COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04514627

Nader Kamangar, M.D.

nkamangar@dhs.lacounty.gov

2020-08-17

Unknown

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - 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.

- 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

2

Olive View-UCLA Education & Research Institute

18

100

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

100

Hypoxemia via oxygen level, or saturation (SpO2) in percent;Progression to mechanical ventilation, ECLS or death

None

Not reported

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