NCT04394377

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

Randomized Clinical Trial to Evaluate a Routine Full Anticoagulation Strategy in Patients With Coronavirus (COVID-19) - COALIZAO ACTION Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 615 (actual)
• Sponsor: Brazilian Clinical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patients admitted to hospital with confirmed COVID-19, and who meet the eligibility criteria will be invited to participate in the proposed study. Following the application of the informed consent form, they will collect the D-dimer (if they have not yet collected it routinely from the hospital) and confirm the value over the normal limit in patients with confirmed COVID-19, will be randomized to 2 groups in the 1:1 ratio. Group 1 will follow the strategy of routine use of full anticoagulation therapy (oral or parenteral when indicated); and group 2 will follow the usual standard care with in-hospital prophylactic anticoagulation (without routine full anticoagulation).

Conditions

• Coronavirus Infection

Interventions

Type	Name	Description
DRUG	Group 1: Rivaroxaban 20mg/d followed by enoxaparin/unfractionated heparin when needed	Routine full anticoagulation strategy
DRUG	Group 2: control group with enoxaparin 40mg/d	Usual standard of care and currently have no indication of full anticoagulation.

Timeline

• Start date: 2020-06-21
• Primary completion: 2021-03-26
• Completion: 2021-05-30
• First posted: 2020-05-19
• Last updated: 2021-06-10

Locations

36 sites across 1 country: Brazil