Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy: The MICHELLE Trial

• Status: Active, not recruiting
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Science Valley Research Institute
• Collaborator: Bayer
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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