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Status:

TERMINATED

COVID-19 Antithrombotic Rivaroxaban Evaluation

Lead Sponsor:

Hospital Alemão Oswaldo Cruz

Collaborating Sponsors:

Bayer

Hospital Israelita Albert Einstein

Conditions:

COVID-19

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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...

Detailed Description

Initial studies suggest an inflammatory state and hypercoagulation in individuals with COVID-19. Apparently, the fact that the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protei...

Eligibility Criteria

Inclusion

  • Adults ≥ 18 years old;
  • Evaluated in the emergency unit with probable or confirmed infection by COVID-19;
  • Time between symptoms and inclusion ≤ 07 days \*;
  • Present mild or moderate signs and symptoms, with no clear indication for hospitalization;
  • 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

  • Patients \<18 years old;
  • Hospitalization indication upon first medical care;
  • Positive test for influenza in the first visit;
  • Any known liver disease associated with coagulopathy; INR (International Normalized Ratio) \> 1.5;
  • Pregnant, lactating or with the possibility of becoming pregnant and without using an adequate contraceptive method;
  • 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;
  • 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;
  • 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);
  • Estimated glomerular filtration rate (eGFR) \<30 mL / min;
  • Clinical indication for dual antiplatelet therapy or anticoagulation therapy (VTE, atrial fibrillation / flutter, mechanical valve prosthesis);
  • Marked thrombocytopenia (platelets \<50,000 / mm3);
  • 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;
  • History of hypersensitivity or known contraindication to rivaroxaban;
  • 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;
  • Current treatment being tested;
  • Concomitant participation in another study with experimental drugs in the context of COVID;
  • Use of chloroquine or hydroxychloroquine associated with azithromycin;
  • Active cancer;
  • Other contraindications to rivaroxaban;

Key Trial Info

Start Date :

September 29 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 30 2022

Estimated Enrollment :

660 Patients enrolled

Trial Details

Trial ID

NCT04757857

Start Date

September 29 2020

End Date

August 30 2022

Last Update

January 25 2023

Active Locations (36)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 9 (36 locations)

1

Hospital Maternidade São Vicente de Paulo

Barbalha, Ceará, Brazil

2

Clínica Senhor do Bonfim

Feira de Santana, Estado de Bahia, Brazil

3

Hospital de Base do Distrito Federal

Brasília, Federal District, Brazil

4

Hospital de Campanha Covid-19 Goiânia/Sesgo

Goiânia, Goiás, Brazil