Status:
TERMINATED
Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms
Lead Sponsor:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborating Sponsors:
ElectroCore INC
Conditions:
COVID
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVN...
Detailed Description
Vagus nerve stimulation (VNS) has an established history of reducing airway distress. VNS has at least two mechanisms of action that may profoundly affect respiratory function in patients with respira...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04382391
Start Date
May 15 2020
End Date
April 13 2023
Last Update
May 1 2024
Active Locations (2)
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1
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
2
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224