Comparison of Two Doses of Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients (X-Covid 19)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04366960 |
Recruitment Status :
Completed
First Posted : April 29, 2020
Last Update Posted : June 8, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Covid19 | Drug: Enoxaparin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 189 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | None (Open Label) |
Masking Description: | Open label |
Primary Purpose: | Treatment |
Official Title: | Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients: Comparison of 40 mg o.d. Versus 40 mg b.i.d. A Randomized Clinical Trial |
Actual Study Start Date : | May 14, 2020 |
Actual Primary Completion Date : | May 25, 2021 |
Actual Study Completion Date : | May 25, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 40 mg subcutaneous enoxaparin o.d.
Effects of 40 mg subcutaneous enoxaparin o.d.
|
Drug: Enoxaparin
Subcutaneous enoxaparin |
Active Comparator: 40 mg subcutaneous enoxaparin b.i.d
Effects of 40 mg subcutaneous enoxaparin b.i.d
|
Drug: Enoxaparin
Subcutaneous enoxaparin |
- Incidence of venous thromboembolism detected by imaging [ Time Frame: 30 days ]Deep vein thrombosis events diagnosed by serial compression ultrasonography and pulmonary embolism events diagnosed by computed tomography scan
- In hospital major complications [ Time Frame: 30 days ]death, venous thromboembolism, use of mechanical ventilation, stroke, acute myocardial infarction and admission to an intensive care
- Number of deep venous thrombosis events [ Time Frame: 30 days ]Deep venous thrombosis events diagnosed by serial compression ultrasonography
- Sequential organ failure assessment [ Time Frame: 30 days ]
Maximum sequential organ failure assessment (SOFA) score comparison between the two groups.
The SOFA score ranges from 0 to 24. Higher SOFA score is associated with a greater risk of death or prolonged intensive care unit stay.
- C-reactive protein [ Time Frame: 30 days ]To compare C-reactive protein levels as % above the upper reference limit [URL]) among the two groups.
- Interleukin-6 [ Time Frame: 30 days ]To compare Interleukin-6 levels as % above the upper reference limit [URL]) among the two groups.
- D-dimer [ Time Frame: 30 days ]To D-dimer compare levels as % above the upper reference limit [URL]) among the two groups.
- hs-troponin levels [ Time Frame: 30 days ]To compare hs-troponin levels as % above the upper reference limit [URL]) among the two groups.
- Acute Respiratory Distress Syndrome [ Time Frame: 30 days ]To compare the incidence of SARS-CoV-2-related Acute Respiratory Distress Syndrome (ARDS) between the two groups.
- Hospital stay [ Time Frame: 30 days ]To compare length of hospital stay between the two groups.
- Right ventricular function [ Time Frame: 30 days ]To compare measures of right ventricular function at trans-thoracic echocardiography or CT between admission and follow-up, whenever available
- Number of pulmonary embolism events [ Time Frame: 30 days ]Pulmonary embolism events diagnosed by computed tomography scan

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366960
Italy | |
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | |
Milano, Italy, 20162 |
Responsible Party: | Niguarda Hospital |
ClinicalTrials.gov Identifier: | NCT04366960 |
Other Study ID Numbers: |
2020-001708-41 |
First Posted: | April 29, 2020 Key Record Dates |
Last Update Posted: | June 8, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID19 |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Enoxaparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |