Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Enoxaparin 40mg in pre-filled syringe: Enoxaparin is intended for use as a single-dose subcutaneous injection and participants will either receive enoxaparin 40mg once daily or twice da
Sponsors
Thrombosis Research Institute
Ms Tech Observer India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female, age equal or greater than 55 years but no upper age limit At least two of the following additional risk factors: Age equal or greater than 70 years Body mass index > 25 kg/m2 Chronic obstructive pulmonary disease (COPD) Diabetes Cardiovascular disease Corticosteroid use
Exclusion criteria
Exclusion criteria: � Contraindications to unfractionated heparin or LMWH � Recent ( � Increased risk for bleeding complications (liver disease, recent haemorrhagic stroke, prior major bleeding or predisposition to bleeding, alcohol use) � Pregnant women � Severe renal impairment (GFR � 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Death All-cause Cardiovascular Non-Cardiovascular Specific causes Fatal bleed Hospital admission Pneumonia Acute Respiratory distress syndrome Acute medical care or admission to intensive care unit (ICU) Mechanical ventilation/ Extracorporeal membrane oxygenation (ECMO) Non-invasive ventilation/high flow oxygen Hospitalized on supplemental oxygen Hospitalized not requiring supplemental oxygen Hospitalized not requiring ongoing medical care Timepoint: 21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Bleeding (as defined by ISTH criteria [12, 13]) (at 21 and 50 days) o Frequency o Location o Treatment (transfusion and units of blood products transfused) o Severity (classified as major, clinically relevant non-major and minor Timepoint: 21 and 50 Days;Diagnosis of Ischemic strokeTimepoint: 21, 50, and 90 days;Diagnosis of VTE: Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)Timepoint: 21 and 50 days | — |
Countries
Australia, Austria, Belgium, Brazil, India, Russian Federation, South Africa, Spain, United Kingdom
Contacts
Public ContactDeepak Kumar
Tech Observer India
Outcome results
None listed