Status:
UNKNOWN
Safety and Efficacy of Therapeutic Anticoagulation on Clinical Outcomes in Hospitalized Patients With COVID-19
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Cardiovascular Diseases
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The coronavirus disease 2019 (COVID-19) global pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused considerable morbidity and mortality in over 170 countries...
Detailed Description
Patients identified as eligible through discussions with the primary care team and review of the electronic medical record will be approached and consented as described above in "Subject Enrollment" a...
Eligibility Criteria
Inclusion
- Inclusion:
- COVID-19 positive on admission or during hospitalization (having been tested within the past 5 days) with symptoms consistent with COVID-19 including fever (≥ 38C, 100.4F), pneumonia, symptoms of lower respiratory illness (e.g., cough, difficulty breathing), loss of smell or taste, myalgias, pharyngitis, or diarrhea
- Admitted to the regular medical floor or intensive care unit (ICU) without severe ARDS (P/F ratio\<100)
- Elevated D-dimer (\>1.5g/mL)
- Age\>18 years and not older than 90
- Fibrinogen \>100
- Platelets \>50,000
- No prior intracranial hemorrhage or recent ischemic stroke or TIA within 6 months
- D-dimer \> 1500 ng/ml
- No other clinical indication for therapeutic anticoagulation (e.g., deep vein thrombosis \[DVT\], pulmonary embolism \[PE\], atrial fibrillation, acute coronary syndromes, or extracorporeal membrane oxygenation)
- Exclusion:
- Disseminated intravascular coagulation (DIC) according to the International Society on Thrombosis and Hemostasis overt DIC definition
- Hemoglobin (Hgb) \<8 g/dl
- Hypersensitivity to heparin or heparin formulation including heparin-induced thrombocytopenia
- Thrombocytopenia: platelets\<50,000 platelets/ul
- Uncontrolled or active/recent bleeding including intracranial hemorrhage, signs of active bleeding (e.g., blood transfusion within 30 days), any GI bleed within the past 6 months, or internal bleeding within the past 1 month
- High bleeding risk: significant closed-head or facial trauma within 3 months, traumatic or prolonged CPR (\>10min), or use of dual anti-platelet therapy
- Known or suspected pregnancy
- Recent (\<48 hours) or planned spinal or epidural anesthesia or puncture
- If the patient is on other anticoagulants, antihistamines, nonsteroidal anti-inflammatory drugs (i.e. aspirin) or hydroxychloroquine
- Uncontrolled hypertension
Exclusion
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04377997
Start Date
May 15 2020
End Date
June 1 2022
Last Update
February 22 2022
Active Locations (1)
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1
Abdurahman Khalil
Boston, Massachusetts, United States, 02114