NCT04757857: CARE

COVID-19 Antithrombotic Rivaroxaban Evaluation

Terminated Phase 4 Last updated 25 January 2023

What this trial tests

Phase 4 trial testing Rivaroxaban 10 mg in COVID-19 in 660 participants. Terminated before completion.

Timeline

29 September 2020

Primary endpoint
8 August 2022

30 August 2022

Quick facts

Lead sponsor	Hospital Alemão Oswaldo Cruz
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	660
Start date	29 September 2020
Primary completion	8 August 2022
Estimated completion	30 August 2022
Sites	36 locations across Brazil

Drugs / interventions tested

• Rivaroxaban 10 mg — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Hospital Alemão Oswaldo Cruz

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There are several ways in which the COVID-19 pandemic may affect the prevention and management of thrombotic and thromboembolic disease, either direct effect or the indirect effects of infection, such as through severe illness and hypoxia, may predispose patients to thrombotic events. The severe inflammatory response, critical illness, and underlying traditional risk factors may all predispose to thrombotic events. Therefore, considering the high-risk profile of cardiovascular comorbidities in patients with COVID-19, it is scientifically relevant to evaluate the use of anticoagulants as an adjunctive treatment in the context of COVID-19. Indeed, it will be tested the hypothesis that the use of moderate dose of rivaroxaban has a beneficial effect in the treatment of patients with a confirmed or probable diagnosis of COVID-19 infection, with no clear indication for hospitalization (mild and moderate cases) upon initial medical care, by reducing the need of hospitalization due to complications related to COVID-19.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
   Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
2. Anticoagulants for people hospitalised with COVID-19: a rapid review
   Flumignan RL, Civile VT, Tinôco JDS, Pascoal PI, et al · · 2022 · cited 41× · PMID 35244208 · DOI 10.1002/14651858.cd013739.pub2
3. Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE - COALITION VIII randomised clinical trial.
   Avezum Á, Oliveira Junior HA, Neves PDMM, Alves LBO, et al · · 2023 · cited 13× · PMID 37223666 · DOI 10.1016/j.eclinm.2023.102004
4. Prophylactic anticoagulants for non-hospitalised people with COVID-19.
   Santos BC, Flumignan RL, Civile VT, Atallah ÁN, et al · · 2023 · cited 10× · PMID 37591523 · DOI 10.1002/14651858.cd015102.pub2
5. Understanding the immunological aspects of SARS-CoV-2 causing COVID-19 pandemic: A therapeutic approach.
   Das A, Roy S, Swarnakar S, Chatterjee N. · · 2021 · cited 6× · PMID 34303849 · DOI 10.1016/j.clim.2021.108804
6. Rivaroxaban in Outpatients with Mild or Moderate COVID-19: Rationale and Design of the Study CARE (CARE - Coalition COVID-19 Brazil VIII).
   Oliveira GBF, Neves PDMM, Oliveira HA, Catarino DGM, et al · · 2023 · cited 1× · PMID 37018790 · DOI 10.36660/abc.20220431
7. Rivaroxaban to Prevent Major Clinical Outcomes in Non-Hospitalised Patients with COVID-19: The Care – Coalition VIII Randomised Clinical Trial
   Avezum A, Junior HAO, Neves PDMdM, Alves LBO, et al · · 2023 · DOI 10.2139/ssrn.4344631