COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04394377

Renato D. Lopes

renato.lopes@duke.edu

2020-05-19

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - patients with confirmed diagnosis of covid-19 admitted to hospital; - duration of symptoms related to hospitalization ≤ 14 days; - patients ≥ 18 year old; - d-dimer above the upper limit of normal (collected until 72 hours before the randomization); - agreement to participate by providing the informed consent form (icf).

- patients with indication for full anticoagulation during inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis); - platelets < 50,000 /mm3 - need for asa therapy > 100 mg; - need for p2y12 inhibitor therapy (clopidogrel, ticagrelor or prasugrel); - chronic use of non-hormonal anti-inflammatory drugs; - sustained uncontrolled systolic blood pressure (bp) of ≥180 mmhg or diastolic bp of ≥100 mmhg; - inr > 1,5; - patients contraindicated to full anticoagulation (active bleeding, liver failure, blood dyscrasia or prohibitive hemorrhage risk as evaluated by the investigator); - criteria for disseminated intravascular coagulation (dic); - a history of hemorrhagic stroke or any intracranial bleeding at any time in the past or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (av) malformation, or aneurysm; - active cancer (excluding non-melanoma skin cancer) defined as cancer not in remission or requiring active chemotherapy or adjunctive therapies such as immunotherapy or radiotherapy; - hypersensitivity to rivaroxaban; - use of strong inhibitors of cytochrome p450 (cyp) 3a4 and/or p-glycoprotein (p-gp) (e.g. protease inhibitors, ketoconazole, itraconazole) and/or use of p-gp and strong cyp3a4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or st. john's wort); - known hiv infection; - creatinine clearance < 30 ml/min according to the cockcroft-gault formula; - pregnancy or breastfeeding.

2

Brazilian Clinical Research Institute

18

None

Brazil

No restriction on type of patients

0: No restriction on type of patients

615

Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days.

None

Phase 4

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