1. Randomized Study of Rivaroxaban vs Placebo on Disease Progression and Symptoms Resolution in High-Risk Adults With Mild Coronavirus Disease 2019
- Author
-
Robin Mogg, Jintanat Ananworanich, Michael W. Dunne, Consuela Vera David, Heather Shih, Taryn Rogalski-Salter, Erika Gonzalez, Penny M. Heaton, Jeroen Medema, Mohamed Bassyouni, and Jared Silverman
- Subjects
Microbiology (medical) ,Adult ,Male ,medicine.medical_specialty ,Population ,coronavirus ,Placebo ,Double-Blind Method ,Rivaroxaban ,Internal medicine ,medicine ,Major Article ,Humans ,pneumonia ,education ,COVID ,education.field_of_study ,Intention-to-treat analysis ,business.industry ,SARS-CoV-2 ,Absolute risk reduction ,COVID-19 ,medicine.disease ,Interim analysis ,Comorbidity ,infection ,COVID-19 Drug Treatment ,Infectious Diseases ,Treatment Outcome ,AcademicSubjects/MED00290 ,Disease Progression ,Female ,business ,Progressive disease ,medicine.drug - Abstract
Background Severe acute respiratory syndrome coronavirus 2 infection may be associated with a prothrombotic state, predisposing patients for a progressive disease course. We investigated whether rivaroxaban, a direct oral anticoagulant factor Xa inhibitor, would reduce coronavirus disease 2019 (COVID-19) progression. Methods Adults (N = 497) with mild COVID-19 symptoms and at high risk for COVID-19 progression based on age, body mass index, or comorbidity were randomized 1:1 to either daily oral rivaroxaban 10 mg (N = 246) or placebo equivalent (N = 251) for 21 days and followed to day 35. Primary end points were safety and progression. Absolute difference in progression risk was assessed using a stratified Miettinen and Nurminen method. Results The study was terminated after 497 of the target 600 participants were enrolled due to a prespecified interim analysis of the first 200 participants that crossed the futility boundary for the primary efficacy end point in the intent-to-treat population. Enrollees were 85% aged Conclusions We did not demonstrate an impact of rivaroxaban on disease progression in high-risk adults with mild COVID-19. There remains a critical public health gap in identifying scalable effective therapies for high-risk people in the outpatient setting to prevent COVID-19 progression.
- Published
- 2021