About the network
The Clinical Trials Network for the Prevention and Early Treatment of Acute Lung Injury (PETAL Network) is a network of 12 Clinical Centers (CC) and 1 Clinical Coordinating Center (CCC) funded by the National Heart, Lung, and Blood Institute (NHLBI) to develop and conduct randomized controlled clinical trials to prevent or treat, and/or improve the outcome of patients who have, or who are at risk for, Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS).
History of the network
In August 2013, the National Heart, Lung, and Blood Institute (NHLBI) and National Institutes of Health (NIH) requested applications for a network that would “develop and conduct randomized controlled clinical trials to prevent, treat, and/or improve the outcomes of adult patients with or at risk for … ARDS.” The PETAL Network’s goals and guiding principles included: (1) conduct 3-5 phase III clinical trials of prevention or early treatment of patients with or at risk for ARDS. The goal was to enroll approximately 2640 over 5.5 years; (2) have investigator-initiated trials; (3) establish a central Institutional Review Board (IRB); (4) collect and research high quality biospecimens for molecular definitions of illness, recovery, and susceptibility; and (5) communicate with other critical care clinical research groups worldwide. The network had 12 clinical centers with approximately 50 hospitals across the United States.
Throughout the network’s nine years, five (ROSE, VIOLET, CLOVERS, ORCHID, and ASTER) randomized controlled trials were conducted with a total enrollment of 5015 patients, which almost doubles the projected total. In addition to these RCTs, the LOTUS FRUIT survey was conducted as well as the COVID-19 observational studies under the CORAL (RED CORAL, BLUE CORAL, FIRE CORAL) umbrella. PETAL Network sites also participated in several Operation Warp Speed trials to accelerate the development of COVID-19 therapeutic interventions: ACTIV-3, ACTIV-3b TESICO, ACTIV-4a, and ACTIV-4 Host Tissue.
On December 31, 2023, the PETAL Network grant came to a close. Several hospitals will continue researching therapies for ARDS through participation in the National Institute of Allergy and Infectious Diseases (NIAID)-funded STRIVE Network, NHLBI-funded ARDS, Pneumonia, Sepsis Network (APS Consortium), and BARDA-funded ARDS clinical trials network.
The clinical trial data and remaining biospecimens for all but the most recent PETAL Network trial (ASTER) are available to the public through BioLINCC and the ASTER data and specimens will be available in early 2024.