Exoxaparin in hospitalized patients with moderate-severe COVID19

Phase 1

• Conditions: Hospitalized adult patients with microbiologically confirmed moderate-severe COVID-19 infection; MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001308-40-IT
• Lead Sponsor: ALMA MATER STUDIORUM UNIVERSITà DI BOLOGNA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

-Age >=18 y
-Microbiologically confirmed COVID-19 infection
-Patients with moderate-severe disease according to study definitions (see below)
-Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

•Thrombocytopenia (platelet count < 50.000 mm3)
•Coagulopathy: INR >1.5, aPTT ratio >1.4
•Impaired renal function (clearance to creatinine less than 15 ml/min)
•Known hypersensitivity to heparin
•History of heparin induced thrombocytopenia
•Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignat tumors at hig risk of haemorrahges, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations)
•Body weight <45 or > 150 kg
•Concomitant anticoagulant treatment for other indications ( eg atrial fibrillation, venous thromboembolism , prosthetic heart valves).
•Dual antiplatelet therapy
•Pregnant or breastfeeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of enoxaparin in improving the clinical outcome of hospitalized patients with moderate-severe COVID-19.;Secondary Objective: To analyse the safety of enoxaparin in hospitalized patients with with moderate-severe COVID-19.;Primary end point(s): •All-cause in-hospital, 30-day and 90-day mortality rates.<br>•Evolution of the clinical severity during treatment.<br>•ICU admission and length of ICU stay.<br>•Length of hospital stay.;Timepoint(s) of evaluation of this end point: 30 day and 90 day

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Proportion of patients in the severe or critical stage of disease at the end of treatment<br>•Proportion of patients who develop major and non-major bleeding events<br>•Time to first negative RT-PCR on nasofaringeal swab <br>•Reduction of viral load in blood;Timepoint(s) of evaluation of this end point: 90 day