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Trial - NCT04650087


Column Value
Trial registration number NCT04650087
Full text link
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04650087

First author
Last imported at : July 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : July 12, 2022, 1:30 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-12-02

Recruitment status
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Adaptive

Masking
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - • age ≥ 18 years - pcr-positive covid-19 infection - hospitalized for two or more days

Exclusion criteria
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

- pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein thrombosis; atrial fibrillation; mechanical cardiac valve) - contraindication to antithrombotic therapy (e.g., known bleeding within the last 30 days requiring emergency room presentation or hospitalization; major surgery within 14 days; ischemic stroke, intracranial bleed or neurosurgery within 3 months. - platelet count < 50,000/mcl - hemoglobin <8 gm/dl - renal insufficiency (egfr < 30 ml/min/1.73 m2) - pregnancy - prison inmate - life expectancy less than 90 days - unwilling or unable to provide informed consent/unwilling or unable to complete the study protocol - dual antiplatelet therapy that cannot be discontinued - concomitant need for strong inducers/inhibitors of p-gp or cyp3a4

Number of arms
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Thomas L. Ortel

Inclusion age min
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

100

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

United States

Type of patients
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : Sept. 28, 2022, 5:30 a.m.
Source : ClinicalTrials.gov

1219

primary outcome
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality as measured by hospital records.

Notes
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

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

Phase 3

Arms
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 110, "treatment_name": "Apixaban", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]