COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04426344

Anne Drewry, MD

Katie Dalton, cmdalton@wustl.edu (PI email not reported)

2020-06-11

Withdrawn

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: patients above the age of 18 years old. patients with a diagnosis of covid-19 on mechanical ventilation. patient maximum baseline temperature (within previous 12 hours) < 38.3°c. patients must have a surrogate or legally authorized representative able to understand and critically review the informed consent form.

patients without surrogate or legally authorized representative able to provide informed consent. patients with contraindication to core warming using an esophageal core warming device. patients known to be pregnant. patients with <40 kg of body mass. patients with dnr status. patients with acute stroke, post-cardiac arrest, or multiple sclerosis. patients with history of esophageal disease patients with a baseline epinephrine dose greater than 0.6 mcg/kg/min patients with atrial fibrillation, atrial flutter, or other multifocal atrial tachycardia with a heart rate greater than 110 beats per minute. patients on 0.2 mcg/kg/min or more of norepinephrine

2

Washington University School of Medicine

18

100

United States

Critical disease at enrollment

8: Critical disease at enrollment

0

Viral load measured in tracheal aspirate 72 hours after initiation of core warming

None

Not reported

[{"arm_notes": "", "treatment_id": 326, "treatment_name": "Core warming with ensoetm device", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]