COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04382391

Tariq Cheema

clinicaltrials@ahn.org

2020-05-11

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: patients (age 18 years and older) who have tested positive or suspected/presumed positive for covid-19 using pcr real time test patients with cough, shortness of breath or respiratory compromise (rr>24/min, increased work of breathing.) o2 saturation less than or equal to 96% on room air or sensation agrees to use the gammacore sapphire device as intended and to follow all of the requirements of the study including recording required study data permission for early am blood draw to freeze for subsequent lab tests and sequencing as related to covid-19 sequelae patient is able to provide signed and witnessed informed consent

on home/therapy oxygen (i.e. for chronic obstructive pulmonary disease (copd) patients) at baseline prior to development of covid-19 already using gammacore® (nvns) for other medical conditions a history of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g., bruits or history of transient ischemic attack or cerebrovascular accident), congestive heart failure, known severe coronary artery disease, myocardial infarction documented within past 90 days, or current or recent history of life-threatening arrhythmia (sustained ventricular tachycardia, ventricular fibrillation, second or third-degree heart block, uncontrolled atrial fibrillation or uncontrolled atrial flutter) patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia (as per investigator discretion) current implantation of an electrical and/or neurostimulator device, including but not limited to a cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant current implantation of metal cervical spine hardware or a metallic implant near the gammacore® stimulation site belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled and prisoner) compromised access to peripheral veins for blood sampling. pregnant women patients with active cancer or those who have had recent cancer treatment

2

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

18

None

United States

Moderate disease at enrollment

3: Moderate disease at enrollment

21

Number of Participants With Clinical Events

None

Not reported

[{"arm_notes": "", "treatment_id": 536, "treatment_name": "Gammacore non-invasive vagus nerve stimulator", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]