Status:
COMPLETED
Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With COVID-19
Lead Sponsor:
Olive View-UCLA Education & Research Institute
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
COVID-19 is a disease caused by the virus, SARS-CoV-2. Patients with this viral infection are at risk for developing pneumonia and acute respiratory distress syndrome (ARDS). Approximately 20% to 30% ...
Eligibility Criteria
Inclusion
- Age ≥18 years at time of signing Informed Consent Form
- Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen, e.g., respiratory, blood, urine, stool, other bodily fluid) and per the investigator, the respiratory compromise is most likely due to COVID-19
- Patient complaint of dyspnea at the time of presentation to ED or hospital
- Patient on room air or oxygen supplementation of no greater than 4 liters at rest to maintaining pulse oximetry of 92% or greater. This can include oxygen supplementation by any modality (BIPAP, CPAP, HFNC, NRB, NC), with the exception of mechanical ventilation or ECLS.
- Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative
- Ability to comply with the study protocol in the investigator's judgment.
Exclusion
- Patients who cannot provide informed consent
- History of surgery involving CN V, VII, IX, or X.
- Patient on chronic renal dialysis
- Patients with history of solid organ transplant
- Patients with underlying seizures disorder
- Patients with a cardiac pacemaker
- Patients with any implanted electrical device
- Patients with dermatologic conditions affecting the ear, face, or neck region (i.e. psoriasis), or with cuts or abrasions to the external ear that would interfere with needle placement
- Patients with hemophilia or other bleeding disorders
- Patients who are pregnant or breastfeeding
- Patients with active TB infection
- Patient already on mechanical ventilation or ECLS
- Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
- In the opinion of the investigator, progression to mechanical ventilation, ECLS or death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- Participating in other drug clinical trials
- ALT or AST \> 5 x ULN detected within 24 hours at screening or at baseline (according to local laboratory reference ranges)
- ANC \< 500/µL at screening and baseline (according to local laboratory reference ranges)
- Platelet count \< 50,000/µL at screening and baseline (according to local laboratory reference ranges)
- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04514627
Start Date
July 13 2020
End Date
March 22 2022
Last Update
June 13 2024
Active Locations (1)
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1
Olive View-UCLA Medical Center
Sylmar, California, United States, 91342