Status:
COMPLETED
Vagus Nerve Stimulation ARDS Prevention Trial for COVID-19 Hospitalized Patients
Lead Sponsor:
Nemechek Technologies
Conditions:
Severe Acute Respiratory Syndrome Coronavirus 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial is designed to determine if the inflammation modulating effect of vagus nerve stimulation can improve pulmonary function and limit progression to ARDS in hospitalized COVID-19 hospitalized ...
Detailed Description
Patients hospitalized with COVID-19 predominantly die of organ failure due to a surge of pro-inflammatory cytokines triggering the need for mechanical ventilation, often due to acute respiratory distr...
Eligibility Criteria
Inclusion
- Patients who are 18 years of age
- Tested positive or suspected/presumed positive for COVID-19 infection
- Patients requiring hospital admission moderate to severe pneumonia and pneumopathy
- Patients showing fever and respiratory symptoms with radiological findings of pneumonia
- Respiratory distress (≧30 breaths/ min) or Oxygen saturation ≤93% at rest in ambient air; or oxygen saturation ≤97 % with O2 \> 5L/min
- Patient is able to provide signed and witnessed Informed Consent
Exclusion
- Already enrolled in a trial for COVID-19 therapy
- Potentially life threatening heart rhythm
- Pregnancy or potential pregnancy
- 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
- History of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma
- 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)
Key Trial Info
Start Date :
June 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04379037
Start Date
June 27 2020
End Date
November 1 2020
Last Update
June 4 2021
Active Locations (1)
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1
Hospital Zonal Virgen del Carmen de Zárate
Zárate, Buenos Aires, Argentina, B2800DDF