Trial site and patients
ascites, chronic kidney disease, heart block, respiratory failure, Stage, thromboembolic, cough, pericardial effusion, arrythmias, human immunodeficiency virus, end-stage organ disease, shortness of breath
CHRONIC HEART FAILURE, ASCITES, HUMAN IMMUNODEFICIENCY VIRUS, HEART BLOCK, ADVERSE EVENTS, RESPIRATORY FAILURE, PERICARDIAL EFFUSION
The trial was conducted at the University of Utah Hospital from September 2020 until June 2022. Adults (age ≥ 18 years) admitted to the hospital were screened for enrollment. Briefly, patients were eligible if they were diagnosed as COVID-19 positive by a reverse transcriptase polymerase chain reaction (RT-PCR) test within 14 days of enrollment. These patients were symptomatic with COVID-19 (defined as cough, fevers, shortness of breath and/or sputum production), required supplemental oxygen As this was a Phase I/II trial in which we examined safety outcomes, and at the guidance of the FDA, we designed the trial to avoid enrolling patients who already had severe COVID-19 at enrollment, so as to minimize the chance that severe adverse events from COVID would confound the assessment of the intervention’s safety profile. Thus, patients were excluded if, prior to enrollment, they were already on mechanical ventilation (non-invasive or invasive), utilized chronic at home oxygen, were on home immunosuppressives, had impending respiratory failure (in the opinion of the investigator), had a hemoglobin < 9 g/deciliter (g/dL), chronic kidney disease (Stage ≥ 4), chronic heart failure (Class ≥ 3), durable left ventricular assist device, current thromboembolic phenomena, Type 2 or greater heart block, positive bacterial cultures, pericardial effusion or ascites, clinically significant arrythmias, liver function tests ≥ 3 × upper limit of normal, untreated human immunodeficiency virus, or other end-stage organ disease. Further details are given in the In February 2021, after the publication of the RECOVERY Trial, which showed a mortality benefit to dexamethasone during hospitalized COVID-19 [