Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID-19

NCT04400799 | Terminated Phase 3 DMC

• 1 other identifier: OVID Trial
• Study Type: interventional
• Target: 475
• Locations: 2 countries
• Sites: 8

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

Conditions

COVID-19; Pulmonary Embolism, Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (2)

• hospitalizations

  30 days

• all-cause death

  30 days

Secondary Outcomes (5)

• Number of cardiovascular events

  within 14 days, 30 days, and 90 days of randomization

• any hospitalizations

  within 14 days, 30 days, and 90 days of randomization

• all-cause death

  within 14 days, 30 days, and 90 days of randomization

• Net clinical benefit

  within 14 days, 30 days, and 90 days of enrolment.

• Disseminated intravascular coagulation

  within 14 days, 30 days, and 90 days of enrolment

Study Arms (2)

Test Group

EXPERIMENTAL

Enoxaparin (Clexane®) will be given at the recommended dose of 4,000 IU antiXa activity (40 mg/0.4 ml) once daily by SC injection for 14 days.

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

Control Group

NO INTERVENTION

No study drug

Interventions

Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml DRUG

daily incetion s.c. for 14 days

Test Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital, Geneva: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator
• University Hospital, Basel, Switzerland: collaborator
• Oncology Institute of Southern Switzerland: collaborator
• Clinica Luganese Moncucco: collaborator
• University Hospital Freiburg: collaborator
• Mainz University: collaborator

Study Sites (8)

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Johannes Gutenberg-Universität Mainz

Mainz, 55122, Germany

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

Clinic of Hematology, Oncology Institute of Southern Switzerland

Bellinzona, Switzerland

Location

University Hospital Bern

Bern, Switzerland

Location

Hôpitaux Universitaires Genève

Geneva, Switzerland

Location

Clinica Luganese Moncucco

Lugano, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (3)

• Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.

  PMID: 37591523 DERIVED

• Barco S, Voci D, Held U, Sebastian T, Bingisser R, Colucci G, Duerschmied D, Frenk A, Gerber B, Gotschi A, Konstantinides SV, Mach F, Robert-Ebadi H, Rosemann T, Simon NR, Spechbach H, Spirk D, Stortecky S, Vaisnora L, Righini M, Kucher N; OVID investigators. Enoxaparin for primary thromboprophylaxis in symptomatic outpatients with COVID-19 (OVID): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet Haematol. 2022 Aug;9(8):e585-e593. doi: 10.1016/S2352-3026(22)00175-2. Epub 2022 Jun 30.

  PMID: 35779558 DERIVED

• Barco S, Bingisser R, Colucci G, Frenk A, Gerber B, Held U, Mach F, Mazzolai L, Righini M, Rosemann T, Sebastian T, Spescha R, Stortecky S, Windecker S, Kucher N. Enoxaparin for primary thromboprophylaxis in ambulatory patients with coronavirus disease-2019 (the OVID study): a structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Sep 9;21(1):770. doi: 10.1186/s13063-020-04678-4.

  PMID: 32907635 DERIVED

MeSH Terms

Conditions

COVID-19; Pulmonary Embolism; Venous Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Nils Kucher, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 26, 2020
• Study Start: June 15, 2020
• Primary Completion: February 7, 2022
• Study Completion: April 12, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (6); DE (2)