Table I.

Inclusion and exclusion criteria for ACTION trial

Inclusion criteria

1.Patients with confirmed diagnosis of COVID-19 admitted to hospital

2.Duration of symptoms related to hospitalization ≤14 days

3.Patients ≥18 year old

4.D-dimer above the ULN

5.Agreement to participate by providing the informed consent form

Exclusion criteria

6.Patients with indication for full-dose anticoagulation during inclusion (e.g, diagnosis of VTE, AF, mechanical valve prosthesis)

7.Platelets <50,000 /mm3

8.Use of ASA >100 mg per day

9.Use of P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor)

10.Chronic use of NSAIDs

11.Sustained uncontrolled systolic BP ≥180 mm Hg or diastolic BP ≥100 mm Hg

12.INR >1.5

13.Patients contraindicated to full-dose anticoagulation (active bleeding, liver failure, blood dyscrasia or prohibitive hemorrhage risk as evaluated by the investigator)

14.Patients with DIC

15.History of hemorrhagic stroke or any intracranial bleeding at any time in the past or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous malformation, or aneurysm

16.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

17.Hypersensitivity to rivaroxaban

18.Use of strong inhibitors of cytochrome P450 (CYP) 3A4 and/or P-gp (e.g., protease inhibitors, ketoconazole, itraconazole) and/or use of P-gp and strong CYP3A4 inducers (includng, but not limited to, rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort)

19.Known HIV infection

20.Creatinine clearance <30 mL/min

21.Pregnancy or breastfeeding

AF indicates atrial fibrillation; ASA, acetylsalicylic acid; BP, blood pressure; COVID-19, coronavirus 2019; DIC, disseminated intravascular coagulation; HIV, human immunodeficiency virus; NSAIDs, nonsteroidal anti-inflammatory drugs; P-gp, P-glycoprotein; ULN, upper limit of normal; VTE, venous thromboembolism.