Respiratory Failure Clinical Trial
— SAVIORIIOfficial title:
A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIORII)
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.
Status | Active, not recruiting |
Enrollment | 21 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients (age 18 years and older) who have tested positive or suspected/presumed positive for CoViD-19 using PCR real time test 2. Patients with cough, shortness of breath or respiratory compromise (RR>24/min, increased work of breathing.) 3. O2 Saturation less than or equal to 96% on room air or sensation 4. Agrees to use the gammaCore Sapphire device as intended and to follow all of the requirements of the study including recording required study data 5. Permission for early am blood draw to freeze for subsequent lab tests and sequencing as related to CoViD-19 sequelae 6. Patient is able to provide signed and witnessed Informed Consent Exclusion Criteria: 1. On home/therapy oxygen (i.e. for chronic obstructive pulmonary disease (COPD) patients) at baseline prior to development of CoViD-19 2. Already using gammaCore® (nVNS) for other medical conditions 3. A history of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma 4. 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) 5. Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia (as per investigator discretion) 6. 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 7. Current implantation of metal cervical spine hardware or a metallic implant near the gammaCore® stimulation site 8. 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) 9. Compromised access to peripheral veins for blood sampling. 10. Pregnant women 11. Patients with active cancer or those who have had recent cancer treatment |
Country | Name | City | State |
---|---|---|---|
United States | AHN Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | AHN West Penn Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | ElectroCore INC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | summarize and compare the incidence of clinical events in patients randomized to use of gammaCore Sapphire plus standard of care vs standard of care alone in patients hospitalized for CoViD-19. | compare clinical events between the control group and active group for patients admitted to the hospital for CoViD-19. | From the time of randomization up to assessed up to 3 months post discharge | |
Secondary | evaluate cytokine trends | measure the changes in the serum/plasma concentrations of TNF-a, IL-1ß, IL-6, CRP, Ferritin, D-Dimer, Pro-Calcitonin | From the time of initial blood draw until the time of final blood draw, assessed up to date of mechanical ventilation, death, or discharge from hospital, whichever occurs first,assessed up to 3 months | |
Secondary | evaluate supplemental oxygen requirements | compare the difference in oxygen requirements (liters/min) between the control group and active group for patients admitted to the hospital for CoViD-19. | From the time of randomization, assessed up to time of mechanical ventilation, day of discharge or death, whichever occurs first, assessed up to 3 months | |
Secondary | decrease mortality of CoViD-19 patients | measure the change (in hours) to death between control group and treatment group | From the time or randomization until the date of death from any cause, assessed up to day of discharge or death,assessed up to 3 months | |
Secondary | delay onset of ventilation | measure the change (in hours) to time of mechanical ventilation between control group and treatment group | From the time of randomization until the time of initiation of mechanical ventilation, assessed up to day of discharge or death, whichever occurs first, assessed up to 3 months | |
Secondary | compare clinical improvement in patients randomized to use of gammaCore Sapphire plus standard of care vs standard of care alone in patients hospitalized for CoViD-19. | based on a modified ordinal scale recommended by the WHO R&D Blueprint Group | From the time of enrollment up to 3 months post discharge |
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