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| Column | Value |
|---|---|
| Trial registration number | EUCTR2020-005884-29-IT |
|
Full text link
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005884-29/IT |
|
First author
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
|
|
Contact
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
mariacristina.vedovati@unipg.it |
|
Registration date
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
2021-06-08 |
|
Recruitment status
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
Recruiting |
|
Study design
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
RCT |
|
Allocation
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
Randomized |
|
Design
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
Parallel |
|
Masking
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
Open label |
|
Center
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
multi-center |
|
Study aim
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
Treatment |
|
Inclusion criteria
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
Inclusion criteria: - Age >= 18 years - Diagnosis of COVID-19 confirmed by RT-PCR with pneumonia detected by chest X-ray or ultrasonography or computed tomography - Severe respiratory failure (PaO2/FiO2 <250) - Informed consent Criteri di inclusione: - Età >= 18 anni - Diagnosi di COVID-19 confermata da RT-PCR con polmonite rilevata mediante radiografia del torace o ecografia o tomografia computerizzata - Grave insufficienza respiratoria (PaO2 / FiO2 <250) - Consenso informato |
|
Exclusion criteria
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
Exclusion criteria: - Need for invasive mechanical ventilation - Any contraindication to LMWH (known hypersensitivity, history of heparin induced thrombocytopenia, stage IV or V renal failure,.. ) - Platelet count <30000/mmc - Indication for therapeutic anticoagulation - Evidence of active bleeding - Recent stroke in the preceding 4 weeks - Women who are pregnant or breastfeeding Criteri di esclusione: - Necessità di ventilazione meccanica invasiva - Qualsiasi controindicazione alla EBPM (ipersensibilità nota, storia di trombocitopenia indotta da eparina, insufficienza renale di stadio IV o V, ..) - Conta piastrinica <30000/mmc - Indicazione ad anticoagulanti a dose terapeutica - Evidenza di sanguinamento attivo - Ictus recente nelle 4 settimane precedenti - Donne con gravidanza in corso o in allattamento |
|
Number of arms
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
6 |
|
Funding
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
UNIVERSITà DEGLI STUDI DI PERUGIA |
|
Inclusion age min
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
18 |
|
Inclusion age max
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
100 |
|
Countries
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
Italy |
|
Type of patients
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
Severe disease at enrollment |
|
Severity scale
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
6: Severe disease at enrollment |
|
Total sample size
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
652 |
|
primary outcome
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
The primary study outcome is the composite of all-cause death or respiratory failure requiring invasive mechanical ventilation or confirmed venous thromboembolism, whichever comes first, within 28 days from randomization. L’outcome principale dello studio è il composito di morte per tutte le cause o insufficienza respiratoria che richiede ventilazione meccanica invasiva o tromboembolismo venoso confermato, entro 28 giorni dalla randomizzazione. |
|
Notes
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
Declared number of arm (2.0) differs from found arms (6.0) |
|
Phase
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
Phase 3 |
|
Arms
Last imported at : Aug. 25, 2021, 11:30 p.m. Source : EU Clinical Trials Register |
[{"arm_notes": "", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1817, "treatment_name": "Parnaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 377, "treatment_name": "Dalteparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 853, "treatment_name": "Nadroparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 192, "treatment_name": "Bemiparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1814, "treatment_name": "Reviparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}] |