NCT04394377: ACTION

Full Anticoagulation Versus Prophylaxis in COVID-19: COALIZAO ACTION Trial

Completed Phase 4 Last updated 10 June 2021

What this trial tests

Phase 4 trial testing Group 1: Rivaroxaban 20mg/d followed by enoxaparin/unfractionated heparin when needed in Coronavirus Infection in 615 participants. Completed in 30 May 2021.

Timeline

21 June 2020

Primary endpoint
26 March 2021

30 May 2021

Quick facts

Lead sponsor	Brazilian Clinical Research Institute
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	615
Start date	21 June 2020
Primary completion	26 March 2021
Estimated completion	30 May 2021
Sites	36 locations across Brazil

Drugs / interventions tested

• Group 1: Rivaroxaban 20mg/d followed by enoxaparin/unfractionated heparin when needed — full drug profile →
• Group 2: control group with enoxaparin 40mg/d — full drug profile →

Conditions studied

• Coronavirus Infection — all drugs for Coronavirus Infection →

Sponsor

Brazilian Clinical Research Institute

Who can join

18 and older, any sex, with Coronavirus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pragmatic randomized clinical trial of patients admitted to the hospital with confirmed COVID-19 infection and elevated D-Dimer.

Randomization 1:1 - Group 1 will undergo a routine full anticoagulation (oral or parenteral when needed) strategy; and group 2 will receive usual standard of care with prophylactic anticoagulation

Publications & conference data

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

1. Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial.
   Lopes RD, de Barros E Silva PGM, Furtado RHM, Macedo AVS, et al · · 2021 · cited 371× · PMID 34097856 · DOI 10.1016/s0140-6736(21)01203-4
2. Thrombosis in COVID-19.
   Hanff TC, Mohareb AM, Giri J, Cohen JB, et al · · 2020 · cited 232× · PMID 32857878 · DOI 10.1002/ajh.25982
3. COVID-19 and thrombosis: From bench to bedside.
   Ali MAM, Spinler SA. · · 2021 · cited 140× · PMID 33338635 · DOI 10.1016/j.tcm.2020.12.004
4. Recent Randomized Trials of Antithrombotic Therapy for Patients With COVID-19: JACC State-of-the-Art Review.
   Talasaz AH, Sadeghipour P, Kakavand H, Aghakouchakzadeh M, et al · · 2021 · cited 126× · PMID 33741176 · DOI 10.1016/j.jacc.2021.02.035
5. Coronavirus Disease 2019-Associated Thrombosis and Coagulopathy: Review of the Pathophysiological Characteristics and Implications for Antithrombotic Management.
   Ortega-Paz L, Capodanno D, Montalescot G, Angiolillo DJ. · · 2021 · cited 112× · PMID 33228447 · DOI 10.1161/jaha.120.019650
6. Cardiac involvement in the long-term implications of COVID-19.
   Satterfield BA, Bhatt DL, Gersh BJ. · · 2022 · cited 101× · PMID 34686843 · DOI 10.1038/s41569-021-00631-3
7. Anticoagulant interventions in hospitalized patients with COVID-19: A scoping review of randomized controlled trials and call for international collaboration.
   Tritschler T, Mathieu ME, Skeith L, Rodger M, et al · · 2020 · cited 77× · PMID 32888372 · DOI 10.1111/jth.15094
8. Small molecules in the treatment of COVID-19.
   Lei S, Chen X, Wu J, Duan X, et al · · 2022 · cited 74× · PMID 36464706 · DOI 10.1038/s41392-022-01249-8