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Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIORII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04382391
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
ElectroCore INC
Information provided by (Responsible Party):
Tariq Cheema, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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 (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 active and control groups will be diseased and severity matched.

The primary objective is to reduce initiation of mechanical ventilation in patients with CoViD-19 compared to the control group. Secondary objectives are to evaluate cytokine trends/prevent cytokine storms, evaluate supplemental oxygen requirements, decrease mortality of CoViD-19 patients and to delay the onset of mechanical ventilation.


Condition or disease Intervention/treatment Phase
COVID Corona Virus Infection Respiratory Failure Respiratory Distress Syndrome, Adult ARDS, Human SARS (Severe Acute Respiratory Syndrome) Device: gammaCore® Sapphire (non-invasive vagus nerve stimulator) Other: Standard of care therapies Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized, Controlled
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIORII)
Actual Study Start Date : May 8, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : December 30, 2021


Arm Intervention/treatment
Experimental: gammaCore Sapphire® (nVNS) plus standard of care
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
Device: gammaCore® Sapphire (non-invasive vagus nerve stimulator)

Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.

For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment.


Other: Standard of care therapies
Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms

Active Comparator: standard of care alone
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
Other: Standard of care therapies
Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms




Primary Outcome Measures :
  1. change in initiation of mechanical ventilation in patients with CoViD-19 compared to the control group. [ Time Frame: 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 ]
    measure the change (in hours) between the control group and treatment group


Secondary Outcome Measures :
  1. evaluate cytokine trends [ Time Frame: 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 ]
    measure the changes in the serum/plasma concentrations of TH1 and TH2-type cytokines

  2. evaluate supplemental oxygen requirements [ Time Frame: 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 ]
    compare the difference in oxygen requirements (liters/min) between the control group and active group for patients admitted to the hospital for CoViD-19.

  3. decrease mortality of CoViD-19 patients [ Time Frame: 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 ]
    measure the change (in hours) to death between control group and treatment group

  4. delay onset of ventilation [ Time Frame: 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 ]
    measure the change (in hours) to time of mechanical ventilation between control group and treatment group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382391


Contacts
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Contact: AHN Research Institute 412-330-6151 clinicaltrials@ahn.org

Locations
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United States, Pennsylvania
AHN Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Clinical Trials Contact    412-330-6151    clinicaltrials@ahn.org   
AHN West Penn Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Clinical Trials Contact    412-330-6151    clinicaltrials@ahn.org   
Sponsors and Collaborators
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
ElectroCore INC
Investigators
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Principal Investigator: Tariq Cheema, MD Allegheny Health Network
Study Director: Boyle Cheng, PhD Allegheny Health Network
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Responsible Party: Tariq Cheema, Associate Division Director, AHN Pulmonary, Critical Care and Sleep Medicine, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
ClinicalTrials.gov Identifier: NCT04382391    
Other Study ID Numbers: 2020-132-AGH
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Syndrome
Signs and Symptoms, Respiratory
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Lung Injury