Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID-19

• Status: Recruiting
• Trial end date: 2022-04-14
• Target enrollment: 0
• Participant gender: All

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 disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Collaborators: Centre Hospitalier Universitaire Vaudois; Clinica Luganese Moncucco; Mainz University; Oncology Institute of Southern Switzerland; University Hospital Freiburg; University Hospital Inselspital, Berne; University Hospital, Basel, Switzerland; University Hospital, Geneva
• Treatments: Enoxaparin

Criteria

Inclusion Criteria:

1. Patients aged 50 years or older with a positive test for SARS-CoV2 in the past 5 days and eligible for ambulatory treatment.

2. Presence of respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or body temperature >37.5° C.

3. 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

4. Ability to comply with standard hygiene requirements at the time of in-hospital visit, including a face mask and hand disinfectant.

5. 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.

6. 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 Criteria:

1. Any acute or chronic condition posing an indication for anticoagulant treatment, e.g. atrial fibrillation, prior VTE, acute confirmed symptomatic VTE, acute coronary syndrome.

2. Anticoagulant thromboprophylaxis deemed necessary in view of the patient's history, comorbidity or predisposing strong risk factors for thrombosis:

1. 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,

2. previous VTE,

3. histologically confirmed malignancy, which was diagnosed or treated (surgery, chemotherapy, radiotherapy) in the past 6 months, or recurrent, or metastatic, or inoperable.

3. 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.

4. Intracerebral bleeding at any time in the past or signs/symptoms consistent with acute intracranial hemorrhage.

5. Hemoglobin <8 g/dL and platelet count <50 x 109 cells/L confirmed by recent laboratory test (<90 days).

6. Subjects with any known coagulopathy or bleeding diathesis, including known significant liver disease associated with coagulopathy.

7. Severe renal insufficiency (baseline creatinine clearance <30 mL/min calculated using the Cockcroft-Gault formula) confirmed by recent laboratory test (<90 days).

8. Contraindications to enoxaparin therapy, including prior heparin-induced thrombocytopenia and known hypersensitivity.

9. Current use of dual antiplatelet therapy.

10. Participation in other interventional studies over the past 30 days.

11. Non-compliance or inability to adhere to treatment or lack of a family environment or support system for home treatment.