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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT04953234
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years.
2. Hospitalized with diagnosis of COVID-19 infection per reverse transcription polymerase chain reaction (RT-PCR) within 72 hours prior to treatment start.
3. SpO2 ≤ 93% at sea level.
4. Lung involvement confirmed with chest imaging.
5. Able and willing to comply with all study procedures.
6. Female participants of childbearing age must use highly effective contraception.
7. All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
Exclusion Criteria:
1. Receipt of any experimental treatment for COVID-19 prior to or during the study.
2. Assisted ventilation.
3. Critical illness: respiratory failure defined as oxygen saturation by pulse oximetry/inspired oxygen fraction (SpO2/FiO2) ratio \< 150, septic shock, and/or multiple organ dysfunction.
4. Significant co-morbidities at baseline as determined by the investigator:
1. Clinically significant hematological, hepatic and renal dysfunction, defined as: Neutrophil count \< 1.5 x 10\^9/L and platelet count \< 100 x 10\^9/L; bilirubin \> 1.5 x upper limit of normal (ULN); aspartate aminotransferase (AST) and/or alanine transaminase (ALT) \> 2.5 x ULN; and serum creatinine \> 2.5 mg/dL.
2. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class IV (unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases).
3. History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the study.
4. History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent.
5. Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso.
6. Pregnancy or breast-feeding.
7. Known allergies to medical adhesives or hydrogel.
8. Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's cooperation or other unspecified reasons that, in the opinion of the Investigator or sponsor, make the subject's enrollment incompatible with study objectives.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04953234
Study Brief:
Protocol Section:
NCT04953234