Evidence map›Paper›PMID 34523673›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

Randomized Study of Rivaroxaban vs Placebo on Disease Progression and Symptoms Resolution in High-Risk Adults With Mild Coronavirus Disease 2019.

Jintanat Ananworanich, Robin Mogg, Michael W Dunne, Mohamed Bassyouni, Consuela Vera David, Erika Gonzalez, Taryn Rogalski-Salter, Heather Shih, Jared Silverman, Jeroen Medema and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 9 pooled it
3.1field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 9 syntheses or guidelines pooled it, 51 citations in OpenAlex.

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  7. Prophylactic anticoagulants for non-hospitalised people with COVID-19.The Cochrane database of systematic reviews · 2023
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  18. Rivaroxaban Plasma Concentration and Clinical Outcomes on Older Patients with Non-valvular Atrial Fibrillation and Pulmonary Infection.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Jintanat AnanworanichDepartment of Clinical Development, Bill & Melinda Gates Medical Research Institute, Cambridge, Massachusetts, USA.
Robin MoggDepartment of Clinical Development, Bill & Melinda Gates Medical Research Institute, Cambridge, Massachusetts, USA.
Michael W DunneDepartment of Clinical Development, Bill & Melinda Gates Medical Research Institute, Cambridge, Massachusetts, USA.
Mohamed BassyouniDepartment of Clinical Development, Bill & Melinda Gates Medical Research Institute, Cambridge, Massachusetts, USA.
Consuela Vera DavidDepartment of Allergy, Asthma and Clinical Research, Science 37, Los Angeles, California, USA.
Erika GonzalezDepartment of Medical Affairs, South Texas Allergy & Asthma Medical Professionals, San Antonio, Texas, USA.
Taryn Rogalski-SalterDepartment of Clinical Development, Bill & Melinda Gates Medical Research Institute, Cambridge, Massachusetts, USA.
Heather ShihDepartment of Clinical Development, Bill & Melinda Gates Medical Research Institute, Cambridge, Massachusetts, USA.
Jared SilvermanDepartment of Clinical Development, Bill & Melinda Gates Medical Research Institute, Cambridge, Massachusetts, USA.
Jeroen MedemaDepartment of Clinical Development, Bill & Melinda Gates Medical Research Institute, Cambridge, Massachusetts, USA.
Penny HeatonDepartment of Clinical Development, Bill & Melinda Gates Medical Research Institute, Cambridge, Massachusetts, USA.
Bill & Melinda Gates Foundation · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSevere 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.

methodsAdults (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.

resultsThe 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).

conclusionsWe 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.

Indexed as

COVID-19 Drug TreatmentAdultDisease ProgressionDouble-Blind MethodFemaleHumansMaleRivaroxabanSARS-CoV-2Treatment OutcomeRivaroxabanCOVID-19infectionpneumoniarivaroxabanSARS-CoV-2

Identifiers

PMID34523673
PMCPMC8522357
OpenAlexW3200339764

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.