COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04367831

Sahil Parikh, MD

sap2196@cumc.columbia.edu

2020-04-29

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - confirmed diagnosis of covid-19 by reverse transcription polymerase chain reaction (rt-pcr) - new admission to eligible cuimc icus within 5 days - transfer from nonparticipating to participating icu is eligible if otherwise meets eligibility criteria. - patients transferred between participating icus will maintain initial treatment assignment. - patients not on therapeutic anticoagulation and who were already admitted to participating icu within 5 days of trial initiation are additionally eligible.

- weight under 50kg - contraindication to anticoagulation in the opinion of the treating clinician including - overt bleeding - platelet count <50,000 - bleeding academic research consortium (barc) major bleeding in the past 30 days - gastrointestinal (gi) bleeding within 3 months - history of intracranial hemorrhage - ischemic stroke within the past 2 weeks - craniotomy/major neurosurgery within the past 30 days - cardiothoracic surgery within the past 30 days - intra-abdominal surgery within 30 days prior to enrollment - head or spinal trauma in the last months - history of uncorrected cerebral aneurysm or arteriovenous malformation (avm) - intracranial malignancy - presence of an epidural or spinal catheter - recent major surgery within the last 14 days - decrease in hemoglobin >3 g/dl over the last 24 hours - allergic reaction to anticoagulants (e.g. heparin induced thrombocytopenia) as documented in the electronic health records. extracorporeal membrane oxygenation (ecmo) support or other mechanical circulatory support. - severe chronic liver dysfunction (history of portosystemic hypertension (htn), esophageal varices, or child-pugh class c or above or similar model for end-stage liver disease (meld) scores), abnormality in liver function tests (aspartate aminotransferase (ast), alanine aminotransferase (alt), bilirubin) 5 times greater than upper normal limit. - a history of congenital bleeding diatheses or anatomical anomaly that predisposes to hemorrhage (e.g. hemophilia, hereditary hemorrhagic telangiectasia) - treating physician preference for therapeutic anticoagulation - enrollment in other concurrent trials related to anticoagulant or antiplatelet therapy - existing treatment with therapeutic anticoagulation during the previous 7 days of hospitalization prior to icu admission (e.g. for venous thromboembolism (vte), atrial fibrillation, mechanical valve, etc). - do-not-resuscitate (dnr) /do-not-intubate (dni) or comfort measures only (cmo) orders prior to randomization.

2

Columbia University

18

80

United States

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

94

Total Number of Patients with Clinically Relevant Venous or Arterial Thrombotic Events in ICU

None

Phase 4

[{"arm_notes": "Enoxaparin Dose 1: 1mg/kg; administration route: SC; treatment frequency: OD\nHeparin Dose 1: 10units/kg/hour; administration route: infusion", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Enoxaparin Dose 2: BMI < 40 kg/m2: 40 mg SC daily, BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h, BMI > 50 kg/m2: Enoxaparin 60 mg SC q12h; \nHeparin Dose 2: 5000-7500 units; Heparin Administration route: SC; Heparin Treatment frequency:every 8 hours", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]