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

• Status: Completed
• Trial end date: 2021-05-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brazilian Clinical Research Institute
• Collaborators: Beneficência Portuguesa de São Paulo; Brazilian Research In Intensive Care Network; Hospital Alemão Oswaldo Cruz; Hospital do Coracao; Hospital Israelita Albert Einstein; Hospital Moinhos de Vento; Hospital Sirio-Libanes
• Treatments: Calcium heparin; Enoxaparin; Enoxaparin sodium; Heparin; Rivaroxaban

Criteria

Inclusion Criteria:

• Patients with confirmed diagnosis of COVID-19 admitted to hospital;

• Duration of symptoms related to hospitalization ≤ 14 days;

• Patients ≥ 18 year old;

• D-dimer above the upper limit of normal (collected until 72 hours before the randomization);

• Agreement to participate by providing the informed consent form (ICF).

Exclusion Criteria:

• Patients with indication for full anticoagulation during inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis);

• Platelets < 50,000 /mm3

• Need for ASA therapy > 100 mg;

• Need for P2Y12 inhibitor therapy (clopidogrel, ticagrelor or prasugrel);

• Chronic use of non-hormonal anti-inflammatory drugs;

• Sustained uncontrolled systolic blood pressure (BP) of ≥180 mmHg or diastolic BP of ≥100 mmHg;

• INR > 1,5;

• Patients contraindicated to full anticoagulation (active bleeding, liver failure, blood dyscrasia or prohibitive hemorrhage risk as evaluated by the investigator);

• Criteria for disseminated intravascular coagulation (DIC);

• A history of hemorrhagic stroke or any intracranial bleeding at any time in the past or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (AV) malformation, or aneurysm;

• Active cancer (excluding non-melanoma skin cancer) defined as cancer not in remission or requiring active chemotherapy or adjunctive therapies such as immunotherapy or radiotherapy;

• Hypersensitivity to rivaroxaban;

• Use of strong inhibitors of cytochrome P450 (CYP) 3A4 and/or P-glycoprotein (P-gp) (e.g. protease inhibitors, ketoconazole, Itraconazole) and/or use of P-gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort);

• Known HIV infection;

• Creatinine clearance < 30 ml/min according to the Cockcroft-Gault Formula;

• Pregnancy or breastfeeding.