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Primary study

  • ROSE: Reevaluation Of Systemic Early neuromuscular blockade

    Status:
    Stopped
    Period:
    January 2016 to December 2018
    NCT ID:
    NCT02509078

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

    Trial Summary:

    • Study Design: This is a multi-center, prospective, 2-arm, unblinded, randomized clinical trial of two management strategies of neuromuscular blockade (also called skeletal muscle relaxant and muscle relaxant).
    • Purpose: To assess the efficacy and safety of early neuromuscular blockade in reducing mortality and morbidity in patients with moderate-severe ARDS in comparison to a control group with no routine early neuromuscular blockade.
    • Sample Size: This trial will enroll approximately 1400 subjects from PETAL network hospital ICUs.

  • VIOLET: Vitamin D to Improve Outcomes by Leveraging Early Treatment

    Status:
    Completed
    Period:
    April 2017 to November 2019
    NCT ID:
    NCT03096314

    Purpose: This study will look 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 will be screened for vitamin D deficiency (levels less than 20 ng/mL). Those patients meeting the screening threshold will be randomized into the trial. Half of the vitamin-D deficient patients will be given a high-dose of vitamin D3 and the other half will be given a placebo (like a sugar pill).

    Trial Summary:

    • Study Design: Randomized, double-blinded, placebo-controlled, phase III trial of early vitamin D3 in vitamin D deficient patients at high risk for ARDS and mortality.
    • Purpose: To assess the efficacy and safety of early administration of vitamin D3 (cholecalciferol) in reducing mortality and morbidity for vitamin D deficient patients at high risk for ARDS and mortality.
    • Sample Size: The study will randomize up to 3,000 patients from PETAL network hospital emergency departments, ICUs, and general floors.

  • CLOVERS: Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

    Status:
    Stopped
    Period:
    March 2018 to February 2022
    NCT ID:
    NCT03434028

    Purpose: The CLOVERS study compares two methods of increasing blood pressure in patients with dangerously low blood pressure due to a suspected infection. One method is the first provide intravenous fluids to the patient, and then use drugs such as adrenalin (called vasopressors); the other method is to use the drugs first, and then use fluids.

    Trial summary:

    • Study design: this is a multi-center, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension (dangerously low blood pressure from a suspected infection).
    • Purpose: to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension.
    • Sample size: this trial will enroll up to 2,230 subjects from PETAL network emergency rooms.

    Update January 21, 2023

    Findings from a randomized, non-blinded, phase 3 clinical trial supported by the National Institutes of Health found no significant difference in 90-day mortality rates, nor safety concerns, after providing patients with one of two common treatment strategies for sepsis. The findings were published in the New England Journal of Medicine (No differences found between liberal or restrictive fluid treatment strategies for septic-inducted hypotension) and were simultaneously presented at the 2023 Critical Care Congress.

    The Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) trial is a randomized clinical trial conducted by the Prevention and Early Treatment of Acute Lung Injury external link (PETAL) network and funded by the National Heart, Lung, and Blood Institute (NHLBI). Enrollment in the trial ended in February 2022 due to a lack of significant difference observed between the two 24-hour strategies.

    The trial, which included 1,563 patients from 60 medical centers, also found no significant differences in 90-day survival rates or other measures of recovery, such as length of hospital stay, among adults assigned to a restrictive or liberal fluid-management treatment strategy for a sudden drop in blood pressure due to sepsis.

  • RED CORAL: PETAL Repository of Electronic Data COVID-19 Observational Study

    Status:
    Completed
    Period:
    March 2020 to June 2020
    NCT ID:
    N/A

    Rational

    The epidemiology of patients hospitalized with severe COVID-19 has not been well defined, especially in the American context. There are significant knowledge gaps regarding demographics, clinical characteristics, trajectory of disease, timing of recovery, predictors of organ failure and death, resource utilization, and post-hospital outcomes. In response, the purpose of the RED CORAL study is to inform epidemiology and resource utilization through data collection and creation of a data repository.

    The Prevention and Early Treatment of Acute Lung Injury (PETAL) Network is a consortium of academic and affiliated hospitals across the United States, funded by the NHLBI to conduct clinical trials in patients with or at risk for critical illness, including ARDS. Our Network’s goal is to improve outcomes of patients with acute and critical illness through research.

    Study Aim

    We will identify acute and critically ill patients with COVID-19 and collect detailed data from their hospital stay. We will contribute data to the WHO/ ISARIC COVID registry and to the scientific community in order to advance United States participation in studies of global epidemiology. We will use the data to increase understanding of the clinical course of COVID-19.

    Study Population

    RED CORAL will include adult patients with confirmed COVID-19 hospitalized at participating sites who have available clinical data. The study period will include patients who present for admission to study hospitals between March 1st and April 1st, 2020.

  • ORCHID: Outcomes Related to COVID-19 Treated with Hydroxychloroquine among In-patients with Symptomatic Disease

    Status:
    Stopped
    Period:
    April 2020 to June 2020
    NCT ID:
    NCT04332991

    Effective therapies for COVID-19 are urgently needed. The PETAL Network is responding to the COVID-19 crisis and redirecting effort to develop and deploy COVID-19 trials. The first was the ORCHID Trial. Hydroxychloroquine is an antimicrobial agent with immunomodulatory and antiviral properties that has demonstrated in vitro activity against SARS-CoV-2, the virus that causes COVID-19. Preliminary reports suggested potential efficacy in small human studies. Clinical trial data was needed to determine whether hydroxychloroquine is effective in treating COVID-19.

    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 specific criteria).

    This trial was launched in the first week of April and enrolled 479 patients in less than 3 months. It was stopped mid-June after showing no evidence of benefit or harm.

    UPDATE JUNE 20, 2020

    Major US Trial Closes Showing No Benefit for Hydroxychloroquine in COVID-19

    June 20, 2020

    The Outcomes Related to COVID-19 Treated with Hydroxychloroquine among In-patients with Symptomatic Disease (ORCHID) trial stopped enrolling new patients based on the fourth scheduled interim analysis showing no evidence of benefit or harm.

    The ORCHID trial enrolled 479 adult patients hospitalized with COVID-19 in 11 weeks at 34 hospitals in the United States. It was a multicenter, blinded, placebo-controlled randomized trial, which is the most rigorous study design to evaluate the effects of a medication. In addition to usual medical care for COVID-19, patients in the trial were treated with either 5 days of hydroxychloroquine or a placebo pill that did not have medication in it. Patients, treating clinicians, and researchers were all “blinded,” meaning that they did not know whether a given patient was receiving hydroxychloroquine or placebo.

    Preliminary results suggested that hydroxychloroquine was neither beneficial nor harmful for patients with COVID-19. A full analysis of trial results is ongoing and will be submitted for peer review as soon as possible.

    “We rapidly conducted a high-quality study to understand if hydroxychloroquine helps patients hospitalized with COVID-19,” said Wesley H. Self, MD, an emergency physician at Vanderbilt University Medical Center and lead investigator for ORCHID. “These results provide a high level of certainty that hydroxychloroquine is not a useful treatment for adults admitted to the hospital with COVID-19.”

    Samuel M. Brown, MD, a critical care physician at Intermountain Medical Center who helped lead the trial said, “It was critically important to understand the effects of hydroxychloroquine when used to treat COVID-19. We express our sincere gratitude to the patients, families, and research staff who participated in this important study.”

    The ORCHID trial was funded by the National Heart, Lung, and Blood Institute (NHLBI), which is part of the National Institutes of Health (NIH), and conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network, a group of researchers at approximately fifty hospitals focused on answering important questions for patients with severe illness evaluated in an emergency department or hospital.

  • BLUE CORAL: Biology and Longitudinal Epidemiology of PETAL COVID-19 Observational Study

    Status:
    Completed
    Period:
    June 2020 to July 2021

    What is BLUE CORAL?

    The BLUE CORAL study is a research 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.

    Who can be in this study?

    Adults admitted to the hospital within 14 days of a test positive for SARS-CoV-2, the virus that causes COVID-19 and have symptoms of the virus (fever, cough, or trouble breathing) may be eligible for the study. Only hospitals that are part of the PETAL Network can enroll subjects.

    What Happens in this study?

    • Information will be collected from study participants’ medical records and by asking them questions during the time they are in the hospital and in the first month after they leave the hospital
    • Some additional blood tests may be performed
    • Some participants may be asked for permission to collect additional blood for future studies to learn more about COVID-19
    • Some participants may be contacted after they leave the hospital to see how they and doing and feeling

    Who is paying for this study?

    The National Heart, Lung and Blood Institute (NHLBI), which is part of the U.S. government, is paying for this research.

    Trial Summary:

    Purpose:

    BLUE CORAL is a detailed prospective cohort study of patients hospitalized with acute SARS-CoV2 infection at PETAL Network hospitals. The primary objective of BLUE CORAL is to describe the clinical characteristics, treatments, biology and outcomes of 1500 hospitalized patients with Covid-19. In addition to all hospital data collected in RED CORAL, BLUE CORAL adds (1) in-hospital surveys detailing premorbid function, (2) biospecimen collection, and (3) centralized post-hospital telephone follow-up at 1, 3 and 6 months after hospital discharge.

    Study Design:

    Observational study of hospitalized patients with COVID-19

    Primary Objectives

    Describe the clinical characteristics, treatments, biology, and outcomes of hospitalized patients with COVID-19

    Secondary Objectives

    • Identify clinical and biologic risk factors and create prediction models for COVID-19 outcomes, including acute respiratory failure, prolonged mechanical ventilation, cardiomyopathy, and death
    • Create a deidentified repository of clinical, imaging, and biologic data and of biospecimens for rapid sharing with the scientific community

    Study Size:

    This study will enroll up to 1500 people hospitalized due to COVID-19 infection.

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

    Status:
    Active
    Period:
    August 2020
    NCT ID:
    NCT04501978

    What is ACTIV-3?

    In response to the global COVID-19 pandemic, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private initiative was organized by NIH and the Foundation for the NIH (FNIH). ACTIV developed an international strategy for an integrated research response to COVID-19.

    ACTIV-3 is a collaboration of INSIGHT and four other research networks: AIDS Clinical Trials Group (ACTG), Cardiothoracic Surgical Trials Network (CTSN), Prevention and Early Treatment of Acute Lung Injury (PETAL) and the US Department of Veterans Affairs (VA).

    ACTIV-3 is designed to evaluate the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection.

    Who can be in this study?

    COVID-positive adults admitted to the hospital who have had symptoms (fever, cough, or trouble breathing, etc) for ≤ 12 days may be eligible for this study. Only hospitals that are part of the [INSIGHT Network] (https://insight.ccbr.umn.edu/index.php) and registered for TICO recruitment can enroll subjects.

    What Happens in this study?

    • Information will be collected from study participants’ medical records and by asking them questions during the time they are in the hospital.
    • Participants will receive an infusion of the study drug or be treated as usual by their doctors. Assignment is determined by random chance, like the flip of a coin. Neither participants nor their doctors will know what assignment they receive.
    • Some additional blood tests will be performed 3, 5, 28, and 90 days after enrollment.
    • Participants may be asked for permission to collect additional blood for future studies to learn more about COVID-19.
    • Participants will be contacted after they leave the hospital to see how they and doing and feeling.

    Who is paying for this study?

    The National Institutes of Health (NIH), which is part of the U.S. government, is paying for this research.

    Trial Summary:

    Purpose:

    The study will evaluate the safety and efficacy of multiple investigational agents intended to enhance the host immune response to SARS-CoV-2 infection, or directly enhance viral control, in order to limit disease progression. Using a master protocol, successive trials within this protocol will be adaptive, randomized, and initially placebo-controlled. All participants will receive standard of care (SOC) treatment. If an investigational agent shows superiority over placebo + SOC as initially defined, SOC for future investigational treatment evaluations will be modified accordingly. The initial investigational agents will be neutralizing monoclonal antibodies.

    Study Design:

    Phase III multicenter, adaptive, randomized, blinded and placebo-controlled

    Primary Objectives

    Time from randomization to sustained recovery at day 90.

    Secondary Objectives

    • Organ dysfunction that may be associated with progression of COVID-19
    • Extra-pulmonary manifestations of COVID-19

    Study Size:

    This study will enroll up to 1,000 people hospitalized due to COVID-19 infection.

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

    Status:
    Active
    Period:
    September 2020
    NCT ID:
    NCT04505774

    What is ACTIV-4a?

    Many patients hospitalized with COVID-19 develop blood clots and signs of coagulation in multiple organs in autopsy findings. These signs of increase coagulation correlate with worse organ failure and mortality. The ACTIV-4a is a multi-center clinical trial looking at agents that decreases coagulation of the blood in patients hospitalized for COVID-19.

    Who can be in this study?

    Adults (age 18 and older) admitted to the hospital with symptomatic COVID-19 infection within 3 days of infection or presentation.

    What Happens in this study?

    • A random half of the patients in the study will receive an agent that decreased clots blood coagulation while the other half will be treated as usual by their doctors. This will continue for 14 days or until the patient leaves the hospital, whichever comes first
    • Information will be collected from study participants’ medical records and by phone calls after they leave the hospital at about 3 months
    • Some additional blood tests may be performed

    Who is paying for this study?

    The National Institutes of Health (NIH), which is part of the U.S. government, is paying for this research.

    Trial Summary:

    Purpose:

    ACTIV-4A aims to determine the effectiveness of antithrombotic strategies for prevention of adverse outcomes and organ failure in COVID-19 positive inpatients. Different anti-thrombotic agents will be evaluated including anticoagulation like heparin or anti-platelet agents like P2Y12 inhibitors.

    Study Design:

    ACTIV-4A is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic strategies for prevention of adverse outcomes in COVID-19 positive inpatients.

    Primary Objectives

    To determine the most effective antithrombotic strategy for increasing the number of days free of organ support and reducing death.

    Secondary Objectives

    • To determine the most effective antithrombotic strategy on the composite endpoint of death, deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), ischemic stroke, or other systemic arterial thrombosis (AT).
    • To assess the safety of antithrombotic strategies through the endpoint of major bleeding as defined by the International Society on Thrombosis and Hemostasis.
    • To compare the effect of antithrombotic strategies on the endpoint of all-cause mortality in the study population.

    Study Size:

    Sample size will depend on the agent being tested, event rate and probability of benefit of the agent being investigated.

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

    Status:
    Active
    Period:
    April 2021
    NCT ID:
    NCT04843761

    What is ACTIV-3b/TESICO?

    In response to the global COVID-19 pandemic, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private initiative was organized by NIH and the Foundation for the NIH (FNIH). ACTIV developed an international strategy for an integrated research response to COVID-19.

    ACTIV-3b/TESICO is a collaboration of INSIGHT and four other research networks: AIDS Clinical Trials Group (ACTG), Cardiothoracic Surgical Trials Network (CTSN), Prevention and Early Treatment of Acute Lung Injury (PETAL) and the US Department of Veterans Affairs (VA).

    ACTIV-3b/TESICO is 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.

    Who can be in this study?

    Adults admitted to the hospital with a positive COVID-19 test in the prior 14 days and current respiratory failure due to COVID-19 may be eligible for this study. Only hospitals that are part of the INSIGHT Network and registered for TICO recruitment can enroll subjects.

    What Happens in this study?

    • Information will be collected from study participants’ medical records and by asking them questions during the time they are in the hospital.
    • Participants will receive an infusion of the study drug(s) or be treated as usual by doctors. Assignment is determined by random chance, like the flip of a coin. Neither participants nor their doctors will know what assignment they receive
    • Some additional blood tests will be performed on enrollment and at days 3 & 5 if participants are still in the hospital
    • Participants may be asked for permission to collect additional blood for future studies to learn more about COVID-19
    • Participants will be contacted after they leave the hospital to see how they and doing and feeling

    Who is paying for this study?

    The National Institutes of Health (NIH), which is part of the U.S. government, is paying for this research.

    Trial Summary:

    Purpose:

    The study will evaluate the safety and efficacy of investigational agents aimed at improving outcomes of patients with acute respiratory failure related to COVID-19. Using a master protocol, successive trials within this protocol will be adaptive, randomized, and initially placebo-controlled. All participants will receive standard of care (SOC) treatment. If an investigational agent shows superiority over placebo + SOC as initially defined, SOC for future investigational treatment evaluations will be modified accordingly. The first investigational agents studied will be aviptadil (generic name for the synthetic version of Vasoactive Intestinal Peptide [VIP]) and remdesivir in a 2x2 factorial design.

    Study Design:

    Phase III multicenter, adaptive, randomized, blinded and placebo-controlled

    Primary Objectives

    Time from randomization to sustained recovery at day 90.

    Secondary Objectives

    • Organ dysfunction that may be associated with progression of COVID-19
    • Extra-pulmonary manifestations of COVID-19

    Study Size:

    This study will enroll approximately 640 people for each investigational agent/placebo.

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

    Status:
    Active
    Period:
    June 2021
    NCT ID:
    NCT04924660

    What is ACTIV-4 Host Tissue?

    In response to the global COVID-19 pandemic, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private initiative was organized by NIH and the Foundation for the NIH (FNIH). ACTIV developed an international strategy for an integrated research response to COVID-19 by evaluating and prioritizing promising candidates for COVID-19 treatment.

    ACTIV-4 Host Tissue aims to find effective strategies for patients hospitalized with COVID-19 by impacting the Renin-Angiotensin-Aldosterone System (RAAS), which has been directly implicated in the development of acute respiratory distress syndrome (ARDS).

    Who can be in this study?

    COVID-positive adults admitted to the hospital requiring supplemental oxygen may be eligible for this study. Only hospitals that are registered for recruitment can enroll subjects.

    What Happens in this study?

    • Information will be collected from study participants’ medical records and by asking them questions during the time they are in the hospital.
    • Participants will either receive a study medication or be treated as usual by their doctors. Assignment is determined by random chance, like the flip of a coin. Neither participants nor their doctors will know what assignment they receive.
    • Some additional blood tests may be performed
    • Participants will be contacted after they leave the hospital to see how they and doing and feeling.

    Who is paying for this study?

    The National Heart, Lung and Blood Institute (NHLBI), which is part of the U.S. government, is paying for this research.

    Trial Summary:

    Purpose:

    The study will evaluate the safety and efficacy of multiple investigational agents intended to enhance the host immune response to SARS-CoV-2 infection, or directly enhance viral control, in order to limit disease progression. Using a master protocol, successive trials within this protocol will be adaptive, randomized, and initially placebo controlled. All participants will receive standard of care (SOC) treatment. If an investigational agent shows superiority over placebo + SOC as initially defined, SOC for future investigational treatment evaluations will be modified accordingly. The initial investigational agents will be neutralizing monoclonal antibodies.

    Study Design:

    Multicenter, randomized, blinded, and placebo-controlled master protocol

    Primary Objectives

    To hasten recovery and prevent progression of critical illness in patients. We will assess this by looking at days without supplemental oxygen at 28 days after receiving study treatment.

    Secondary Outcome Measures

    • Organ dysfunction that may be associated with progression of COVID-19
    • Mortality

    Study Size:

    This study will enroll 600 patients per treatment arm (divided between placebo and active agent).

  • ASTER: Acetaminophen in Sepsis: Targeted Therapy to Enhance Recovery

    Status:
    Active
    Period:
    October 2021

    Revisions to the ASTER Study

    On June 15, 2022, the study was paused due to publication of the a the results of the Lessening Organ dysfunction with Vitamin C trial (LOVIT) and the simultaneous publication of a systematic review of all relevant trials of Vitamin C before it. Taken together, these two publications demonstrated that intravenous Vitamin C at the dose used in ASTER was not effective for patients with sepsis. Accordingly, the Vitamin C arm of the trial was stopped on June 15th and a revised study protocol studying acetaminophen versus placebo was proposed by PETAL investigators and approved by the NHLBI and the Institutional Review Board overseeing PETAL studies. Enrollment began in the revised trial on August 16, 2022. Publication of the Vitamin C results from the ASTER trial will follow completion of data collection and analysis in the Fall of 2022.

    What is ASTER?

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

    Who can be in this study?

    Adults (age 18 and older) admitted to the ICU with sepsis with hypotension or respiratory failure may be eligible for this study.

    What Happens in this study?

    • Participants will be randomly assigned to receive Tylenol or usual care.
    • Information will be collected from study participants’ medical records and by phone calls after they leave the hospital at about 3 months
    • Some additional blood tests may be performed

    Who is paying for this study?

    The National Heart, Lung and Blood Institute (NHLBI), which is part of the U.S. government, is paying for this research.

    Trial Summary:

    Purpose:

    To assess the efficacy of Acetaminophen in comparison to placebo for 120 hours in patients with sepsis who have evidence of either hemodynamic or respiratory organ failure.

    Study Design:

    ASTER is a randomized placebo-controlled double-blinded interventional trial of intravenous acetaminophen for patients with sepsis-induced hypotension or respiratory failure.

    Primary Objectives

    To determine if acetaminophen can increase number of days alive and free of assisted ventilation, vasopressors, or new renal replacement therapy over the first 28 days.

    Secondary Objectives

    • To determine ventilator, vasopressor, new renal replacement and hospital “free days”
    • To determine mortality, duration of ICU stay, development of respiratory failure, and blood tests over study period

    Study Size:

    This study will enroll approximately 450 patients across 2 treatment assignments.

Ancillary study

  • PRIMROSE: Effect of randomization to neuromuscular blockade on physical functional impairment and recovery in ARDS

    Status:
    Completed
    Period:
    June 2016 to May 2020
    NCT ID:
    NCT03038906

    Multi-center prospective cohort study using stage-appropriate multi-modal assessments of neuromuscular function to determine the effect of randomization to neuromuscular blockers (NMB) in the ROSE trial. The study will assess effect of NMB on the early development of neuromyopathy; on muscle function and strength at hospital discharge; and on physical recovery and healthcare utilization at 6 and 12 months after the development of severe ARDS.

  • RED ROSE (Reconciling Expected vs Delivered Tidal Volumes in ROSE with Patient-ventilator Dyssynchrony)

    Status:
    Stopped
    Period:
    December 2016 to April 2018

    Multi-center prospective observational study ancillary to the PETAL Network ROSE trial. The purpose of this study is to evaluate a proposed mechanism of benefit for neuromuscular blockers in the treatment of ARDS: occult high-VT breaths during low tidal volume ventilation.

  • Provider perceptions of neuromuscular blockade in ARDS (PETE ROSE)

    Status:
    Stopped
    Period:
    March 2017 to April 2018

    Observational study to understand bedside provider perceptions of neuromuscular blocker use in ARDS using interview tools. Interviews will be conducted with physicians, nurses, clinical pharmacists, and respiratory therapists providing direct care to patients in the intervention arm of ROSE, as well as physicians who have declined enrollment of their patients into the ROSE trial.

  • ROSE-Transthoracic Ultrasound Assessment of the Diaphragm (ROSETTA)

    Status:
    Pending
    Period:
    June 2017 to April 2021

    An observational trial involving a subset of subjects from the ROSE neuromuscular blocker trial. The study involves diaphramatic ultrasound on mechanically ventilated ROSE subjects to determine whether the rate and magnitude of decreases in diaphragm thickness are greater in patients receiving neuromuscular blocking agents.

  • Re-Evaluation of Systemic Early Neuromuscular Blockade and TransThoracic Ultrasound Assessment of the Diaphragm (ROSETTA)

    Status:
    Stopped
    Period:
    April 2021

    Diaphragm thickness will be measured using ultrasound in a subset of ROSE patients to determine whether the rate and magnitude of decreases in diaphragm thickness are greater in patients receiving neuromuscular blocking agents as compared to the control group.

  • FIRE CORAL: Functional, Imaging, and Respiratory Evaluation in CORAL

    Status:
    Active
    Period:
    June 2021

    What is 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 looks at lung function, recovery trajectories, and biospecimens to better understand clinical and biologic factors associated with persistent impairment of the lungs.

    Who can be in this study?

    Adults who were enrolled in BLUE CORAL and participated in the 1-month post-hospitalization telephone assessment may be eligible for this study. Only hospitals that are part of the PETAL Network and participating in FIRE CORAL can enroll subjects.

    What happens in this study?

    • Participants will take part in a variety of assessments. These include , questionnaires, breathing tests, walking and strength tests , a chest CT scan andblood collection.
    • Some participants may be asked to return for a second visit 3 months after the first to track their recovery.

    Who is paying for this study?

    The National Heart, Lung and Blood Institute (NHLBI), which is part of the U.S. government, is paying for this research.

    Trial Summary:

    Purpose:

    FIRE CORAL is an ancillary study to BLUE CORAL enrolling a subset of patients for long-term follow-up. This study aims to collect objective in-person clinical assessments of patients after hospital discharge in order to describe recovery after COVID-19. The PETAL network aims to address key information gaps and contribute foundational knowledge to the epidemiology and biology of COVID-19.

    Study Design:

    Observational study

    Primary Objectives

    Describe the clinical characteristics, treatments, biology, and outcomes of hospitalized patients with COVID-19

    Secondary Objectives

    • To describe the prevalence of abnormalities of pulmonary function, chest imaging, and functional status in patients hospitalized with COVID-19 3 months after discharge
    • To determine trajectory of recovery of pulmonary function and functional status between 3 and 6 months after COVID-19
    • To identify clinical and biologic factors associated with persistent impairment of pulmonary function, chest imagine, and functional status after hospitalization with COVID-19
    • To determine the independent association between patient-reported outcomes of impaired recovery with objective measures of pulmonary function and persistent inflammation
    • To create a repository of biospecimens that permits longitudinal analysis of biomarkers spanning hospitalization to posthospital discharge

    Study Size:

    This study will enroll approximately 80 people previously hospitalized due to COVID-19 infection.