Status:
TERMINATED
Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID-19
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Insel Gruppe AG, University Hospital Bern
University Hospital, Geneva
Conditions:
COVID-19
Pulmonary Embolism, Deep Vein Thrombosis
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The OVID study will show whether prophylactic-dose enoxaparin improves survival and reduces unplanned hospitalizations in ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral di...
Detailed Description
The following points represent, in summary, the rationale for studying the use of thromboprophylaxis in ambulatory patients with COVID-19: 1. The risk of thromboembolic events in patients with COVID-...
Eligibility Criteria
Inclusion
- Patients aged 50 years or older with a positive test for SARS-CoV2 in the past 5 days and eligible for ambulatory treatment.
- Presence of respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or body temperature \>37.5° C.
- Ability of the patient to travel to the study center by private transportation, performed either by accompanying person from same household or by the patient him/herself
- Ability to comply with standard hygiene requirements at the time of in-hospital visit, including a face mask and hand disinfectant.
- Ability to walk from car to study center or reach it using a wheel chair transport with the help of an accompanying person from the same household also complying with standard hygiene requirements.
- Ability to self-administer prefilled enoxaparin injections after instructions received at the study center or availability of a person living with the patient to administer enoxaparin.
Exclusion
- Any acute or chronic condition posing an indication for anticoagulant treatment, e.g. atrial fibrillation, prior VTE, acute confirmed symptomatic VTE, acute coronary syndrome.
- Anticoagulant thromboprophylaxis deemed necessary in view of the patient's history, comorbidity or predisposing strong risk factors for thrombosis:
- Any of the following events occurring in the prior 30 days: fracture of lower limb, hospitalization for heart failure, hip/knee replacement, major trauma, spinal cord injury, stroke,
- previous VTE,
- histologically confirmed malignancy, which was diagnosed or treated (surgery, chemotherapy, radiotherapy) in the past 6 months, or recurrent, or metastatic, or inoperable.
- Any clinically relevant bleeding (defined as bleeding requiring hospitalization, transfusion, surgical intervention, invasive procedures, occurring in a critical anatomical site, or causing disability) within 30 days prior to randomization or sign of acute bleeding.
- Intracerebral bleeding at any time in the past or signs/symptoms consistent with acute intracranial hemorrhage.
- Hemoglobin \<8 g/dL and platelet count \<50 x 109 cells/L confirmed by recent laboratory test (\<90 days).
- Subjects with any known coagulopathy or bleeding diathesis, including known significant liver disease associated with coagulopathy.
- Severe renal insufficiency (baseline creatinine clearance \<30 mL/min calculated using the Cockcroft-Gault formula) confirmed by recent laboratory test (\<90 days).
- Contraindications to enoxaparin therapy, including prior heparin-induced thrombocytopenia and known hypersensitivity.
- Current use of dual antiplatelet therapy.
- Participation in other interventional studies over the past 30 days.
- Non-compliance or inability to adhere to treatment or lack of a family environment or support system for home treatment.
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2022
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT04400799
Start Date
June 15 2020
End Date
April 12 2022
Last Update
May 25 2022
Active Locations (8)
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1
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
2
Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55122
3
University Hospital Basel
Basel, Switzerland, 4031
4
Clinic of Hematology, Oncology Institute of Southern Switzerland
Bellinzona, Switzerland