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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT04405102
Eligibility Criteria:
Inclusion criteria
* Confirmed COVID-19 (positive polymerase chain reaction (PCR) for COVID-19 from any specimen)
* Patients older than 18 years old and younger than 85 years old.
* BMI higher than 20 but lower than 40
* Patients with hypoxemia related to viral pneumonia (COVID-19) requiring oxygen or nasal high flow therapy (to maintain SpO2 above 92%) without criteria for immediate intubation or need for other respiratory supports (CPAP, non-invasive ventilation).
* Initiation of oxygen supplementation \< 72 hours
* eGFR (CKD EPI) \> 30 ml/min/1.73m2
* Serum troponin i \< 80 ng/L
* Heart rate ≥ 55 bpm if beta blockers or calcium channel blocker nondihydropyridine are used, and ≥ 60 bpm in the other patients
Exclusion criteria Medical conditions
* Level of care B (unless patient agrees to intubation at study enrollment), C or D (patient admitted for palliative care; or physician is not committed to life-sustaining therapies)
* No SpO2 signal available (only if FreeO2 apparatus is used)
* Patient agitation (only if FreeO2 apparatus is used)
* Severe untreated sleep apnea
* History of or currently active primary or secondary immunodeficiency
* Recent (within the last 6 months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, class III/IV heart failure
* Known presence of Mobitz type II second-degree or third-degree atrioventricular block, sick sinus syndrome, or sinoatrial block, unless patient has a functioning pacemaker
* Child-Pugh score class C
* Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin measured during screening
* Persistent hypotension.
Prior/concomitant therapy
* Receipt of a live vaccine within 4 weeks prior to randomization
* Receiving MAO inhibitor (tranylcypromine, selegiline or phenelzine)
* Receiving pharmacological treatment for a form of multiple sclerosis
* Use of long-term immunosuppressors (Ex. tacrolimus, cyclosporin, azathioprine, mycophenolate, sirolimus, methotrexate or chronic use of corticosteroid (\> 7.5 mg per day more than 3 months)
* Receiving Class Ia and class III anti-arrythmic drugs amiodarone, sotalol, flecainide, propafenone
* Patients receiving or anticipated to receive hydroxychloroquine or azithromycin.
Prior/concurrent clinical study experience -Current enrolment in an interventional arm of a clinical trial with similar endpoints to the COZI trial
Other exclusions
-Patients or legal/authorized representatives who refuse to participate to the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04405102
Study Brief:
Protocol Section:
NCT04405102