COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04762771

Raul E Herrera, MD

raulh@baptisthealth.net

2021-02-21

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: men and women ≥ 18 years of age covid-19 positive hospitalized patients able to provide informed consent cardiac injury (as evidenced by any of the following) elevated troponin level elevated bnp level new ischemic or arrhythmogenic ecg/telemetry changes new decrease in left ventricular ejection fraction (lvef) or new pericardial effusion on echocardiogram

pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes: intrauterine devices (iud), contraceptive implants, or tubal sterilization hormone method 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 history of severe hematologic or neuromuscular disorder co-administration of cytochrome p450 3a4 (cypa3a4) and p-glycoprotein transport inhibitor severe renal impairment with concomitant hepatic impairment concurrent use of colchicine and strong or p-glycoprotein inhibitor with renal or hepatic impairment

2

Baptist Health South Florida

18

99

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

2

Mechanical Circulatory Support;Mechanical Ventilation;Mortality

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]