Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT04368156
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2020-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-03-31', 'mcpReleaseN': 3, 'releaseDate': '2023-03-07'}, {'resetDate': '2023-05-09', 'mcpReleaseN': 4, 'releaseDate': '2023-05-09'}, {'resetDate': '2023-05-10', 'mcpReleaseN': 5, 'releaseDate': '2023-05-10'}], 'estimatedResultsFirstSubmitDate': '2023-03-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055536', 'term': 'Vagus Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2020-04-20', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of changes in specific clinical events in patients with covid-19.', 'timeFrame': 'From randomization to hospital discharge or ICU admission, whatever occurs first, assessed up to two months', 'description': 'The clinical events include, but are not limited, to:\n\n* Proportion of subjects requiring mechanical ventilation\n* Days to onset of mechanical ventilation\n* Oxygen support requirements\n* O2 saturation\n* Pain levels\n* PaO2/FiO2\n* Coagulation\n* Laboratory measurements related to circulating cytokines and inflammation.\n* Live discharge from the hospital\n* Patient length of stay\n* Mortality\n* Need for intensive care\n* Shortness of breath\n* Device related serious adverse events\n* Adverse events'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Covid-19']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '1 Staats, P., et al. (2018). In E.Krames, et. al (Eds.) Neuromodulation : Comprehensive Textbook of Principles, Technologies, and Therapies Vol 1: Neurostiumulation for Asthma (2nd Edition, pp. 1339-1345). London, United Kingdom: Academic Press, Elsevier.'}, {'pmid': '22506946', 'type': 'BACKGROUND', 'citation': 'Miner JR, Lewis LM, Mosnaim GS, Varon J, Theodoro D, Hoffmann TJ. Feasibility of percutaneous vagus nerve stimulation for the treatment of acute asthma exacerbations. Acad Emerg Med. 2012 Apr;19(4):421-9. doi: 10.1111/j.1553-2712.2012.01329.x.'}, {'pmid': '31138538', 'type': 'BACKGROUND', 'citation': 'Pavlov VA, Chavan SS, Tracey KJ. Bioelectronic Medicine: From Preclinical Studies on the Inflammatory Reflex to New Approaches in Disease Diagnosis and Treatment. Cold Spring Harb Perspect Med. 2020 Mar 2;10(3):a034140. doi: 10.1101/cshperspect.a034140.'}, {'pmid': '22151415', 'type': 'BACKGROUND', 'citation': 'Hoffmann TJ, Mendez S, Staats P, Emala CW, Guo P. Inhibition of histamine-induced bronchoconstriction in Guinea pig and Swine by pulsed electrical vagus nerve stimulation. Neuromodulation. 2009 Oct;12(4):261-9. doi: 10.1111/j.1525-1403.2009.00234.x. Epub 2009 Aug 20.'}, {'pmid': '27382171', 'type': 'BACKGROUND', 'citation': 'Koopman FA, Chavan SS, Miljko S, Grazio S, Sokolovic S, Schuurman PR, Mehta AD, Levine YA, Faltys M, Zitnik R, Tracey KJ, Tak PP. Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis. Proc Natl Acad Sci U S A. 2016 Jul 19;113(29):8284-9. doi: 10.1073/pnas.1605635113. Epub 2016 Jul 5.'}, {'pmid': '27957782', 'type': 'BACKGROUND', 'citation': 'Brock C, Brock B, Aziz Q, Moller HJ, Pfeiffer Jensen M, Drewes AM, Farmer AD. Transcutaneous cervical vagal nerve stimulation modulates cardiac vagal tone and tumor necrosis factor-alpha. Neurogastroenterol Motil. 2017 May;29(5). doi: 10.1111/nmo.12999. Epub 2016 Dec 12.'}, {'pmid': '30328647', 'type': 'BACKGROUND', 'citation': "Tarn J, Legg S, Mitchell S, Simon B, Ng WF. The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue and Immune Responses in Patients With Primary Sjogren's Syndrome. Neuromodulation. 2019 Jul;22(5):580-585. doi: 10.1111/ner.12879. Epub 2018 Oct 17."}, {'pmid': '26990318', 'type': 'BACKGROUND', 'citation': 'Lerman I, Hauger R, Sorkin L, Proudfoot J, Davis B, Huang A, Lam K, Simon B, Baker DG. Noninvasive Transcutaneous Vagus Nerve Stimulation Decreases Whole Blood Culture-Derived Cytokines and Chemokines: A Randomized, Blinded, Healthy Control Pilot Trial. Neuromodulation. 2016 Apr;19(3):283-90. doi: 10.1111/ner.12398. Epub 2016 Mar 15.'}, {'pmid': '17901837', 'type': 'BACKGROUND', 'citation': 'Huston JM, Gallowitsch-Puerta M, Ochani M, Ochani K, Yuan R, Rosas-Ballina M, Ashok M, Goldstein RS, Chavan S, Pavlov VA, Metz CN, Yang H, Czura CJ, Wang H, Tracey KJ. 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Cephalalgia. 2019 Aug;39(9):1180-1194. doi: 10.1177/0333102419833076. Epub 2019 Feb 20.'}, {'pmid': '21535457', 'type': 'BACKGROUND', 'citation': 'Fornai F, Ruffoli R, Giorgi FS, Paparelli A. The role of locus coeruleus in the antiepileptic activity induced by vagus nerve stimulation. Eur J Neurosci. 2011 Jun;33(12):2169-78. doi: 10.1111/j.1460-9568.2011.07707.x. Epub 2011 May 3.'}, {'pmid': '35463130', 'type': 'DERIVED', 'citation': 'Tornero C, Pastor E, Garzando MDM, Orduna J, Forner MJ, Bocigas I, Cedeno DL, Vallejo R, McClure CK, Czura CJ, Liebler EJ, Staats P. Non-invasive Vagus Nerve Stimulation for COVID-19: Results From a Randomized Controlled Trial (SAVIOR I). Front Neurol. 2022 Apr 8;13:820864. doi: 10.3389/fneur.2022.820864. eCollection 2022.'}, {'pmid': '32586395', 'type': 'DERIVED', 'citation': 'Tornero C, Vallejo R, Cedeno D, Orduna J, Pastor E, Belaouchi M, Escamilla B, Laredo M, Del Mar Garzando M. A prospective, randomized, controlled study assessing vagus nerve stimulation using the gammaCore(R)-Sapphire device for patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR): A structured summary of a study protocol for a randomised controlled trial". Trials. 2020 Jun 26;21(1):576. doi: 10.1186/s13063-020-04486-w.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to asses the efficacy of the Gammacore device reducing the need for mechanical ventilation in patients diagnosed of Covid-19'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has been tested positive or suspected/presumed positive for CoViD-19\n2. Patients with cough, shortness of breath or respiratory compromise (RR\\>24/min, increased work of breathing.)\n3. O2 Saturation less than or equal to 96% on room air or sensation\n4. Agrees to use the gammaCore®-Sapphire device as intended and to follow all of the requirements of the study including recording required study data\n5. Patient is able to provide signed and witnessed Informed Consent\n\nExclusion Criteria:\n\n1. On home/therapy oxygen (i.e. for COPD patients) at baseline prior to development of CoViD-19\n2. Is already enrolled in a clinical trial using immunotherapeutic regimen for CoViD-19\n3. Already gammaCore for other medical conditions\n4. A history of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma\n5. Known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (eg, bruits or history of transient ischemic attack or cerebrovascular accident), congestive heart failure, known severe coronary artery disease, or recent myocardial infarction\n6. Uncontrolled high blood pressure (\\>140/90)\n7. 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\n8. Current implantation of metal cervical spine hardware or a metallic implant near the gammaCore stimulation site\n9. 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)\n10. Compromised access to peripheral veinous for blood)\n11. Pregnant women'}, 'identificationModule': {'nctId': 'NCT04368156', 'acronym': 'SAVIOR', 'briefTitle': 'Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clínico Universitario de Valencia'}, 'officialTitle': 'A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIOR)', 'orgStudyIdInfo': {'id': 'SAVIOR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'Gammacore treatment', 'interventionNames': ['Device: gammaCore® (Vagus nerve stimulation)']}], 'interventions': [{'name': 'gammaCore® (Vagus nerve stimulation)', 'type': 'DEVICE', 'description': 'Vagus nerve stimulation using the gammacore neurostimulation device', 'armGroupLabels': ['Gammacore treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carlos Tornero', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Carlos Tornero', 'investigatorAffiliation': 'Hospital Clínico Universitario de Valencia'}}}}