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A Trial to Evaluate Safety and Efficacy of Rivaroxaban (COVID-19)

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ClinicalTrials.gov Identifier: NCT04504032
Recruitment Status : Terminated (Based on Data Monitoring Committee's recommendation on February 3, 2021, the study was stopped due to futility.)
First Posted : August 7, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Bill & Melinda Gates Medical Research Institute

Brief Summary:
The purpose of this study is to assess safety and clinical efficacy of rivaroxaban in people with mild Coronavirus Disease 2019 who are at increased risk of disease progression.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Rivaroxaban Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 497 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Phase 2b Study to Evaluate Safety and Efficacy of Rivaroxaban (Xarelto®) for High Risk People With Mild COVID-19
Actual Study Start Date : September 2, 2020
Actual Primary Completion Date : March 10, 2021
Actual Study Completion Date : March 29, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Rivaroxaban Drug: Rivaroxaban
Participants will receive Rivaroxaban 10 milligram (mg) tablet by mouth, once daily for 21 days

Placebo Comparator: Placebo Drug: Placebo
Participants will receive placebo (multi-vitamin supplement) tablet by mouth, once daily for 21 days




Primary Outcome Measures :
  1. Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) [ Time Frame: Up to approximately 35 days ]
  2. Number of Participants With AEs Leading to Study Discontinuation [ Time Frame: Up to approximately 35 days ]
  3. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 35 days ]
  4. Proportion of Participants With Disease Progression [ Time Frame: Up to Day 28 ]
    Disease progression is defined as the proportion of participants who progress to moderate or severe disease category or higher (Gates Medical Research Institute ordinal scale ≥3). The assessments will be performed using Gates Medical Research Institute ordinal scale.


Secondary Outcome Measures :
  1. Median Time to Disease Resolution [ Time Frame: Up to Day 28 ]
    Time to disease resolution is defined as symptoms resolution (new onset Coronavirus Disease 2019 [COVID-19] symptoms resolved, and pre-existing symptoms returned to baseline) with viral clearance (two consecutive negative diagnostic tests) through Day 28. Baseline refers to health status prior to contracting new onset COVID-19 symptoms.

  2. Median Time to Disease Resolution [ Time Frame: Up to Day 28 ]
    Time to disease resolution is defined as symptoms resolution only (new onset COVID-19 symptoms resolved, and preexisting symptoms returned to baseline) through Day 28. Baseline refers to health status prior to contracting new onset COVID-19 symptoms.

  3. Proportion of Participants With Disease Progression [ Time Frame: Days 8, 14, and 21 ]
  4. Proportion of Participants Who Achieve Disease Resolution [ Time Frame: Days 8, 14, 21, and 28 ]
  5. Mean Gates Medical Research Institute Ordinal Scale Score [ Time Frame: Days 8, 14, 21, and 28 ]
  6. Change From Baseline in Gates Medical Research Institute Ordinal Scale Score [ Time Frame: Days 8, 14, 21, and 28 ]
  7. Mean World Health Organization Ordinal Scale Score [ Time Frame: Days 8, 14, 21, and 28 ]
  8. Change From Baseline in World Health Organization Ordinal Scale Score [ Time Frame: Days 8, 14, 21, and 28 ]
  9. Incidence of Hospitalization [ Time Frame: Days 8, 14, 21, and 28 ]
  10. Number of Days of Hospitalization [ Time Frame: Days 8, 14, 21, and 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be at high-risk for Coronavirus disease 2019 (COVID-19) disease progression by fulfilling at least one of the following criteria at screening:

    • Presence of chronic pulmonary disease, chronic obstructive pulmonary disease (COPD), pulmonary hypertension
    • Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for treatment
    • Hypertension, requiring at least one oral medication for treatment
    • Immunocompromised status due to disease (e.g., those living with human immunodeficiency virus with a cluster of differentiation 4 [CD4] T-cell count of <200 per cubic millimeter [mm^3])
    • Immunocompromised status due to medication (e.g., taking 20 milligram [mg] or more of prednisone equivalents a day, anti-inflammatory monoclonal antibody therapies, cancer therapies)
    • Any chronic disease that is associated with high risk for severe COVID in the opinion of the site investigator
    • Body mass index ≥35 Kilogram per square meter (kg/m^2) (based on self-reported weight and height).
  • Documented Severe Acute Respiratory Syndrome Coronavirus 2 positive diagnostic test of ≤7 days at the time of screening
  • Symptomatic for COVID-19 for ≤72 hours at the time of screening (defined as having at least 2 of the following symptoms of COVID-19 that is of new onset or has worsened from baseline, and include fever, chills, myalgia, arthralgia, headache, fatigue, cough, sore throat, nasal congestion, anosmia, ageusia, nausea, vomiting, or diarrhea. If only two symptoms are present, they cannot both be anosmia and ageusia)
  • Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the inform consent form and in this protocol
  • Agree to participate in all remote, in-person or home visits as required in the protocol and provide updated contact information as necessary.
  • Female of childbearing potential must agree to practice adequate contraception during the study

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Currently hospitalized or under immediate consideration for hospitalization at screening and Day 1
  • Have new onset shortness of breath or increased shortness of breath from pre-COVID-19 (for people with known COPD) at screening and Day 1
  • Hypoxemia (oxygen saturation <94% in ambient air or oxygen saturation below pre-COVID-19 level for people with known COPD) at Day 1
  • Require supplemental oxygen (new requirement or increase in requirement from pre-COVID-19 condition) at screening and Day 1
  • Have a history of (in the past 3 months) or current active pathological bleeding
  • Have a history of hemorrhagic stroke or intracranial hemorrhage
  • Have a recent severe head trauma within 30 days which includes concussion, skull fracture or hospitalization for head injury
  • Have known intracranial neoplasm, cerebral metastases, arteriovenous malformation or aneurysm
  • Have history of pregnancy-related hemorrhage
  • Have active gastroduodenal ulcer or other gastrointestinal bleeding diagnosed in the past 3 months
  • Currently are in a hemodynamically unstable state
  • Currently require thrombolysis or pulmonary embolectomy
  • Have history of severe hypersensitivity reaction to Xarelto®
  • Currently have a prosthetic heart valve
  • Have known diagnosis of triple positive antiphospholipid syndrome
  • Have known diagnosis of chronic kidney disease (stage IV or receiving dialysis)
  • Have a history of thrombocytopenia or known platelet count <100,000 cells/mm^3
  • Have history of bronchiectasis and pulmonary cavitation
  • Have active cancer (e.g, receiving chemotherapy or treatment for complication of the active cancer)
  • Had epidural or neuraxial anesthesia or spinal puncture in the past 2 weeks and plan to undergo these procedures during the study
  • Had surgery in the past 4 weeks or plan to undergo surgery during the study
  • Currently is pregnant or plans to become pregnant
  • Currently is breastfeeding
  • Share household with an enrolled participant in this study
  • Co-enrollment in any clinical trial that includes prohibited procedures (spinal puncture or surgery) or that includes treatments within the same drug class as rivaroxaban or treatments for which co-administration with rivaroxaban are prohibited. Note that any co-enrollment other than this requires approval by the Sponsor. For any coenrolled study, the total volume of blood samples collected across the studies should not exceed 275 milliliters (mL) in 4 weeks.
  • Currently using and plan to use the following medications during the study

    • Rivaroxaban or drugs in the same class
    • Dual anti-platelets therapy
    • Other anticoagulants
    • Combined Permeability glycoprotein (P-gp) and cytochrome CYP3A inhibitors and inducers

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): NCT04504032


Locations
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Sponsors and Collaborators
Bill & Melinda Gates Medical Research Institute
Investigators
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Study Director: GatesMRI Bill & Melinda Gates Medical Research Institute
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Responsible Party: Bill & Melinda Gates Medical Research Institute
ClinicalTrials.gov Identifier: NCT04504032    
Other Study ID Numbers: Gates MRI - COD-01-T01-01
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bill & Melinda Gates Medical Research Institute:
Rivaroxaban
Xarelto
Coronavirus
COVID-19
Coronavirus disease 2019
Additional relevant MeSH terms:
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Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants