Randomised controlled trial comparing efficacy and safety of high versus low low-molecular weight heparin dosages in hospitalised patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD)

Phase 1

• Conditions: Hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation.; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001972-13-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-26
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients admitted to the hospital with COVID-19 confirmed by PCR test on throat swab samples, and with severe pneumonia plus coagulopathy, defined as the presence of at least one clinical and one laboratory criteria.
Clinical criteria (at least one)
1) Respiratory Rate = 25 breaths /min
2) Arterial oxygen saturation = 93% at rest in room air
3) PaO2/FiO2 = 300 mmHg
Laboratory criteria and SIC score (at least one )
1) D-dimer > 4 times the upper level of normal reference range
2) Sepsis-Induced Coagulopathy (SIC) score > 4
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1.Age < 18 and > 80 years
2.Invasive ventilation
3.Thrombocytopenia (platelet count < 80.000 mm3)
4.Coagulopathy: INR >1.5, aPTT ratio >1.4
5.Impaired renal function (eGFR by CKD-EPI Creatinine equation < 30 ml/min)
6.Known hypersensitivity to enoxaparin
7.History of heparin induced thrombocytopenia
8.Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignant tumors at high risk of haemorrhages, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations)
9.Concomitant anticoagulant treatment for other indications (e.g. atrial fibrillation, venous thromboembolism, prosthetic heart valves)
10.Concomitant double antiplatelet therapy
11.Administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization; prophylactic doses are allowed
12.Pregnancy or breastfeeding or positive pregnancy test
13.Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition)
14.Lack or withdrawal of informed consent

Study & Design

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