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:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT04606069
Eligibility Criteria:
Inclusion Criteria:
* Age: adults 18 years and older
* Laboratory-confirmed COVID-19+ by RT-PCR
* Moderate to Severe COVID-19 patients according to FDA's COVID-19 treatment guideline on Management of Persons with COVID-19: Moderate illness is defined as individuals who have evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen (SpO2) \>93% on room air at sea level. Severe Illness is defined as individuals who have respiratory frequency \>30 breaths per minute, SpO2 ≤ 93% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<300, or lung infiltrates \>50%
* Written informed consent must be obtained before any study procedure is performed.
Exclusion Criteria:
* Pregnant or breastfeeding women
* Symptoms or signs of acute myocardial ischemia
* Sinoatrial (SA) and Atrioventricular (AV) Nodal Block/dysfunction
* Symptoms or signs of Atrial Fibrillation/Atrial Flutter
* History of Hypotension
* History of severe hypertension not adequately controlled with anti-hypertensive medications (Systolic blood pressure ≥ 200 mmHg and/or Diastolic blood pressure ≥ 110 mmHg)
* Severe renal impairment defined as glomerular filtration rate (GFR) \< 30 ml/min
* History of clinically overt stroke within the past 3 years
* History of seizure disorder
* Pre-existing asthma or chronic obstructive pulmonary disease
* Chronic anti-coagulation or anti-platelet therapy that would preclude surgery (prophylactic aspirin is acceptable)
* 12.Treatment within 30 days with Hydroxychloroquine (HCQ) or Azithromycin
* Treatment with Janus Kinase inhibitors
* Treatment with theophylline or aminophylline within 12 hours of study dosing
* Treatment with Persantine and/or Aggrenox within 5 days
* Other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04606069
Study Brief:
Protocol Section:
NCT04606069