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

    Status:
    Active
    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.

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:
    Active
    Period:
    March 2018
    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.
  • 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

    Status:
    Active
    Period:
    June 2020

Ancillary study

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

    Status:
    Active
    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.

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

    Status:
    Pending
    Period:
    May 2017

    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.

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

    Status:
    Pending
    Period:
    June 2017

    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.