Trial · 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
NCT04508023, Phase 3, Terminated, Janssen Research & Development, LLC; results first posted 2023-07-18
3 sourcestrials-2026-11-12-0.5.0
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Cite this record
ConductScience Library. 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. Trials, record NCT04508023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04508023
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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 number
- NCT04508023
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,284 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Interventions
- Rivaroxaban, Placebo, Standard of Care (SOC)
- First posted
- 2020-08-11
- Last updated
- 2023-07-18
- Results first posted
- 2023-07-18
- Limitations and caveats
- The study was terminated prematurely due to enrollment challenges.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint | Up to Day 35 | 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. |
| Primary | 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 | Up to Day 35 | 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. |
| Secondary | Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes | From Day 1 up to Day 35 | 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. |
| Secondary | Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria | Up to Day 35 | 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. |
| Secondary | Number of Participants Who Were Hospitalized or Dead on Day 35 | At Day 35 (+/- 6 days) | Number of participants who were hospitalized or dead on Day 35 were reported. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint | Up to Day 35 | Intent-To-Treat (ITT) analysis set included all randomized participants who provided informed consent. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 | Up to Day 35 | The safety analysis set included participants in ITT who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes | From Day 1 up to Day 35 | ITT analysis set included all randomized participants who provided informed consent. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria | Up to Day 35 | The safety analysis set included participants in ITT who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Were Hospitalized or Dead on Day 35 | At Day 35 (+/- 6 days) | ITT analysis set included all randomized participants who provided informed consent. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint | Rivaroxaban 10 Milligrams (mg) | 22 | Participants | ||
| Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint | Placebo | 19 | 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 | Rivaroxaban 10 Milligrams (mg) | Fatal Bleeding | 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 | Placebo | Fatal Bleeding | 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 | Rivaroxaban 10 Milligrams (mg) | Critical Site Bleeding | 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 | Placebo | Critical Site Bleeding | 0 | Participants | |
| Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes | Rivaroxaban 10 Milligrams (mg) | Symptomatic VTE | 0 | Participants | |
| Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes | Placebo | Symptomatic VTE | 3 | Participants | |
| Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes | Rivaroxaban 10 Milligrams (mg) | Myocardial Infraction | 0 | Participants | |
| Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes | Placebo | Myocardial Infraction | 0 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rivaroxaban 10 Milligrams (mg) | 641 | |
| Overall Study | STARTED | Placebo | 643 | |
| Overall Study | Treated (Safety Analysis Set) | Rivaroxaban 10 Milligrams (mg) | 599 | |
| Overall Study | Treated (Safety Analysis Set) | Placebo | 598 | |
| Overall Study | COMPLETED | Rivaroxaban 10 Milligrams (mg) | 640 | |
| Overall Study | COMPLETED | Placebo | 641 | |
| Overall Study | NOT COMPLETED | Rivaroxaban 10 Milligrams (mg) | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events166
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Angina Pectoris | Cardiac disorders | Rivaroxaban 10 Milligrams (mg) | 0 | 599 | |
| other | Angina Pectoris | Cardiac disorders | Placebo | 1 | 598 | |
| other | Palpitations | Cardiac disorders | Rivaroxaban 10 Milligrams (mg) | 0 | 599 | |
| other | Palpitations | Cardiac disorders | Placebo | 2 | 598 | |
| other | Ear Pain | Ear and labyrinth disorders | Rivaroxaban 10 Milligrams (mg) | 0 | 599 | |
| other | Ear Pain | Ear and labyrinth disorders | Placebo | 1 | 598 | |
| other | Vertigo | Ear and labyrinth disorders | Rivaroxaban 10 Milligrams (mg) | 1 | 599 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 598 | |
| other | Eye Pruritus | Eye disorders | Rivaroxaban 10 Milligrams (mg) | 0 | 599 | |
| other | Eye Pruritus | Eye disorders | Placebo | 1 | 598 |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban 10 Milligrams (mg) | 2 | 641 |
| Total, all-cause mortality | Placebo | 2 | 643 |
| Total, other adverse events | Rivaroxaban 10 Milligrams (mg) | 57 | 599 |
| Total, other adverse events | Placebo | 50 | 598 |
| Total, serious adverse events | Rivaroxaban 10 Milligrams (mg) | 1 | 599 |
| Total, serious adverse events | Placebo | 0 | 598 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rivaroxaban 10 Milligrams (mg) vs Placebo: Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint | Trial comparisons |
| Rivaroxaban 10 Milligrams (mg) vs Placebo: Number of Participants Who Were Hospitalized or Dead on Day 35 | Trial comparisons |
| Rivaroxaban 10 Milligrams (mg) vs Placebo: Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria | Trial comparisons |
| Rivaroxaban 10 Milligrams (mg) vs Placebo: deaths from any cause | Trial comparisons |
| Rivaroxaban 10 Milligrams (mg) vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04508023
GET https://conductscience.org/api/trials/v1/NCT04508023/results?page=2