COVID-19 Antithrombotic Rivaroxaban Evaluation

• Status: Recruiting
• Trial end date: 2021-10-30
• Target enrollment: 0
• Participant gender: All

Summary

There are several ways in which the COVID-19 pandemic may affect the prevention and management of thrombotic and thromboembolic disease, either direct effect or the indirect effects of infection, such as through severe illness and hypoxia, may predispose patients to thrombotic events. The severe inflammatory response, critical illness, and underlying traditional risk factors may all predispose to thrombotic events. Therefore, considering the high-risk profile of cardiovascular comorbidities in patients with COVID-19, it is scientifically relevant to evaluate the use of anticoagulants as an adjunctive treatment in the context of COVID-19. Indeed, it will be tested the hypothesis that the use of moderate dose of rivaroxaban has a beneficial effect in the treatment of patients with a confirmed or probable diagnosis of COVID-19 infection, with no clear indication for hospitalization (mild and moderate cases) upon initial medical care, by reducing the need of hospitalization due to complications related to COVID-19.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Alemão Oswaldo Cruz
• Collaborators: Bayer; Brazilian Clinical Research Institute; Brazilian Research In Intensive Care Network; Hospital do Coracao; Hospital Israelita Albert Einstein; Hospital Moinhos de Vento; Hospital Sirio-Libanes
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

1. Adults ≥ 18 years old;

2. Evaluated in the emergency unit with probable or confirmed infection by COVID-19;

3. Time between symptoms and inclusion ≤ 07 days *;

4. Present mild or moderate signs and symptoms, with no clear indication for hospitalization;

5. Present at least 2 risk factors for complication:

• 65 years

• Hypertension

• Diabetes mellitus

• Asthma

• Chronic Obstructive Pulmonary Disease (COPD) or other chronic lung diseases

• Smoking

• Immunosuppression

• Obesity (BMI> 30)

• History of non-active cancer

• Bed restriction or reduced mobility (≥50% of the wake time without walking)

• Previous history of VTE

• Use of oral hormonal contraceptives

Exclusion Criteria:

1. Patients <18 years old;

2. Hospitalization indication upon first medical care;

3. Positive test for influenza in the first visit;

4. Any known liver disease associated with coagulopathy; INR (International Normalized Ratio) > 1.5;

5. Pregnant, lactating or with the possibility of becoming pregnant and without using an adequate contraceptive method;

6. High risk of bleeding; History of bronchiectasis or pulmonary cavitation, Significant bleeding in the last 3 months, Active gastroduodenal ulcer, history of recent bleeding (within 3 months) or a high risk of bleeding;

7. Stroke within 1 month or any history of hemorrhagic or lacunar stroke or any intracranial bleeding or any intracranial neoplasia, brain metastasis, arteriovenous malformation or brain aneurysm;

8. Severe heart failure with left ventricular ejection fraction <30% (echocardiogram or other validated method previously documented) or symptoms of heart failure class III or IV of the New York Heart Association (NYHA);

9. Estimated glomerular filtration rate (eGFR) <30 mL / min;

10. Clinical indication for dual antiplatelet therapy or anticoagulation therapy (VTE, atrial fibrillation / flutter, mechanical valve prosthesis);

11. Marked thrombocytopenia (platelets <50,000 / mm3);

12. Non-cardiovascular disease that is associated with a poor prognosis, for example, active cancer (excluding non-melanoma skin cancer) defined as cancer without remission or requiring active chemotherapy or adjuvant therapies such as immunotherapy or radiation therapy or that increases the risk of an adverse reaction to the evaluated interventions;

13. History of hypersensitivity or known contraindication to rivaroxaban;

14. Systemic treatment with strong inhibitors of Cytochrome P450 3A4 (CYP3A4) and glycoprotein p (Pgp) (for example, systemic azole antimycotics, such as ketoconazole and human immunodeficiency virus [HIV] protein inhibitors, such as ritonavir) or strong inducers of CYP 3A4, that is, rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine;

15. Current treatment being tested;

16. Concomitant participation in another study with experimental drugs in the context of COVID;

17. Use of chloroquine or hydroxychloroquine associated with azithromycin;

18. Active cancer;

19. Other contraindications to rivaroxaban;