NCT04394377.

Study name	Randomized clinical trial to evaluate a routine full anticoagulation strategy in patients with coronavirus (COVID‐19) ‐ COALIZAO ACTION Trial
Starting date	21 June 2020
Contact information	Renato Delascio Lopes, MD, PhD Brazilian Clinical Research Institute, Sao Paulo, Brazil +55 11 5904 7339 | renato.lopes@duke.edu
Methods	Multicentre, quadruple masking (participant, care provider, investigator, outcomes assessor), investigator‐sponsored, 2‐armed, parallel‐assignment RCT
Participants	600 participants, ≥ 18 years, female and male Inclusion Patients with confirmed diagnosis of COVID‐19 admitted to hospital Onset of symptoms leading to hospitalisation < 14 days Patients ≥ 18 years D‐dimer ≥ 3 x the ULN Agreement to participate by providing the informed consent form Exclusion Patients with indication for full anticoagulation during inclusion (for example, diagnosis of VTE, 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 SBP of ≥ 180 mmHg or DBP of ≥100 mmHg INR > 1.5 Patients contraindicated to full anticoagulation (active bleeding, liver failure, blood dyscrasia or prohibitive haemorrhage risk as evaluated by the investigator) Criteria for DIC A history of haemorrhagic 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
Interventions	Experimental: routine full anticoagulation strategy. Rivaroxaban 20 mg/d followed by enoxaparin/UFH when needed Comparator: usual standard of care and currently have no indication of full anticoagulation. Control group with enoxaparin 40 mg/d
Outcomes	Primary 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 (time frame: In 30 days). The primary objective will be analysed using the win ratio approach comparing every participant of treatment group to every participant of control group to determine a winner. Secondary Incidence of VTE (time frame: 30 days) Incidence of acute myocardial infarction (time frame: 30 days) Incidence of stroke (time frame: 30 days) Number of days using oxygen therapy (time frame: 30 days) Peak of troponin (time frame: 30 days) Peak of D‐dimer (time frame: 30 days) Incidence of major bleeding and clinically relevant non‐major bleeding by the ISTH criteria (time frame: 30 days). It will be considered the main safety endpoint
Notes	NCT04394377 | No data provided