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High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04383002
Recruitment Status : Active, not recruiting
First Posted : May 11, 2020
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE May 1, 2020
First Posted Date  ICMJE May 11, 2020
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE September 2, 2020
Actual Primary Completion Date May 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
COVID-19 PCR status at completion of treatment (day 3) from tracheal aspirate [ Time Frame: 3 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)
Official Title  ICMJE Use of High Dose Inhaled Nitric Oxide in Intubated Patients Admitted With COVID-19
Brief Summary Novel therapies are desperately needed for treatment of COVID-19 patients. At present, there are no proven interventions to prevent progression of the disease or to rapidly treat patients with COVID-19 related respiratory failure. Data on the original coronavirus -SARS pneumonia suggested that high dose (>160ppm) inhaled Nitric Oxide could have beneficial effects also on COVID-19, due to the genomic similarities between these two coronaviruses (1-3). This study will test whether high dose inhaled nitric oxide is safe and can reverse virus burden and respiratory failure in patients on mechanical ventilation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Drug: Nitric Oxide
iNO will be given at 160ppm for 6 hours, once a day, for 2 days
Study Arms  ICMJE
  • No Intervention: Standard of Care (control)
    Patients will receive standard of care therapy
  • Experimental: Inhaled Nitric Oxide
    Intervention: Drug: Nitric Oxide
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 12, 2021)
21
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
20
Estimated Study Completion Date  ICMJE June 11, 2021
Actual Primary Completion Date May 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Confirmed infection with COVID-19 positive RT-PCR tracheal aspirate prior to treatment
  2. Use of mechanical ventilation with or without ECMO
  3. Male or female ages > 18 years
  4. < 14 days from symptom initiation to study enrolment and < 7 days from intubation to study enrolment

Exclusion Criteria:

  1. Patients on other interventional clinical trials
  2. Subjects diagnosed with congestive or unstable heart disease including heart failure, left ventricular dysfunction (LVEF < 40 %) or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
  3. Subjects diagnosed with immunodeficiency
  4. Hematology: patients with clinically significant anemia e.g. Hemoglobin < 100 and thrombocytopenia e.g. Platelets < 75
  5. Subjects with clinically significant history of, or active bleeding including active pulmonary or gastrointestinal bleeding
  6. Hepatic Function: Patients with abnormal liver function defined as any two of the following ALT >3x ULN, AST >3x ULN, Total bilirubin < 1.5 X ULN
  7. Patient receiving drugs that have a contraindication with NO e.g. use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine or dapsone at screening as relevant to the proposed study population
  8. Pregnancy
  9. Subjects with a known hypersensitivity to methylene blue, subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency
  10. Known or suspected thalassemia, sickle cell disease, or other conditions associated with poor oxygen carrying capacity
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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04383002
Other Study ID Numbers  ICMJE 20-5449
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marcelo Cypel, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date May 2021

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