The Use of IV Vasoactive Intestinal Peptide (Aviptadil) in Patients With Critical COVID-19 Respiratory Failure: Results of a 60-Day Randomized Controlled Trial

 

by Youssef, Jihad Georges; Lavin, Philip; Schoenfeld, David A.; Lee, Richard A.; Lenhardt, Rainer; Park, David J.; Fernandez, Javier Perez; Morganroth, Melvin L.; Javitt, Jonathan C.; Jayaweera, Dushyantha 

 

Critical Care Medicine: August 31, 2022 - Volume - Issue - 10.1097

 

Objectives: 

Respiratory failure is a lethal complication of COVID-19 that has remained resistant to drug therapy. Vasoactive intestinal peptide (VIP) is shown in nonclinical studies to upregulate surfactant production, inhibit cytokine synthesis, prevent cytopathy, and block replication of the severe acute respiratory syndrome coronavirus 2 virus in pulmonary cells. The study aims to determine whether Aviptadil (synthetic VIP) can improve survival and recovery in patients with COVID-19 respiratory failure compared with placebo and demonstrate biological effects in such patients.

Design: 

A multicenter, placebo-controlled trial.

Setting: 

Ten U.S. hospitals: six tertiary-care hospitals and four community hospitals.

Patients: 

A total of 196 patients with COVID-19 respiratory failure.

Interventions: 

Participants were randomized 2:1 to receive 3 days of IV Aviptadil or placebo.

Measurements and Main Results: 

The primary end point (alive and free from respiratory failure at day 60) did not reach statistical significance (odds ratio [OR], 1.6; 95% CI, 0.86–3.11) for patients treated with Aviptadil when controlling for baseline ventilation status as prespecified in the protocol. There was, however, a statistically significant two-fold odds of improved survival (OR, 2.0; 95% CI, 1.1–3.9) at 60 days (p = 0.035). There was significant improvement in respiratory distress ratio and reduced interleukin 6 cytokine release (p = 0.02) by day 3.

Subgroup analysis identified a statistically significant likelihood of achieving primary end point among those treated with high-flow nasal oxygen at baseline (p = 0.039). Subjects on mechanical ventilation also experienced a 10-fold increased odds of survival with drug versus placebo (p = 0.031).

Conclusions: 

The primary end point did not reach statistical significance, indicating that there was no difference between Aviptadil versus placebo. However, Aviptadil improves the likelihood of survival from respiratory failure at day 60 in critical COVID-19 across all sites of care. Given the absence of drug-related serious adverse events and acceptable safety profile, we believe the benefit versus risk for the use of Aviptadil is favorable for patient treatment.

Critical care response to a hospital outbreak of the 2019-nCoV infection in Shenzhen, China

Critical care response to a hospital outbreak of the 2019-nCoV infection in Shenzhen, China

by Yong Liu, Jinxiu Li and Yongwen Feng 

Critical Care volume 24, Article number: 56 (2020)

Beginning at early December 2019, there is an outbreak of a novel 2019-nCoV in Wuhan, China. Then, Public Health Emergency of International Concern (PHEIC) was declared on 30 January 2020, by the World Health Organization (WHO) Emergency Committee. The 2019-nCoV pandemic could lead to an influx of critically ill into the already strained hospital systems in mainland China. Dealing with the pandemic requires a robust hospital- and city-wide command and control structure that could make quick and informed decisions among Chinese hospitals. We recommend that a proper plan can enable the local government, healthcare systems, hospitals, and healthcare workers to better cope with such public eventuality. The response should be flexible and adjustable according to the size of the population impacted.

Novel coronavirus infection during the 2019–2020 epidemic: preparing intensive care units—the experience in Sichuan Province, China

Novel coronavirus infection during the 2019–2020 epidemic: preparing intensive care units—the experience in Sichuan Province, China

By Xuelian Liao, Bo Wang & Yan Kang 

Intensive Care Medicine volume 46, pages 357–360(2020)

Up to 31 January 2020, there have been 9811 officially reported confirmed cases of 2019-novel coronavirus (nCoV) infection in China since the epidemic began in December 2019 (updated data available at https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6).

With the rapid transmission, the epidemic has spread throughout the country, and 177 cases have been reported in Sichuan Province. As nCoV infection is a highly contagious disease with high mortality (3–15%) [1,2,3] and West China Hospital (WCH) is the largest hospital in the southwest of China and the referral medical center in Sichuan Province, it is our responsibility to prepare for admission of additional critically ill patients as a matter of emergency. We have held several expert meetings and have reviewed the related literature to develop a plan to respond to the epidemic [4, 5]. The purpose of the plan is to enable us to provide the maximum level of care to critically ill patients while ensuring the protection of medical staff…