COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04406389

Maria T DeSancho, MD, MSc

mtd2002@med.cornell.edu

2020-05-28

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - age >18 years old - covid-19 positive on (rt-pcr) nasopharyngeal swab, or suspected covid-19 infection with detectable sars-cov-2 igg or igm. - intensive care unit (icu) patient or non-icu patient on invasive mechanical ventilation, bipap, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula. - d dimer level greater than 700 ng/ml (3 times the upper limit of normal).

- objectively documented deep vein thrombosis or pulmonary embolism - patients in whom there is very high suspicion for pulmonary embolism and are on full-dose anticoagulation as per the treating physician - platelets <30,000 not due to disseminated intravascular coagulation (dic), based on the international society of thrombosis and haemostasis (isth) criteria and american society of hematology (ash) frequently asked questions - active bleeding that poses a contraindication to therapeutic anticoagulation in the opinion of the investigator. - history of bleeding diathesis (e.g., hemophilia, severe von willebrand disease, severe thrombocytopathy) - history of intracranial hemorrhage in the last 90 days - history of ischemic stroke in the past 2 weeks - major neurosurgical procedure in the past 30 days - cardiothoracic surgery in the past 30 days - intra-abdominal surgery in the past 30 days - intracranial malignancy - patients who require therapeutic anticoagulation for other reasons like atrial fibrillation, deep venous thrombosis, pulmonary embolism, or antiphospholipid syndrome.

2

Weill Medical College of Cornell University

18

100

United States

Critical disease at enrollment

8: Critical disease at enrollment

186

30-day mortality

None

Phase 4

[{"arm_notes": "", "treatment_id": 1337, "treatment_name": "Unfractioned heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1337, "treatment_name": "Unfractioned heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]