COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04492254

Ajay Kakkar

Not reported

2020-07-30

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - signed informed consent - confirmed covid-19 (i.e. symptoms + positive test for sars-cov-2) - male or female, age ≥ 55 years - at least two of the following additional risk factors: age ≥ 70 years body mass index > 25 kg/m2 chronic obstructive pulmonary disease (copd)* diabetes* cardiovascular disease* corticosteroid use *defined as any disease requiring medical intervention or treatment.

- contraindications to unfractionated heparin or lmwh - recent (<48 hours) or planned spinal or epidural anesthesia or puncture, pci or thrombolytic therapy within the preceding 24 hours - increased risk for bleeding complications - pregnant women - severe renal impairment (gfr < 30 ml/min) - receiving any antiplatelet therapy (with the exception of low dose (≤100mg) aspirin) or anticoagulant therapy (e.g. vka, doac) - patients participating in an interventional study that is outside the purview of tri sponsored studies.

2

Thrombosis Research Institute

55

100

Australia;Belgium;South Africa

Mild disease at enrollment

1: Mild disease at enrollment

219

Death;Death;Death;Hospital Admission;Hospital Admission;Hospital Admission

None

Phase 3

[{"arm_notes": "", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]