Comparison of Two Doses of Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-14

Study Completion Date

2021-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether a higher dose of low molecular weight heparin (enoxaparin 40 mg b.i.d.) is superior than the standard prophylaxis dose (enoxaparin 40 mg o.d.) in reducing thromboembolic events in COVID-19 patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19

NCT04646655

Covid19 Thrombosis

COMPLETED PHASE3

High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy

NCT04408235

COVID Pneumonia, Viral Coagulation Disorder

UNKNOWN PHASE3

Full Dose Heparin Vs. Prophylactic Or Intermediate Dose Heparin in High Risk COVID-19 Patients

NCT04401293

Sars-CoV2 COVID

COMPLETED PHASE3

Safety and Efficacy of Therapeutic Anticoagulation on Clinical Outcomes in Hospitalized Patients With COVID-19

NCT04377997

Cardiovascular Diseases COVID-19

UNKNOWN PHASE2

Early Prophylactic Low-molecular-weight Heparin (LMWH) in Symptomatic COVID-19 Positive Patients

NCT04492254

COVID-19

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Coronavirus disease-19 (COVID-19 ), which is caused by SARS-CoV-2 infection, are apparently at high risk of venous thromboembolism (VTE), as a consequence of activation of the hemostatic system which, in the most severe cases, can also be associated with the formation of microthrombi and clinically relevant disseminated intravascular coagulation. Concerns about the efficacy of thromboprophylaxis with standard doses of low-molecular-weight heparin (LMWH) has been raised. Therefore, LMWH at higher doses than those recommended for thromboprophylaxis is used in some hospitals, although no evidence exists yet of higher efficacy of high doses compared to standard prophylactic doses. This practice might as well increase the risk of major bleeding. The investigators designed a randomized trial comparing standard prophylactic dose of subcutaneous enoxaparin (40 mg o.d.) with higher dose (40 mg b.i.d) with the aim of testing whether high-dose thromboprophylaxis is more effective than standard dose in preventing VTE in COVID-19 patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label Multicentre Prospective Controlled Randomized Trial in patients with SARS-CoV-2 infection. Patients will be randomized 1:1 to 40 mg subcutaneous enoxaparin o.d. versus 40 mg enoxaparin b.i.d within 12 hours after hospitalization.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

40 mg subcutaneous enoxaparin o.d.

Effects of 40 mg subcutaneous enoxaparin o.d.

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Subcutaneous enoxaparin

40 mg subcutaneous enoxaparin b.i.d

Effects of 40 mg subcutaneous enoxaparin b.i.d

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Subcutaneous enoxaparin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Enoxaparin

Subcutaneous enoxaparin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All-comers patients aged \>=18 years and admitted to hospital with laboratory-confirmed SARS-CoV-2 infection

Exclusion Criteria

* Patients admitted directly to an intensive care unit;
* Estimated creatinine clearance \<15 ml/min/1.73m2;
* Patients needing anticoagulant for prior indication;
* Participants involved in other clinical trials;
* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No