Trial registration number
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IRCT20220412054515N1 |
Full text link
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/62908
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First author
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Akbar Fotuhi
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Contact
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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vcr@tums.ac.ir
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Registration date
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2022-05-04
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Recruitment status
Last imported at : Aug. 30, 2022, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Open label
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Center
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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COVID-19 infection diagnosed by PCR
Hospitalization requirement
Having at least two signs of severe COVID-19 infection: (1) respiratory rate>30 (2) Spo2<93% (3) Pao2/Fio2<300 (4) progression in CT scan imaging>50% in 48 hours
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Exclusion criteria
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Pregnancy
History of CVA in last month
History of major surgery in last two weeks
History of heparin induced thrombocytopenia
Other definitive indications for therapeutic enoxaparin treatment
Any contraindication for enoxaparin treatment
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Number of arms
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Tehran University of Medical Sciences
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Inclusion age min
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe disease at enrollment
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Severity scale
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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6: Severe disease at enrollment
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Total sample size
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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220
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primary outcome
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Cumulative 6-month survival
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Notes
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "therapeutic dose", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "prevention dose", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]
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