Trial registration number
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NCT04338828 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04338828
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First author
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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N. Stuart Harris, MD, MFA
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Contact
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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nsharris@mgh.harvard.edu
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-04-08
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Recruitment status
Last imported at : Jan. 8, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Terminated
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
age ≥ 18 years old
presentation to the ed with respiratory symptoms likely caused by covid-19
patient displays at least one of the following
respiratory rate ≥ 24
new cough
new atypical chest pain
new dyspnea
oxygen saturation < 97% at rest
chest x-ray with new changes consistent with covid-related airspace disease
cleared for discharge home by attending physician
obtained covid testing (results not required at time of enrollment)
onset of symptoms ≤12 days prior to ed visit
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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- attending physician estimation (< 50% likelihood) of other more likely non-covid
etiology
- presence of tracheostomy
- requirement of oxygen therapy to maintain resting oxygen saturation of > 94%
- clinical contraindication to use of inhaled nitric oxide
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Massachusetts General Hospital
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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United States
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Mild disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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1: Mild disease at enrollment
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Total sample size
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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47
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Rates of return visits to the ED
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
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Phase 2
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 890, "treatment_name": "Nitric oxide gas", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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