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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04504032

Run by

Gates Medical Research Institute

People needed

497

Starts

2020-09-02

Expected to finish

2021-03-29

Last updated by the study team

2021-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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