (ECMO) have been decannulated, compared to 3 of 13 ECMO-treated controls (80% vs. 23%;P=.045). A 75% (95% CI±3%: P<.001) reduction in IL-6 was seen.Comment: A dramatic multi-dimensional treatment effect was observed, consistent with FDA and ICH-10 guidance for acceptance of externally-controlled, open-label trials in high-lethality conditions.