Randomized Study of Rivaroxaban vs Placebo on Disease Progression and Symptoms Resolution in High-Risk Adults With Mild Coronavirus Disease 2019.
| Autor: | Ananworanich, Jintanat, Mogg, Robin, Dunne, Michael W, Bassyouni, Mohamed, David, Consuela Vera, Gonzalez, Erika, Rogalski-Salter, Taryn, Shih, Heather, Silverman, Jared, Medema, Jeroen, Heaton, Penny |
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| Předmět: |
DISEASE progression
COVID-19 CONFIDENCE intervals ORAL drug administration AGE distribution ANTIVIRAL agents SEVERITY of illness index RIVAROXABAN PLACEBOS TREATMENT effectiveness RANDOMIZED controlled trials DESCRIPTIVE statistics BODY mass index STATISTICAL sampling DISEASE remission COMORBIDITY EVALUATION ADULTS |
| Zdroj: | Clinical Infectious Diseases; Jul2022, Vol. 75 Issue 1, pe473-e481, 9p |
| Abstrakt: | 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 <65 years; 60% female; 27% Hispanic, Black, or other minorities; and 69% with ≥2 comorbidities. Rivaroxaban was well tolerated. Disease progression rates were 46 of 222 (20.7%) in rivaroxaban vs 44 of 222 (19.8%) in placebo groups, with a risk difference of –1.0 (95% confidence interval, −6.4 to 8.4; P = .78). 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. [ABSTRACT FROM AUTHOR] |
| Databáze: | Complementary Index |
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