Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients

• Status: Recruiting
• Trial end date: 2020-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi; IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Treatments: Enoxaparin; Enoxaparin sodium

Criteria

Inclusion Criteria:

• For both interventional study and observational cohort, hospitalized patients are eligible to be included if the following criteria apply:

Inclusion criteria:

• Age >=18 y

• Microbiologically confirmed COVID-19 infection

• Patients with moderate to severe disease according to study definitions (see below)

• Informed consent to participate and to use data for interventional study, only to use data for observational cohort

Exclusion Criteria:

• Participants are excluded from the interventional study if any of the following criteria apply:

• Thrombocytopenia (platelet count < 50.000 mm3)

• Coagulopathy: INR (International normalized ratio) >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, malignant tumors at hig risk of haemorrhages, 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 breast-feeding women