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Anticoagulant

Rivaroxaban for COVID-19 (PREVENT-HD Trial)

Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 35 (+/- 6 days)
Awards & highlights

PREVENT-HD Trial Summary

This study is evaluating whether a drug may help reduce the risk of blood clots in patients with a common virus.

Eligible Conditions
  • COVID-19

PREVENT-HD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 35 (+/- 6 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 35 (+/- 6 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint
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
Secondary outcome measures
Number of Participants Who Were Hospitalized or Dead on Day 35
Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria
Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes

Side effects data

From 2020 Phase 3 trial • 179 Patients • NCT02164578
2%
Hypertensive crisis
1%
Intervertebral disc protrusion
1%
Erysipelas
1%
Bile duct stone
1%
Diverticulitis
1%
Foot fracture
1%
Chest pain
1%
Nausea
1%
Vomiting
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aspirin
Rivaroxaban

PREVENT-HD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RivaroxabanExperimental Treatment2 Interventions
Participants will receive rivaroxaban 10 milligram (mg) tablet orally once daily for 35 Days along with standard of care treatment (SOC).
Group II: PlaceboPlacebo Group2 Interventions
Participants will receive matching placebo tablet orally once daily for 35 Days along with SOC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban
2015
Completed Phase 4
~157350

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,024 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,958,621 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04508023.
~275 spots leftby Apr 2025
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