Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms

Stopped early · Not applicable

Conditions studied: COVID, Corona Virus Infection, Respiratory Failure, Respiratory Distress Syndrome, Adult, ARDS, Human, SARS (Severe Acute Respiratory Syndrome)

In brief

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 (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore® (nVNS) treatments will be used acutely and prophylactically. The aims of this study are to summarize and compare the incidence of clinical events and pro-inflammatory cytokine levels in patients randomized to use of gammaCore Sapphire plus standard of care vs standard of care alone in patients hospitalized for CoViD-19. Secondary objectives are demonstrate the safety of gammaCore Sapphire use in patients hospitalized for CoViD-19.

Key facts

Study ID

NCT04382391

Run by

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

People needed

21

Starts

2020-05-15

Expected to finish

2023-04-13

Last updated by the study team

2024-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AHN Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• AHN West Penn Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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