Status:
COMPLETED
Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy: The MICHELLE Trial
Lead Sponsor:
Science Valley Research Institute
Collaborating Sponsors:
Bayer
Conditions:
Covid19
Venous Thromboembolism
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
The Michelle trial is expected to provide high-quality evidence around the role of extended thromboprophylaxis in COVID-19 and will help guide medical decisions in clinical practice.
Detailed Description
Background: The devastating COVID-19 pandemic is associated with a high prothrombotic state. It is unclear if the coagulation abnormalities occur because of the direct effect of SARS-CoV 2 or indirect...
Eligibility Criteria
Inclusion
- Male and nonpregnant female patients 18 years of age or older
- Positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for SARS-CoV-2 in a respiratory tract sample
- Pneumonia confirmed by chest imaging
- Additional risk factors for VTE, as indicated by a total modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) risk score of 4 or higher
- Have received thromboprophylaxis with low-molecular-weight heparin, fondaparinux, or unfractionated heparin during the index hospitalization
Exclusion
- Age \< 18 years
- Refusal of informed consent
- Physician decision that involvement in the trial was not in the patient's best interest
- Patients with a medical indication for anticoagulation therapy at the time of inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis)
- Platelets \< 50,000 / mm3
- Patients with contraindications to anticoagulation (active bleeding, liver failure, blood dyscrasia, or prohibitive hemorrhagic risk in the investigator's assessment)
- 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.
- Use of strong inhibitors of cytochrome P450 (CYP) 3A4 and/or glycoprotein P (P-gp) (eg protease inhibitors, ketoconazole, Itraconazole) and/or use of P-gp and strong inducers of CYP3A4 (how but not limiting rifampicin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine or St. John's wort)
- Creatinine clearance \<30 ml / min
- Pregnancy or breastfeeding
- known HIV infection
- Presence of one of the following uncontrolled or unstable cardiovascular diseases: stroke, ECG confirmed acute ischemia or myocardial infarction, and/or clinically significant dysrhythmia
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04662684
Start Date
October 16 2020
End Date
August 30 2021
Last Update
April 6 2022
Active Locations (1)
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1
Science Valley Research Institute
Santo André, São Paulo, Brazil, 09030370