Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms

NCT04382391 | Terminated Results DMC FDA Device

• 1 other identifier: 2020-132-AGH
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Events

  compare clinical events between the control group and active group for patients admitted to the hospital for CoViD-19.

  From baseline to 90 days post-discharge

Secondary Outcomes (11)

• Evaluate C-reactive Protein (CRP) Trends

  From baseline to discharge from hospital or death while hospitalized (patients had data for up to 6.2 days on average after baseline for these outcomes)

• Evaluate Supplemental Oxygen Requirements

  From baseline to discharge from hospital or death while hospitalized (patients had data for up to 6.2 days on average after baseline for these outcomes)

• Number of Participant Deaths

  From baseline to discharge from hospital or death while hospitalized (patients had data for up to 6.2 days on average after baseline for these outcomes)

• Time to Onset of Mechanical Ventilation

  From baseline to discharge from hospital or death while hospitalized

• Compare Clinical Improvement in Participants

  From baseline to discharge from hospital or death while hospitalized (data not collected during the study for this outcome)

Study Arms (2)

gammaCore Sapphire® (nVNS) plus standard of care

EXPERIMENTAL

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); Other: Standard of care therapies

standard of care alone

ACTIVE COMPARATOR

Will receive standard of care therapies to treat CoViD-19 infection and symptoms

Other: Standard of care therapies

Interventions

gammaCore® Sapphire (non-invasive vagus nerve stimulator) DEVICE

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.

gammaCore Sapphire® (nVNS) plus standard of care

Standard of care therapies OTHER

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

gammaCore Sapphire® (nVNS) plus standard of care; standard of care alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• ElectroCore INC: collaborator

Study Sites (2)

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

AHN West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; Respiratory Insufficiency; Respiratory Distress Syndrome; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Infections

Limitations and Caveats

Enrollment slowed as number of inpatient Covid cases decreased and the number of experimental therapies increased, thus creating it difficult to enroll. New and approved treatment options became available for this population, thus it was determined to close enrollment in this trial prior to meeting enrollment goal. Early termination lead to smaller number of subjects analyzed.

Results Point of Contact

• Title: Tariq Cheema, MD, Vice President and Medical Director AHN Research Institute
• Organization: Allegheny Health Network (AHN)

tariq.cheema@ahn.org

412-321-3344

Study Officials

• Tariq Cheema, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

• Boyle Cheng, PhD

  Allegheny Health Network

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Division Director, AHN Pulmonary, Critical Care and Sleep Medicine

Model Details: Prospective, Randomized, Controlled

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: May 11, 2020
• Study Start: May 15, 2020
• Primary Completion: August 22, 2022
• Study Completion: April 13, 2023
• Last Updated: May 1, 2024
• Results First Posted: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)