COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04401293

Alex C Spyropoulos, MD

Damian N Inlall, dinlall@northwell.edu (PI email not reported)

2020-05-26

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. understands and agrees to comply with planned study procedures. male or non-pregnant female adult ≥18 years of age at time of enrollment. subject consents to randomization within 72 hours of hospital admission or transfer from another facility within 72 hours of index presentation. subjects with a positive covid-19 diagnosis by nasal swab or serologic testing. hospitalized with a requirement for supplemental oxygen. have: either a d- dimer > 4.0 x uln, or sepsis-induced coagulopathy (sic) score of ≥4

indications for therapeutic anticoagulation absolute contraindication to anticoagulation including: active bleeding, recent (within 1 month) history of bleed, dual (but not single) antiplatelet therapy, active gastrointestinal and intracranial cancer, a history of bronchiectasis or pulmonary cavitation, hepatic failure with a baseline inr > 1.5, crcl < 15ml/min, a platelet count < 25,000, a history of heparin-induced thrombocytopenia (hit) within the past 100 days or in the presence of circulating antibodies, contraindications to enoxaparin including a hypersensitivity to enoxaparin sodium, hypersensitivity to heparin or pork products, hypersensitivity to benzyl alcohol, pregnant female, inability to give or designate to give informed consent, participation in another blinded trial of investigational drug therapy for covid-19

2

Northwell Health

18

100

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

257

Composite outcome of arterial thromboembolic events, venous thromboembolic events and all-cause mortality at Day 30 ± 2 days.

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"}]