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

COVID-19 Clinical Trial

Official title:

Use of High Dose Inhaled Nitric Oxide in Intubated Patients Admitted With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383002
• Other study ID #: 20-5449
• Status: Completed
• Phase: Phase 1
• Start date: September 2, 2020
• Est. completion date: June 11, 2021

Study information

• Verified date: May 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 11, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network, Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 PCR status at completion of treatment (day 7) from tracheal aspirate		7 days