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ARrest RESpiraTory Failure From PNEUMONIA (ARREST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193878
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University

Brief Summary:
This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.

Condition or disease Intervention/treatment Phase
Pneumonia Hypoxemia Acute Respiratory Failure COVID-19 Drug: Inhaled budesonide and formoterol Drug: Inhaled placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: ARrest RESpiraTory Failure From PNEUMONIA (ARREST PNEUMONIA)
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
4 ml aerosolized 0.9% saline every 12 hours x 14 doses
Drug: Inhaled placebo
aerosolized saline (4 ml of 0.9% saline) twice daily for up to 7 days
Other Name: aerosolized 0.9% saline

Active Comparator: Intervention
aerosolized formoterol (20 mcg/2 ml) and budesonide (1.0 mg/2 ml) every 12 hours x 14 doses
Drug: Inhaled budesonide and formoterol
aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 7 days
Other Name: Pulmicort Respules (budesonide) and Perforomist (formoterol)




Primary Outcome Measures :
  1. Acute respiratory failure (ARF) [ Time Frame: within 10 days of randomization ]
    High flow nasal cannula (HFNC) and/or Noninvasive ventilation (NIV) use for greater than 36 hours OR Invasive mechanical ventilation for greater than 36 hours OR Death in a patient placed on respiratory support (HFNC, NIV, ventilator) who dies before 36 hours


Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: within 60 days of randomization ]
  2. Duration of need for supplemental oxygen [ Time Frame: within 60 days of randomization ]
  3. Proportion of patients intubated for respiratory failure [ Time Frame: Within 10 days of randomization ]
  4. World Health Organization (WHO) ordinal scale [ Time Frame: Within 10 days of randomization ]
    The minimum value is death and the maximum is "not hospitalized, no limitations on activities". Lower values are worse.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe Pneumonia defined as hospitalization for acute (< 7 days) onset of symptoms (cough, sputum production, or dyspnea) and radiographic evidence of pneumonia by chest radiograph or CT scan and evidence of systemic inflammation (temperature < 35oC or > 38oC or WBC < 4000 or > 11,000 or procalcitonin > 0.5 mcg/L),

or

  • Confirmed or high-clinical suspicion (defined by fever > 100.4, and either cough or shortness of breath, and absence of alternative diagnosis) for COVID-19 infection

and

  • Hypoxemia defined as new requirement for supplemental oxygen with SpO2 < 90% on room air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or NIV (regardless of SpO2) at enrollment.

Exclusion Criteria:

  • Inability to obtain consent within 12 hours of meeting entry criteria
  • Intubation (or impending intubation) prior to enrollment (This does not include those patients receiving High flow nasal cannula (HFNC) oxygen or Noninvasive ventilation (NIV) prior to enrollment)
  • A condition requiring inhaled corticosteroids or beta-agonists, or chronic systemic steroid therapy equivalent to a dose >10 mg prednisone (this does not include patients receiving inhaled beta-agonists in the Emergency Department without an established indication if treating clinician is willing to discontinue subsequent treatments)
  • Do Not Intubate order but does not include a "Do Not Resuscitate" order
  • Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome
  • Not anticipated to survive > 48 hours or not expected to require > 48 hours of hospitalization
  • Contraindication or known allergy to inhaled corticosteroids or beta-agonists
  • Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular tachycardia within last 4 hours will be potentially eligible for enrollment after the condition has resolved
  • Patients with K+ < 3.0 will be potentially eligible for enrollment after the condition has resolved
  • Pregnancy
  • Incarcerated individual
  • Physician refusal of consent to protocol
  • Patient/surrogate refusal of consent to protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193878


Contacts
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Contact: Joe Levitt, MD 650-723-6381 jlevitt@stanford.edu
Contact: Emir Festic, MD Festic.Emir@mayo.edu

Locations
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United States, Arizona
Mayo Clinic - Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Rodrigo Cartin-Ceba, MD       cartinceba.rodrigo@mayo.edu   
Principal Investigator: Rodrigo Cartin-Ceba, MD         
University of Arizona Not yet recruiting
Tucson, Arizona, United States, 85724
Contact: Christian Bime, MD       cbime@deptofmed.arizona.edu   
Principal Investigator: Christian Bime, MD         
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Joe Levitt, MD    650-723-6381    jlevitt@stanford.edu   
Principal Investigator: Joe Levitt, MD         
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32608
Contact: Marie-Carmelle Elie, MD       elie@ufl.edu   
Principal Investigator: Marie-Carmelle Elie, MD         
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Emir Festic, MD       Festic.Emir@mayo.edu   
Principal Investigator: Emir Festic, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: William Checkley, MD, PhD       wcheckl1@jhmi.edu   
Principal Investigator: William Checkley, MD, PhD         
United States, Minnesota
Mayo Clinic - Rochester Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Rahul Kashyap, MBBS       Kashyap.Rahul@mayo.edu   
Principal Investigator: Ognjen Gajic, MD         
Principal Investigator: Rahul Kashyap, MBBS         
United States, New York
New York University - Langone Health Not yet recruiting
New York, New York, United States, 10016
Contact: David Kaufman, MD       David.A.Kaufman@nyumc.org   
Principal Investigator: David Kaufman, MD         
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Ian Welsby, MD       ian.welsby@duke.edu   
Principal Investigator: Ian Welsby, MD         
United States, Pennsylvania
Temple University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Nina Gentile, MD       ngentile@temple.edu   
Principal Investigator: Nina Gentile, MD         
Sponsors and Collaborators
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Joe Levitt, MD Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04193878    
Other Study ID Numbers: 53599
1UG3HL141722-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Respiratory Insufficiency
Hypoxia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Budesonide
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action