Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIORII)
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| ClinicalTrials.gov Identifier: NCT04382391 |
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Recruitment Status :
Active, not recruiting
First Posted : May 11, 2020
Last Update Posted : August 29, 2022
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| 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 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 21 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 |
| Actual Primary Completion Date : | July 21, 2021 |
| Estimated Study Completion Date : | December 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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Active Comparator: standard of care alone
Will receive standard of care therapies to treat CoViD-19 infection and symptoms
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Other: Standard of care therapies
Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms |
- 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. [ Time Frame: From the time of randomization up to assessed up to 3 months post discharge ]compare clinical events between the control group and active group for patients admitted to the hospital for CoViD-19.
- 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 TNF-α, IL-1β, IL-6, CRP, Ferritin, D-Dimer, Pro-Calcitonin
- 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.
- 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
- 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
- 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. [ Time Frame: From the time of enrollment up to 3 months post discharge ]based on a modified ordinal scale recommended by the WHO R&D Blueprint Group
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
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
| United States, Pennsylvania | |
| AHN Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| AHN West Penn Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Principal Investigator: | Tariq Cheema, MD | Allegheny Health Network | |
| Study Director: | Boyle Cheng, PhD | Allegheny Health Network |
| 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: | August 29, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn 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 Infections Respiratory Tract Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Injury |

