NCT04508023

A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic Coronavirus Disease 2019 (COVID-19) Infection

A Multicenter, Randomized, Placebo-Controlled, Pragmatic Phase 3 Study Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic COVID-19 Infection

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,284 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether rivaroxaban reduces the risk of a composite endpoint of major venous and arterial thrombotic events, all-cause hospitalization, and all-cause mortality compared with placebo in outpatients with acute, symptomatic Coronavirus Disease 2019 (COVID-19) Infection.

Conditions

• Coronavirus Disease 2019 (COVID-19)

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Participants will receive rivaroxaban 10 mg tablet orally once daily.
OTHER	Placebo	Participants will receive matching placebo tablet orally once daily.
OTHER	Standard of Care (SOC)	SOC treatment will be determined by the investigator based on local practice and consists of supportive care.

Timeline

• Start date: 2020-08-13
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2020-08-11
• Last updated: 2023-07-18
• Results posted: 2023-07-18

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study