COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04355143

Reza Ardehali

Not reported

2020-04-21

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - confirmed covid-19 infection by polymerase chain reaction - cardiac injury, including any of the following: - elevated troponin level - elevated b-type natriuretic peptide (bnp) level - new ischemic or arrhythmogenic changes on ecg/telemetry - new decrease in left ventricular ejection fraction (lvef) or new pericardial effusion on echocardiogram - able to provide informed consent

pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use 2 forms of contraception, which includes: intrauterine devices (iud), contraceptive implants, or tubal sterilization hormone methods with a barrier method two barrier methods if a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction co-administration of cytochrome p450 3a4 (cypa3a4) and p-glycoprotein (p-gp) transport system inhibitors concurrent use of strong cyp3a4 or p-gp inhibitors in patients with renal or hepatic impairment; severe hematologic or neuromuscular disorders severe renal impairment with concomitant hepatic impairment

2

University of California, Los Angeles

18

100

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

93

Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS)

None

Phase 2

[{"arm_notes": "nan", "treatment_id": 1469, "treatment_name": "Colchicine+edoxaban", "treatment_type": "Metabolic agents+coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]