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

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ClinicalTrials.gov Identifier: NCT04662684
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : December 10, 2020
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Eduardo Ramacciotti, Science Valley Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Venous Thromboembolism Drug: Rivaroxaban 10 MG Phase 3

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 indirectly by the cytokine storm and endothelial damage, or by a combination of mechanisms. There is a clear indication of in-hospital pharmacological thromboprophylaxis for every patient with COVID-19 after bleed risk assessment. However, there is much debate regarding the best dosage regimen, and there is no consensus on the role of extended VTE prophylaxis.

Design: This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg OD for 35+/-4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization, with a composite efficacy endpoint of symptomatic VTE, VTE-related death, and/or VTE detected by mandatory bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35+/-4 post-hospital discharge.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study aims to evaluate the safety and efficacy of rivaroxaban 10 mg OD for 35+/-4 days versus no intervention after hospital discharge in COVID-19 patients who were at increased risk for VTE and have received standard parenteral VTE prophylaxis during hospitalization, with a composite efficacy endpoint of symptomatic VTE, VTE-related death, and/or VTE detected by mandatory bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35+/-4 post-hospital discharge.
Masking: None (Open Label)
Masking Description: open-label
Primary Purpose: Prevention
Official Title: Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy: The MICHELLE Trial
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
Drug Information available for: Rivaroxaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rivaroxaban
Rivaroxaban 10mg OD for 35+/- 4 days post-hospital discharge
 Drug: Rivaroxaban 10 MG
No intervention
Other Name: No intervention
No Intervention: No intervention
control


Outcome Measures
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Primary Outcome Measures :
  1. Venous thromboembolism and VTE related-death [ Time Frame: at day 35 +/- post hospital discharge ]
    a composite efficacy endpoint of symptomatic VTE, VTE-related death, and/or VTE detected by mandatory bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35+/-4 post-hospital discharge


Secondary Outcome Measures :
  1. Major bleeding [ Time Frame: at day 35 +/- post hospital discharge ]
    Incidence of major bleeding according to ISTH criteria.


Other Outcome Measures:
  1. A composite of myocardial infarction, stroke, arrhythmias, heart failure, venous thromboembolism (VTE), and all-cause death. [ Time Frame: at day 35 +/- post hospital discharge ]
    A composite of myocardial infarction, stroke, arrhythmias, heart failure, venous thromboembolism (VTE), and all-cause death.

  2. Days alive out of the hospital (DAOH) at 35 +/-4 days [ Time Frame: at day 35 +/- post hospital discharge ]
    Days alive out of the hospital (DAOH) at 35 +/-4 days

  3. D-dimer (Biomarker) [ Time Frame: at day 35 +/- 4 post hospital discharge ]
    plasma level of D-dimers in ng/mL

  4. C reactive protein (Biomarker) [ Time Frame: at day 35 +/- 4 post hospital discharge ]
    plasma level of C Reactive Protein in μg/mL

  5. PAI-1 (Biomarker) [ Time Frame: at day 35 +/- 4 post hospital discharge ]
    plasma level of PAI-1 in units/mL

  6. TFPI (Biomarker) [ Time Frame: at day 35 +/- 4 post hospital discharge ]
    plasma level of TFPI in units/mL

  7. Thrombomodulin (Biomarker) [ Time Frame: at day 35 +/- 4 post hospital discharge ]
    plasma level of Thrombomodulin in nM/mL

  8. IL-6 (Biomarker) [ Time Frame: at day 35 +/- 4 post hospital discharge ]
    plasma level of IL-6 in pg/mL


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662684


Contacts
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Contact: Eduardo Ramacciotti, MD, PhD +551144688183 ramacciotti@svriglobal.com
Contact: Leandro Agati, PhD +551144688183 agati@svriglobal.com

Locations
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Brazil
Science Valley Research Institute Recruiting
Santo André, São Paulo, Brazil, 09030370
Contact: Leandro Agati, PhD    +551144688183    agati@svriglobal.com   
Contact: Eduardo Ramacciotti, MD, PhD    +551144688183    ramacciotti@svriglobal.com   
Sponsors and Collaborators
Science Valley Research Institute
Bayer
Investigators
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Study Chair: Eduardo Ramacciotti, MD, Ph.D Science Valley Research Institute
More Information
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Responsible Party: Eduardo Ramacciotti, Principal Investigator, Science Valley Research Institute
ClinicalTrials.gov Identifier: NCT04662684    
Other Study ID Numbers: 21589 Michelle Trial
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Red Cap open file

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eduardo Ramacciotti, Science Valley Research Institute:
Covid19
Venous Thromboembolism
Direct oral anticoagulants
Rivaroxaban
Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
 Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants