Randomised controlled trial
Rivaroxaban for Prevention of Thrombotic Events, Hospitalization, and Death in Outpatients With COVID-19: A Randomized Clinical Trial
- Randomised controlled trial
- double-blind
- placebo-controlled
- virtual trial design
- 14 US integrated health care delivery networks
- terminated prematurely
- Terminated prematurely because of enrollment challenges and lower-than-expected blinded pooled event rate
- No patients lost to follow-up
Authors' conclusion
Rivaroxaban prescribed for 35 days in nonhospitalized patients with symptomatic COVID-19 at risk for thrombosis did not appear to reduce a composite end point of venous and arterial thrombotic events, hospitalization, and death.
Study context
- Population
- Nonhospitalized patients with symptomatic COVID-19 and ≥1 thrombosis risk factor
- Participants
- 1,284 patients
- Comparison
- Rivaroxaban 10 mg daily vs placebo for 35 days
- Rivaroxabann = 641
- Placebon = 643reference
- Primary endpoint
- Time to first symptomatic VTE, MI, ischemic stroke, acute limb ischemia, non-CNS systemic arterial embolism, hospitalization or death
- Follow-up
- Day 35
Primary result
As reported in the abstract
Hazard ratio
1.16
95% CI 0.63–2.15
P = 0.63
Events by treatment group
Rivaroxaban vs Placebo
HR 1.16 (95% CI 0.63–2.15); P = 0.63
Safety
events
| Outcome | Rivaroxaban | Placebo |
|---|---|---|
| ISTH critical-site or fatal bleeding (principal safety end point) | 0 | 0 |
| Major bleed | 1 | Not reported in the abstract |
Original publication
Rivaroxaban for Prevention of Thrombotic Events, Hospitalization, and Death in Outpatients With COVID-19: A Randomized Clinical Trial. Circulation. Published 8 May 2023. doi:10.1161/circulationaha.123.063901
Summarised from the published abstract; every number is checked against it