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

NCT04408235 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-05-29

No results posted yet for this study

Summary

Randomized, controlled study conducted in hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation.

Aim of this study is to assess whether high doses of Low Molecular Weight Heparin (LMWH) (ie. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (ie, Enoxaparin 4000 IU once day) are:

1. More effective to prevent clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first, during hospital stay:

1. Death
2. Acute Myocardial Infarction \[AMI\]
3. Objectively confirmed, symptomatic arterial or venous thromboembolism \[TE\]
4. Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients who are in standard oxygen therapy by delivery interfaces at randomisation
5. Need for invasive mechanical ventilation for patients who are in non-invasive mechanical ventilation at randomisation
2. Similar in terms of major bleeding risk during hospital stay

Conditions

  • COVID
  • Pneumonia, Viral
  • Coagulation Disorder

Interventions

DRUG

Enoxaparin

Low-Dose LMWH: enoxaparin 4000 IU daily; High dose LMWH: 70 IU/kg twice daily

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria di Modena

    lead OTHER

Principal Investigators

  • Marco Marietta, MD · Azienda Ospedaliero-Universitaria di Modena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04408235 on ClinicalTrials.gov