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Trial - NCT04360824


Column Value
Trial registration number NCT04360824
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04360824

First author
Last imported at : March 3, 2023, noon
Source : ClinicalTrials.gov

Usha Perepu

Contact
Last imported at : March 3, 2023, noon
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-24

Recruitment status
Last imported at : March 3, 2023, noon
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - laboratory confirmed sars-cov-2 infection - age ≥18 years - requires hospital admission for further clinical management - modified isth overt dic score ≥ 3

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- indication for full therapeutic-dose anticoagulation - acute venous thromboembolism (deep vein thrombosis or pulmonary embolism) within prior 3 months - acute cardiovascular event within prior 3 months - acute stroke (ischemic or hemorrhagic) within prior 3 months - active major bleeding - severe thrombocytopenia (<25,000/mm3) - increased risk of bleeding, as assessed by the investigator - acute or chronic renal insufficiency with creatinine clearance < 30 ml/min calculated by the modified cockcroft and gault formula - weight < 40 kg - known allergies to ingredients contained in enoxaparin, allergy to heparin products or history of heparin induced thrombocytopenia

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

University of Iowa

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

No restriction on type of patients

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

0: No restriction on type of patients

Total sample size
Last imported at : March 3, 2023, noon
Source : ClinicalTrials.gov

176

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mortality

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "40 mg subcutaneously daily if BMI <40 and 30 mg subcutaneously twice daily if BMI \u2265 40", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "1 mg/kg Subcutaneously daily or 0.5 mg/kg Subcutaneously twice daily if BMI \u2265 40", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]