FREEDOM COVID-19 Anticoagulation Strategy

Completed · Phase 4

Conditions studied: COVID-19, SARS-CoV-2

In brief

Coronavirus Disease (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has led to unprecedented morbidity and mortality in the modern era. To date, nearly 13 million people have contracted COVID-19, leading to more than 550,000 deaths worldwide. As the number of affected individuals continues to climb, effective strategies for treatment and prevention of the disease are of paramount importance. SARS-CoV-2 is understood to directly invade cells via the human angiotensin-converting enzyme 2 (ACE2) receptor, which is expressed predominantly in the lungs but also throughout the cardiovascular system. Thus, while acute respiratory distress syndrome remains a feared complication, new thromboembolic disease has emerged as a common and potentially catastrophic manifestation of COVID-19.

Key facts

Study ID

NCT04512079

Run by

Valentin Fuster

People needed

3460

Starts

2020-09-08

Expected to finish

2022-12-30

Last updated by the study team

2023-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hospitalization within the prior 24 hours for either confirmed (based on PCR or antigen positive test for SARS-CoV-2) or suspected COVID-19 based on 3 criteria (all 3 must be present for suspected cases):
• Fever >38 degrees Celsius
• O2 saturation ≤94
• Abnormal laboratory marker (at least 1):
• i. d-dimer ≥1.0 μg /mL ii. CRP >2 mg/L iii. Ferritin >300 μg /L iv. Lymphopenia <1500 cells /m3
• Patient or legal guardian provides written informed consent

You may not qualify if…

• Age <18 years
• Mechanical ventilation on admission or high likelihood for the need for invasive mechanical ventilation within 24 hours of admission
• Anticipated duration of hospital stay <72 hours
• Treatment with therapeutic dose UFH or LMWH, vitamin K antagonists, or NOACs within seven days
• Active bleeding
• Risk factors for bleeding, including:
• intracranial surgery or stroke within 3 months
• history of intracerebral arteriovenous malformation
• cerebral aneurysm or mass lesions of the central nervous system
• intracranial malignancy
• history of intracranial bleeding
• history of bleeding diatheses (e.g., hemophilia)
• history of gastrointestinal bleeding within previous 3 months
• thrombolysis within the previous 7 days
• presence of an epidural or spinal catheter
• recent major surgery <14 days
• uncontrolled hypertension (sBP > 200 mmHg or dBP > 120 mmHg)
• other physician-perceived contraindications to anticoagulation
• Platelet count <50 x109/L, INR >2.0, or baseline aPTT >50 seconds
• Hemoglobin <80 g/L (to minimize the likelihood of requiring red blood cell transfusion if potential bleeding were to occur)
• current treatment with antithrombotics or antiplatelet agents including but not limited to ticagrelor, prasugrel, and aspirin> 100mg, or non-steroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen, etc.) due to increased risk of bleeding, unless such agents can be permanently discontinued (aspirin <= 100mg and clopidogrel <=75mg is permitted)
• Acute or subacute bacterial endocarditis
• History of heparin induced thrombocytopenia (HIT) or other heparin allergy including hypersensitivity
• Patients with non-COVID-19 related clinical condition for which life expectancy is <6 months
• Pregnancy (women of childbearing potential are required to have a negative pregnancy test prior to enrollment)

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Instituto do Coração - INCOR — São Paulo, Brazil
• Instituto Prevent Senior - IPS — São Paulo, Brazil
• Clínica de la Costa — Barranquilla, Colombia
• Clínica Shaio — Bogotá, Colombia
• Fundación Cardioinfantil — Bogotá, Colombia
• Fundacion Oftalmológica de Santander - Foscal — Bucaramanga, Colombia
• Centro Médico Imbanaco — Cali, Colombia
• CardioVid — Medellín, Colombia
• Eternal Heart Care Centre and Research Ins Pvt Ltd. — Jaipur, India
• Jaipur National University — Jaipur, India
• Sawai Mann Singh Hospital — Jaipur, India
• Jaslok Hospital & Research Center — Mumbai, India
• Saifee Hospital — Mumbai, India
• Sengupta Hospital & Research Institute — Nagpur, India
• D Y Patil University School of Medicine & D Y Patil Hospital — Navi Mumbai, India
• Hospital Cardiológica Aguascalientes — Aguascalientes, Mexico
• Centro Médico Nacional 20 de Noviembre — Mexico City, Mexico
• Christus Muguerza Hospital Alta Especialidad — Monterrey, Mexico
• Centro de Estudios Clinicos de Querétaro S.C. — Querétaro City, Mexico
• Centro Medico Hospital del Prado — Tijuana, Mexico

Full record on ClinicalTrials.gov

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