PETAL Network: Prevention & Early Treatment of Acute Lung Injury

PETAL Network: Prevention & Early Treatment of Acute Lung Injury

Network Studies

Primary PETAL Studies

Reevaluation of Systemic Early Neuromuscular Blockade (ROSE)

This study was evaluating whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival. Half of the patients received a neuromuscular blocker for two days and in the other half the use of neuromuscular blockers will be discouraged.

Low Tidal Volume Universal Support: Feasibility of Recruitment for Interventional Trial (LOTUS FRUIT)

This was an observational study that collected data from sites to assess hospital mechanical ventilation practices. The purpose of this study was to (1) inform the design and plan for future interventional trials of low tidal volume ventilation in emergency departments and intensive care units and (2) determine the practicality of data collection for patients with acute respiratory failure in trials. Data was collected for a one-month period at all PETAL hospitals to determine the feasibility of performing a larger randomized controlled trial.

Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET)

This study looked at the effect of early administration of high-dose vitamin D₃ in reducing mortality in patients with low levels of Vitamin D who are at high risk for acute respiratory distress syndrome (ARDS). Patients were screened for vitamin D deficiency (levels less than 20ng/mL). Those patients meeting the screening threshold were be randomized into the trial. Half of the vitamin D deficient patients were given a high dose of vitamin D₃, and the other half were given a placebo (like a sugar pill).

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS)

The CLOVERS study compared two methods of increasing blood pressure in patients with dangerously low blood pressure due to a suspected infection. One method is to first provide intravenous fluids to the patient, and then use medicines to raise blood pressure; the other method is to use the blood pressure medicines first, and then use fluids.

Acetaminophen in Sepsis: Target Therapy to Enhance Recovery (ASTER)

Many patients hospitalized with sepsis develop organ failure, including acute lung injury (ARDS), kidney injury, and cardiovascular dysfunction. This study aimed to test whether acetaminophen (also known as Tylenol) can improve survival for patients with sepsis.

The ASTER trial originally studied both acetaminophen and Vitamin C. The Vitamin C arm of the trial was stopped on June 15th and a revised study protocol studying a higher dose of acetaminophen versus placebo was proposed by PETAL investigators and approved by NHLBI and the Institutional Review Board overseeing PETAL studies. Enrollment began in the revised trial on August 16, 2022.

PETAL-Sponsored COVID-19 Studies

Outcomes Related to COVID-19 Treated with Hydroxychloroquine among In-patients with Symptomatic Disease (ORCHID)

ORCHID was a blinded, multicenter, placebo-controlled randomized clinical trial of oral doses of Hydroxychloroquine as compared to a matching placebo to treat patients hospitalized with COVID-19 illness (by positive test or presumed positive based on protocol specified criteria).

PETAL Repository of Electronic Data COVID-19 Observational Study (RED CORAL)

RED CORAL identified acute and critically ill patients with COVID-19 and collected detailed data from their hospital stay. This data was shared with the WHO/ISARIC COVID registry and the scientific community to advance United States participation in studies of global epidemiology. The study aimed to increase the understanding of the clinical course of COVID-19.

Biology and Longitudinal Epidemiology of PETAL COVID-19 Observational Study (BLUE CORAL)

The BLUE CORAL study was an observational study that is collecting information to learn more about SARS-CoV-2, the virus that causes COVID-19, and how to better care for people who are sick from COVID-19. Information was collected from study participants’ medical records and by asking them questions during their hospital stay and the first month after they left the hospital.

Functional, Imaging, and Respiratory Evaluation in CORAL (FIRE CORAL)

FIRE CORAL is an ancillary study to BLUE CORAL that aims to describe post-hospital outcomes for patients previously hospitalized with COVID-19. This study looked at lung function, recovery trajectories, and biospecimens to better understand clinical and biologic factors associated with persistent impairment of the lungs.

COVID-19 Trials with PETAL Participation

ACTIV-3: Therapeutics for Inpatients with COVID-19 (TICO)

ACTIV-3 is a collaboration of INSIGHT and four other research networks. It was designed to evaluate the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection.

ACTIV-3b: Therapeutics for Severely Ill Inpatients with COVID-19 (TESICO)

ACTIV-3b TESICO is a collaboration of INSIGHT and four other research networks. It was designed to evaluate the safety and effectiveness of different drugs in treating acute respiratory failure related to COVID-19. The focus of this trial is on patients with critical respiratory failure and recruits many of its patients in ICU settings.

ACTIV-4a: A Multicenter, Adaptive, Randomized, Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19

ACTIV-4a is a multicenter clinical trial that tested if treatments that aim to prevent blood vessel injuries and blood clots improve recovery from patients hospitalized due to COVID-19.

ACTIV-4 Host Tissue: Targeting Host Tissue and the Renin-Angiotensin-Aldosterone System (RAAS) in hospitalized patients with COVID-19

ACTIV-4 Host Tissue aims to find effective strategies for patients hospitalized with COVID-19 by impacting the Renin-Angiotensin-Aldosterone System (RAAS). RAAS is the system in your body of hormones, proteins, enzymes and reactions that regulate blood pressure and has been directly implicated in the development of acute respiratory distress syndrome (ARDS).