PETAL Network session will provide update on ARDS and COVID-19 trials

Robert Duncan Hite, MD

Conducting trials that bridge and impact care across emergency and intensive care is a key goal for the National Heart, Lung, and Blood Institute (NHLBI)-funded Prevention and Early Treatment of Acute Lung Injury (PETAL) Network. The network has been designing and performing innovative clinical trials targeting ARDS treatment and prevention since 2014. 
“Our third update on the PETAL Network to the CHEST attendees will provide the most current information available on completed and ongoing high-impact trials with potential to change clinical practice in ARDS and COVID-19 during the next 1 to 2 years,” said R. Duncan Hite, MD, FCCP. “PETAL emphasizes collaboration between providers who deliver care prior to and after admission to the ICU.”

The latest results of collaborating across departments will be presented in the PETAL Network: 2020 Progress Report on Sunday, October 18, from 7:30 am to 8:30 am CT. The session will be available for on-demand viewing 24 hours later on the virtual CHEST 2020 meeting platform through January 18.

This update will include further analysis and implications for VIOLET, the first completed PETAL trial targeting ARDS prevention.

PETAL also play a key role in three COVID-19 trials—ORCHID, ACTIV-3, and ACTIV-4—plus the pivotal CLOVERS trial of fluids and vasopressors for early sepsis resuscitation in all septic patients. All five trials, like other PETAL studies, include a unique framework that encourages ancillary studies powered to address key basic science needs in disease pathogenesis and natural history.

ORCHID has affected clinical practice even before trial results are reported. The trial of hydroxychloroquine in hospitalized COVID-19 patients was halted in June 2020 after the data and safety monitoring board reported apparent lack of efficacy. Use of hydroxychloroquine to treat COVID-19 began dropping soon after the National Institutes of Health halted the trial.

“We went from completion of designing the study protocol to enrolling the first patient within 2 weeks,” said Dr. Hite, professor, endowed chair and director of medical intensive care at the University of Cincinnati College of Medicine. “Approximately 500 patients were enrolled in just 3 months between March and June—an unprecedented time frame. The novel approaches utilized to complete this timely and essential trial will have a lasting impact on all critical care trials that goes beyond its important clinical results regarding use of hydroxychloroquine for COVID-19.”

A second COVID-19 trial, ACTIV-3, has already enrolled more than 100 patients. One of five related trials in the Accelerating COVID-19 Therapeutic Interventions and Vaccines program (ACTIV-3) uses an adaptive two-stage phase 3 protocol to test monoclonal antibody treatments in hospitalized patients.

The first candidate Mab is LY-CoV555, identified in blood from a recovered COVID-19 patient. The Mab was isolated, synthesized, and developed by AbCellera Biologics and Eli Lilly.

VIOLET researchers examined the impact of early high-dose vitamin D in the prevention of ARDS, which proved not to improve 90-day mortality or nonfatal outcomes in patients at risk for ARDS. Although a negative trial for patient benefit, VIOLET provided abundant information that will improve design and implementation of future ARDS prevention trials, Dr. Hite said.

The CLOVERS trial compares aggressive vs less aggressive fluid administration and early vs late use of vasopressors. Once available, the final results will impact practice for early resuscitation for septic shock.

“This is an age-old question in emergency medicine and critical care,” Dr. Hite said.

CLOVERS was put on hold by most US hospitals early in the COVID-19 pandemic. The trial was on track with over 1,300 patients enrolled—more than half needed for study completion.

“It’s such an important study that the PETAL Network is quickly working to restart the trial at sites to be sure the trial gets finished,” Dr. Hite said. “Our session will present data that the trial design is working effectively and should address the vital clinical question comparing benefits and safety of fluids and vasopressors.”

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