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iNOPulse for COVID-19 (NO-COVER)

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ClinicalTrials.gov Identifier: NCT04398290
Recruitment Status : Withdrawn (IRB AND FDA REVIEWS DEFERRED)
First Posted : May 21, 2020
Last Update Posted : August 19, 2020
Sponsor:
Collaborator:
Bellerophon Therapeutics
Information provided by (Responsible Party):
Roger Alvarez, University of Miami

Tracking Information
First Submitted Date  ICMJE May 20, 2020
First Posted Date  ICMJE May 21, 2020
Last Update Posted Date August 19, 2020
Estimated Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2020)
  • Incidence of treatment emergent adverse events [ Time Frame: Up to 14 days ]
    As assessed per treating physician's discretion.
  • Incidence of adverse events [ Time Frame: Up to 6 hours ]
    Incidence of hypoxemia and hypotension as assessed per treating physician's discretion.
  • Incidence of methemoglobinemia [ Time Frame: Up to 14 days ]
    Incidence of increase to > 5% total methemoglobin as assessed by pulse oximetry.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2020)
  • Number of participants with progression of respiratory failure [ Time Frame: Up to 14 days ]
    Worsening respiratory status as defined by any one of the following: Implementation of High Flow Nasal Cannula (HFNC), non-rebreather mask, non-invasive ventilation, intubation and mechanical ventilation or need for intubation (in the event the patient is not intubated due to do not intubate (DNI) or do not resuscitate (DNR) status).
  • Time until resolution of hypoxemia [ Time Frame: Up to 14 days ]
    The number of days until hypoxemia is resolved as per treating physician assessment
  • Incidence of mortality [ Time Frame: Up to 28 days ]
    Incidence of death during hospitalization and after discharge up to 28 days
  • Duration of hospitalization [ Time Frame: Up to 28 days ]
    Number of days of hospitalization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE iNOPulse for COVID-19
Official Title  ICMJE Randomized Controlled Trial Of A Delivered Continuously By Nasal Cannula For The Treatment Of Patients With COVID-19 And Mild To Moderate Hypoxemia Requiring Supplemental Oxygen
Brief Summary This randomized, controlled trial will assess the efficacy and safety of pulsed iNO in subjects with COVID-19 who are hospitalized and require supplemental oxygen.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Hypoxemia
  • Hypoxemic Respiratory Failure
Intervention  ICMJE
  • Drug: Inhaled nitric oxide (iNO)
    iNO Pulse 250 mcg/kg ideal body weight (IBW)/hour
  • Drug: Nitrogen gas
    250 mcg/kg ideal body weight (IBW)/hour
  • Drug: Oxygen gas
    Supplemental oxygen administered via nasal cannula
Study Arms  ICMJE
  • Experimental: iNOpulse Treatment Group
    Participants in this group will receive iNO delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days.
    Interventions:
    • Drug: Inhaled nitric oxide (iNO)
    • Drug: Oxygen gas
  • Active Comparator: Placebo Group
    Participants in this group will receive nitrogen gas delivered continuously together with supplemental oxygen by nasal cannula during hospitalization for up to 28 days
    Interventions:
    • Drug: Nitrogen gas
    • Drug: Oxygen gas
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 17, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2020)
30
Estimated Study Completion Date  ICMJE July 15, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18 or above
  2. Proven COVID-19 viral infection. Non-confirmed highly suspicious suspects may be enrolled.
  3. Presence of radiographic findings compatible with pneumonia/pneumonitis.
  4. Patients requiring at least 3 L/m oxygen via nasal canula to maintain O2 above 92%.
  5. Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine).
  6. Willing and able to comply with treatment schedule and study procedures.

Exclusion Criteria:

  1. Patient with severe hypoxemia who are unable to maintain an oxygen saturation (SpO2) > 88% on a maximum supplemental oxygen of 6 L/m by nasal cannula and a non-rebreather facemask.
  2. Participating in any other clinical trial for COVID-19
  3. Pregnancy, or positive pregnancy test in a pre-dose examination.
  4. Open tracheostomy.
  5. Clinical contra-indication, as deemed by the PI or their designee.
  6. Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as intravenous lidocaine, or topical benzocaine or dapsone at screening.
  7. Known history or clinical evidence of heart failure or left ventricular dysfunction (LVEF < 45%).
  8. Significant hemoptysis
  9. Unable to provide informed consent (proxy consent is acceptable if available)
  10. Any of the following conditions at time of possible enrollment: Fulminant Liver Failure, Acute Coronary Syndrome , Renal Failure requiring dialysis, Bacteremia, Shock, Cardiac arrest, Cardiac arrhythmia requiring acute treatment, Delirium / Encephalopathy, Severe Disseminated Intravascular Coagulation, Gastrointestinal hemorrhage, Hypoglycemia, Pneumothorax, Rhabdomyolysis / Myositis, Seizures, or Acute Stroke
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04398290
Other Study ID Numbers  ICMJE 20200449
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Roger Alvarez, University of Miami
Study Sponsor  ICMJE Roger Alvarez
Collaborators  ICMJE Bellerophon Therapeutics
Investigators  ICMJE
Principal Investigator: Roger A Alvarez, D.O. University of Miami
PRS Account University of Miami
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP