Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID-19

• Register: ClinicalTrials.gov
• Last refreshed on: 30 May 2022
• Main ID: NCT04400799
• Date of registration: 15/05/2020
• Prospective Registration: Yes
• Primary sponsor: University of Zurich
• Public title: Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID-19
• Scientific title: Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With Coronavirus: The Multicenter Randomized Controlled Ovid Trial
• Date of first enrolment: June 15, 2020
• Target sample size: 475
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT04400799
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Germany, Switzerland

Contacts

• Name: Nils Kucher, Prof.
• Affiliation: University of Zurich

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Embolism, Deep Vein Thrombosis

COVID-19

Intervention(s)

Drug: Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml

Primary Outcome(s)

all-cause death [Time Frame: 30 days]

hospitalizations [Time Frame: 30 days]

Secondary Outcome(s)

all-cause death [Time Frame: within 14 days, 30 days, and 90 days of randomization]

Disseminated intravascular coagulation [Time Frame: within 14 days, 30 days, and 90 days of enrolment]

any hospitalizations [Time Frame: within 14 days, 30 days, and 90 days of randomization]

Number of cardiovascular events [Time Frame: within 14 days, 30 days, and 90 days of randomization]

Net clinical benefit [Time Frame: within 14 days, 30 days, and 90 days of enrolment.]

Secondary ID(s)

OVID Trial

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centre Hospitalier Universitaire Vaudois

University Hospital Inselspital, Berne

Mainz University

Clinica Luganese Moncucco

Oncology Institute of Southern Switzerland

University Hospital Freiburg

University Hospital, Basel, Switzerland

University Hospital, Geneva