Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT04383002
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04383002
Study Brief:
Protocol Section:
NCT04383002