NCT04366960

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P25-P50 for phase_3 covid19

Timeline
Completed

Started May 2020

Typical duration for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

May 14, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

April 24, 2020

Last Update Submit

June 7, 2021

Conditions

Covid19

Keywords

COVID19

Outcome Measures

Primary Outcomes (1)

  • Incidence of venous thromboembolism detected by imaging

    Deep vein thrombosis events diagnosed by serial compression ultrasonography and pulmonary embolism events diagnosed by computed tomography scan

    30 days

Secondary Outcomes (11)

  • In hospital major complications

    30 days

  • Number of deep venous thrombosis events

    30 days

  • Sequential organ failure assessment

    30 days

  • C-reactive protein

    30 days

  • Interleukin-6

    30 days

  • +6 more secondary outcomes

Study Arms (2)

40 mg subcutaneous enoxaparin o.d.

ACTIVE COMPARATOR

Effects of 40 mg subcutaneous enoxaparin o.d.

Drug: Enoxaparin

40 mg subcutaneous enoxaparin b.i.d

ACTIVE COMPARATOR

Effects of 40 mg subcutaneous enoxaparin b.i.d

Drug: Enoxaparin

Interventions

EnoxaparinDRUG

Subcutaneous enoxaparin

40 mg subcutaneous enoxaparin b.i.d40 mg subcutaneous enoxaparin o.d.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

Related Publications (3)

  • Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

    PMID: 35244208DERIVED

  • Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.

    PMID: 33502773DERIVED

  • Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 2020 Jun;7(6):e438-e440. doi: 10.1016/S2352-3026(20)30145-9. Epub 2020 May 11. No abstract available.

    PMID: 32407672DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 29, 2020

Study Start

May 14, 2020

Primary Completion

May 25, 2021

Study Completion

May 25, 2021

Last Updated

June 8, 2021

Record last verified: 2021-06

Locations

IT(1)