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

NCT ID: NCT04383002

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-02
• Study Completion Date: 2021-06-11

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care (control)

Patients will receive standard of care therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Inhaled Nitric Oxide

Group Type: EXPERIMENTAL

Nitric Oxide

Intervention Type: DRUG

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

Interventions

Nitric Oxide

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcelo Cypel, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

20-5449

Identifier Type: -

Identifier Source: org_study_id