Trial Outcomes & Findings for 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 (NCT NCT04508023)

Last Updated: 2023-07-18

Results Overview

Number of participants with time to first occurrence of primary efficacy composite endpoint were reported. Time to first occurrence of primary efficacy composite endpoint is defined as time from randomization to first occurrence of any component of the primary endpoint. The components were: symptomatic venous thromboembolism (VTE), myocardial infarction (MI), ischemic stroke, acute limb ischemia, non-central nervous system (non-CNS) systemic embolization, all-cause hospitalization, and all-cause mortality.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1284 participants

Primary outcome timeframe

Up to Day 35

Results posted on

2023-07-18

Participant Flow

Participants who were not treated with study drug were still followed-up as per the planned visits.

Participant milestones

Participant milestones
Measure	Rivaroxaban 10 Milligrams (mg) Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.	Placebo Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
Overall Study STARTED	641	643
Overall Study Treated (Safety Analysis Set)	599	598
Overall Study COMPLETED	640	641
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Rivaroxaban 10 Milligrams (mg) Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.	Placebo Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rivaroxaban 10 Milligrams (mg) n=641 Participants Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.	Placebo n=643 Participants Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.	Total n=1284 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 13.07 • n=93 Participants	55.7 years STANDARD_DEVIATION 13.3 • n=4 Participants	56 years STANDARD_DEVIATION 13.18 • n=27 Participants
Sex: Female, Male Female	399 Participants n=93 Participants	384 Participants n=4 Participants	783 Participants n=27 Participants
Sex: Female, Male Male	242 Participants n=93 Participants	259 Participants n=4 Participants	501 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	95 Participants n=93 Participants	97 Participants n=4 Participants	192 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	520 Participants n=93 Participants	508 Participants n=4 Participants	1028 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	26 Participants n=93 Participants	38 Participants n=4 Participants	64 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	5 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) Asian	25 Participants n=93 Participants	16 Participants n=4 Participants	41 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) Black or African American	61 Participants n=93 Participants	65 Participants n=4 Participants	126 Participants n=27 Participants
Race (NIH/OMB) White	465 Participants n=93 Participants	464 Participants n=4 Participants	929 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	85 Participants n=93 Participants	90 Participants n=4 Participants	175 Participants n=27 Participants
Region of Enrollment United States	641 Participants n=93 Participants	643 Participants n=4 Participants	1284 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to Day 35

Population: Intent-To-Treat (ITT) analysis set included all randomized participants who provided informed consent.

Outcome measures

Outcome measures
Measure	Rivaroxaban 10 Milligrams (mg) n=641 Participants Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.	Placebo n=643 Participants Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint	22 Participants	19 Participants

PRIMARY outcome

Timeframe: Up to Day 35

Population: The safety analysis set included participants in ITT who received at least 1 dose of study intervention.

Number of participants with time to first occurrence of the principle safety outcome (fatal bleeding and critical site bleeding) based on a Modification of the ISTH criteria were reported. Fatal bleeding is defined as any bleeding event that leads to fatal outcome. Critical site bleeding defined as any bleeding event that occurred at critical site such as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal.

Outcome measures

Outcome measures
Measure	Rivaroxaban 10 Milligrams (mg) n=599 Participants Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.	Placebo n=598 Participants Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
Number of Participants With Time to First Occurrence of The Principle Safety Outcome (Fatal Bleeding and Critical Site Bleeding) Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria Fatal Bleeding	0 Participants	0 Participants
Number of Participants With Time to First Occurrence of The Principle Safety Outcome (Fatal Bleeding and Critical Site Bleeding) Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria Critical Site Bleeding	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 up to Day 35

Population: ITT analysis set included all randomized participants who provided informed consent.

Number of participants with time to the first occurrence of secondary efficacy outcomes which included thrombotic events (symptomatic VTE, myocardial infarction, ischemic stroke, acute limb ischemia, non-CNS systemic embolization), emergency room (ER) visit, all-cause mortality, all-cause hospitalization, any thrombotic outcome and all-cause mortality, and any thrombotic outcome and all-cause hospitalization, were reported.

Outcome measures

Outcome measures
Measure	Rivaroxaban 10 Milligrams (mg) n=641 Participants Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.	Placebo n=643 Participants Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes Non-CNS systemic embolization	0 Participants	0 Participants
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes Symptomatic VTE	0 Participants	3 Participants
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes Myocardial Infraction	0 Participants	0 Participants
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes Ischemic stroke	0 Participants	2 Participants
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes Acute limb ischemia	0 Participants	0 Participants
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes ER Visit	26 Participants	34 Participants
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes All-cause hospitalization	21 Participants	17 Participants
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes All-cause Mortality	2 Participants	2 Participants
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes Any Thrombotic Outcome and All-cause Mortality	2 Participants	7 Participants
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes Any Thrombotic Outcome and All-cause Hospitalization	21 Participants	17 Participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: The safety analysis set included participants in ITT who received at least 1 dose of study intervention.

Number of participants with time to first occurrence of the major bleeding based on a modification of the ISTH criteria were reported. Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 grams per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome.

Outcome measures

Outcome measures
Measure	Rivaroxaban 10 Milligrams (mg) n=599 Participants Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.	Placebo n=598 Participants Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Day 35 (+/- 6 days)

Population: ITT analysis set included all randomized participants who provided informed consent.

Number of participants who were hospitalized or dead on Day 35 were reported.

Outcome measures

Outcome measures
Measure	Rivaroxaban 10 Milligrams (mg) n=641 Participants Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.	Placebo n=643 Participants Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
Number of Participants Who Were Hospitalized or Dead on Day 35	5 Participants	3 Participants

Adverse Events

Rivaroxaban 10 Milligrams (mg)

Serious events: 1 serious events

Other events: 57 other events

Deaths: 2 deaths

Placebo

Serious events: 0 serious events

Other events: 50 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Rivaroxaban 10 Milligrams (mg) n=599 participants at risk Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.	Placebo n=598 participants at risk Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician.
Immune system disorders Drug Hypersensitivity	0.17% 1/599 • Adverse Event collection started from screening up to Day 49 post-treatment follow-up All-cause mortality was analyzed based on intent-to-treat (ITT) set defined as all randomized participants who provided informed consent. Serious adverse events and other adverse events were analyzed based on the safety analysis set defined as all participants who received at least 1 dose of study intervention.	0.00% 0/598 • Adverse Event collection started from screening up to Day 49 post-treatment follow-up All-cause mortality was analyzed based on intent-to-treat (ITT) set defined as all randomized participants who provided informed consent. Serious adverse events and other adverse events were analyzed based on the safety analysis set defined as all participants who received at least 1 dose of study intervention.

Other adverse events

Additional Information

Senior Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER