A Trial to Evaluate Safety and Efficacy of Rivaroxaban (COVID-19)
NCT ID: NCT04504032
Last Updated: 2021-10-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
497 participants
INTERVENTIONAL
2020-09-02
2021-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Rivaroxaban
Rivaroxaban
Participants self-administered rivaroxaban, 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
Placebo
Placebo
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
Interventions
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Rivaroxaban
Participants self-administered rivaroxaban, 10 milligrams (mg) (1 tablet) orally once daily for 21 days.
Placebo
Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 co-enrolled 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 P450 3A (CYP3A) inhibitors and inducers
18 Years
ALL
No
Sponsors
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Gates Medical Research Institute
OTHER
Responsible Party
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Principal Investigators
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GatesMRI
Role: STUDY_DIRECTOR
Gates Medical Research Institute
Locations
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Woodland Research Northwest LLC - ERG - PPDS
Rogers, Arkansas, United States
Science 37, Inc
Los Angeles, California, United States
Allergy and Asthma Medical Group and Research Center - CRN - PPDS
San Diego, California, United States
Invesclinic, LLC
Fort Lauderdale, Florida, United States
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, United States
LCC Medical Research - Miami - BTC - PPDS
Miami, Florida, United States
Adult Medicine of Lake County
Mt. Dora, Florida, United States
Providea Health Partners LLC
Evergreen Park, Illinois, United States
Clinical Research Institute, Inc - CRN - PPDS
Minneapolis, Minnesota, United States
Encompass Care
North Las Vegas, Nevada, United States
Riverside Medical Group - Circuit- PPDS
Secaucus, New Jersey, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Harlem Hospital Center
New York, New York, United States
NYC Health + Hospitals/Lincoln
The Bronx, New York, United States
Premier Family Physicians - Austin - Hunt - PPDS
Austin, Texas, United States
Village Health Partners - Plano - Hunt - PPDS
Plano, Texas, United States
South Texas Allergy and Asthma Medical Professionals
San Antonio, Texas, United States
Boundary House Medical Centre
Sale, Cheshire, United Kingdom
St Mary's Hospital - PPDS
London, City of London, United Kingdom
Royal Free Hospital
London, , United Kingdom
Countries
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References
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Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.
Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-005395-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Gates MRI - COD-01-T01-01
Identifier Type: -
Identifier Source: org_study_id