COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04497389

Craig Selzman, MD

craig.selzman@hsc.utah.edu

2020-08-04

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: age >18 sars cov-2 laboratory positive test, obtained within 14 days of enrollment hospitalized covid-19 symptomatic (cough, fevers, shortness of breath, and/or sputum production) has a room air pulse oximetry of ≤94% and requires supplemental oxygen therapy patients of childbearing potential who agree to use acceptable methods of contraception for 90 days after last administration of study ip patients who are receiving standard of care therapies for covid-19 that are not fda approved are eligible for this study subjects must be able to consent to the study (i.e., glasgow coma scale score of ≥14) patients are required to have controlled blood pressure of <160/96 and a pulse of <110.

patients on invasive mechanical ventilation (e.g., endotracheal intubation) chronic home oxygen utilization home or current use of immunosuppressive medications (including steroids) women who are pregnant, breastfeeding, or become pregnant during the study patients on non-invasive positive pressure ventilation patients on >12 liters per minute via non-rebreather (nrb) or >80% oxygen via high flow nasal cannula patients who, in the opinion of the pi, have impending respiratory failure, defined as requiring rapidly escalating oxygen supplementation patients with a hemoglobin <9 mg/dl patients diagnosed with stage 4 or 5 chronic kidney disease (ckd) patients with diagnosed nyha class 4 or 5 congestive heart failure patients with a left ventricular assist device (lvad) patients with thromboembolic phenomena patients with type 2 and above heart block patients with established positive bacterial blood cultures prior to enrollment patients with ongoing pericardial effusion or ascites patients with clinically significant arrhythmia patients with liver function tests (alt or ast) >3x normal patients with untreated hiv infection patients diagnosed with end-stage organ disease

2

University of Utah

18

100

United States

Moderate disease at enrollment

3: Moderate disease at enrollment

60

C-reactive protein

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 590, "treatment_name": "Human amniotic fluid", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]