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Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients

NCT04427098 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2024-12-03

No results posted yet for this study

Summary

General objective of the study To assess the efficacy and safety of enoxaparin in hospitalized patients with moderate to severe COVID-19 (Coronavirus Disease 2019) infection.

Study Design

The study consists of two parts:

* a phase II single-arm interventional prospective study including all patients treated with the study drug;
* an observational prospective cohort study including all patients screened for receiving the study drug but not included in the phase II study.

Patients will be enrolled from "date of study approval" for 1 month. Each patient will be followed-up for a minimum of 90 days after COVID19 diagnosis.

Conditions

Interventions

DRUG

Enoxaparin 40 Mg/0.4 mL Injectable Solution

Subcutaneous enoxaparin 40 mg once daily for 14 days.

DRUG

Enoxaparin

Subcutaneous enoxaparin for 14 days: 60 mg once daily in case of body weight of 45 to 60 kg; 80 mg once daily in case of weight from 61 to 100 kg; 100 mg once daily in case of bodyweight \>100 kg

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Pierluigi Viale, MD · Infectious Diseases Unit, Dep. Med. and Surg. Science University of Bologna

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-05-22
Primary Completion
2021-09-29
Completion
2021-09-29

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 NCT04427098 on ClinicalTrials.gov