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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT04383002
Collaborator
(none)
21
1
2
9.3
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nitric Oxide
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of High Dose Inhaled Nitric Oxide in Intubated Patients Admitted With COVID-19
Actual Study Start Date :
Sep 2, 2020
Actual Primary Completion Date :
May 11, 2021
Actual Study Completion Date :
Jun 11, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard of Care (control)

Patients will receive standard of care therapy

Experimental: Inhaled Nitric Oxide

Drug: Nitric Oxide
iNO will be given at 160ppm for 6 hours, once a day, for 2 days

Outcome Measures

Primary Outcome Measures

  1. COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Health Network, Toronto General Hospital Toronto Ontario Canada M5G 2C4

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Marcelo Cypel, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT04383002
Other Study ID Numbers:
  • 20-5449
First Posted:
May 11, 2020
Last Update Posted:
Apr 11, 2022
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 11, 2022