COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04606069

Melissa Culligan, RN

mculligan@som.umaryland.edu

2020-10-28

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - age: adults 18 years and older - laboratory-confirmed covid-19+ by rt-pcr - moderate to severe covid-19 patients according to fda's covid-19 treatment guideline on management of persons with covid-19: moderate illness is defined as individuals who have evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen (spo2) >93% on room air at sea level. severe illness is defined as individuals who have respiratory frequency >30 breaths per minute, spo2 ≤ 93% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) <300, or lung infiltrates >50% - written informed consent must be obtained before any study procedure is performed.

- pregnant or breastfeeding women - symptoms or signs of acute myocardial ischemia - sinoatrial (sa) and atrioventricular (av) nodal block/dysfunction - symptoms or signs of atrial fibrillation/atrial flutter - history of hypotension - history of severe hypertension not adequately controlled with anti-hypertensive medications (systolic blood pressure ≥ 200 mmhg and/or diastolic blood pressure ≥ 110 mmhg) - severe renal impairment defined as glomerular filtration rate (gfr) < 30 ml/min - history of clinically overt stroke within the past 3 years - history of seizure disorder - pre-existing asthma or chronic obstructive pulmonary disease - chronic anti-coagulation or anti-platelet therapy that would preclude surgery (prophylactic aspirin is acceptable) - 12.treatment within 30 days with hydroxychloroquine (hcq) or azithromycin - treatment with janus kinase inhibitors - treatment with theophylline or aminophylline within 12 hours of study dosing - treatment with persantine and/or aggrenox within 5 days - other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study

2

University of Maryland, Baltimore

18

100

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

40

Proportion of patients alive and free of respiratory failure through the 30-day trial.

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 1093, "treatment_name": "Regadenoson", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}]