COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04359277

Jeffrey Berger

jeffrey.berger@nyumc.org

2020-04-24

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: 1. >18 years of age 2. hospitalized patient with a diagnosis of covid-19 3. elevated d-dimer within prior 48 hours. definition of elevated d-dimer is site-determined

1. meeting alternative indication for higher-dose anticoagulation 1. prevalent blood clot at the time of enrollment 2. d-dimer >10,000 ng/ml 3. rapidly rising d-dimer (change in d-dimer >10x over the prior 48 hours) 4. prior vte 5. atrial fibrillation (with a chads2 score >1*) 2. renal failure (creatinine clearance <15 and/or requirement of renal replacement therapies) 3. heparin induced thrombocytopenia within 100 days 4. stroke within 30 days 5. hemorrhagic stroke (ever) 6. gi bleed within 6 months 7. platelet count <100,000 8. anemia with a hemoglobin <9mg/dl 9. pregnancy 10. signs of active bleeding (e.g. a whole blood or prbc transfusion in the past 30 days) 11. other high bleeding risk (i.e. trauma, use of dual antiplatelet therapy) 12. chf, hypertension, age>75 years, diabetes, prior stroke or tia symptoms

2

NYU Langone Health

18

None

United States

No restriction on type of patients

0: No restriction on type of patients

77

Composite incidence of: all-cause mortality, cardiac arrest, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, stroke, or shock

None

Phase 3

[{"arm_notes": "", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]