Status:
COMPLETED
Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
COVID-19
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
General objective of the study To assess the efficacy and safety of enoxaparin in hospitalized patients with moderate to severe COVID-19 infection. Specific objectives Primary Endpoints To investigat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2021
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT04427098
Start Date
May 22 2020
End Date
September 29 2021
Last Update
December 3 2024
Active Locations (13)
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1
Policlinico S. Orsola Malpighi Dipartimento Malattie Infettive
Bologna, Emilia-Romagna, Italy, 40138
2
Azienda Ospedaliero-Universitaria di Parma Anestesia e Rianimazione Dipartimento di Medicina e Chirurgia
Parma, Emilia-Romagna, Italy
3
I.R.C.C.S. "Casa Sollievo della Sofferenza", San Giovanni Rotondo (FG) UOVD Emostasi e trombosi- Poliambulatorio Giovanni Paolo II Viale Padre Pio n.7 San Giovanni Rotondo (FG)
San Giovanni Rotondo, Foggia, Italy
4
Fondazione Poliambulanza Chirurgia Vascolare
Brescia, Italy