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Enoxaparin at Prophylactic or Therapeutic Doses in COVID-19

NCT04646655 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-07-25

No results posted yet for this study

Summary

SINGLE CENTER PHASE III INTERVENTIONAL RANDOMIZED CONTROLLED TRIAL comparing efficacy and safety of enoxaparin at prophylactic dose (standard treatment) and enoxaparin at therapeutic dose (OFF-LABEL treatment) in 300 COVID-19 infected patients with moderate-severe respiratory failure (PaO2/FiO2\<250) and/or increased D-dimer levels enrolled in different Units (Infectious disease, Internal Medicine, Emergency Medicine, Pneumology) of Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco (ASST-FBF-SACCO).

Conditions

Interventions

DRUG

Enoxaparin

subcutaneous injections

Sponsors & Collaborators

  • Massimo Arquati

    collaborator UNKNOWN

  • Riccardo Colombo

    collaborator UNKNOWN

  • Umberto Russo

    collaborator UNKNOWN

  • Manuela Nebuloni

    collaborator UNKNOWN

  • Spinello Antinori

    collaborator UNKNOWN

  • ASST Fatebenefratelli Sacco

    lead OTHER

Principal Investigators

  • Maddalena A Wu, M.D. · ASST Fatebenefratelli Sacco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2022-10-16
Completion
2023-04-30

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 NCT04646655 on ClinicalTrials.gov