Status:
COMPLETED
Full Anticoagulation Versus Prophylaxis in COVID-19: COALIZAO ACTION Trial
Lead Sponsor:
Brazilian Clinical Research Institute
Collaborating Sponsors:
Hospital Israelita Albert Einstein
Hospital do Coracao
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 anticoagulatio...
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 for...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2021
Estimated Enrollment :
615 Patients enrolled
Trial Details
Trial ID
NCT04394377
Start Date
June 21 2020
End Date
May 30 2021
Last Update
June 10 2021
Active Locations (36)
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1
Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará, Brazil
2
Centro de Ensino e Aperfeiçoamento em Pesquisa - CEAP
Serra, Espírito Santo, Brazil
3
Centro de Estudos Clínicos do Hospital Cárdio Pulmonar
Salvador, Estado de Bahia, Brazil
4
Instituto de Ensino e Pesquisa do Hospital da Bahia
Salvador, Estado de Bahia, Brazil