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Trial - IRCT20220412054515N1


Column Value
Trial registration number IRCT20220412054515N1
Full text link
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Dr. Akbar Fotuhi

Contact
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

vcr@tums.ac.ir

Registration date
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2022-05-04

Recruitment status
Last imported at : Aug. 30, 2022, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Open label

Center
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Exclusion criteria
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

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

Number of arms
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Tehran University of Medical Sciences

Inclusion age min
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Severe disease at enrollment

Severity scale
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

6: Severe disease at enrollment

Total sample size
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

220

primary outcome
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Cumulative 6-month survival

Notes
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase 3

Arms
Last imported at : May 5, 2022, 5:03 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"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"}]